Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT03764293
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2018-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC
Sponsor:
Organization:
Raw JSON
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The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Camrelizumab+Rivoceranib Arm', 'description': 'Camrelizumab+rivoceranib arm: Rivoceranib 250 mg orally, QD, within 30 minutes after a meal, continuously.\n\nCamrelizumab 200 mg IV infusion, over 30 minutes, Q2W. The interval between two doses should not be less than 12 days.', 'otherNumAtRisk': 272, 'deathsNumAtRisk': 272, 'otherNumAffected': 268, 'seriousNumAtRisk': 272, 'deathsNumAffected': 34, 'seriousNumAffected': 114}, {'id': 'EG001', 'title': 'Sorafenib Arm', 'description': 'Sorafenib arm: Sorafenib 400 mg orally, BID, in a fasted state (at least 1 hour before or 2 hours after a meal), continuously.', 'otherNumAtRisk': 269, 'deathsNumAtRisk': 269, 'otherNumAffected': 262, 'seriousNumAtRisk': 269, 'deathsNumAffected': 17, 'seriousNumAffected': 49}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 48}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 20}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 114}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 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'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 178}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 137}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 154}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 115}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 138}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 105}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 131}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 112}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 80}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 48}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 33}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 70}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 56}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 52}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood bilirubin unconjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 33}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 37}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Total bile acids increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary occult blood positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Occult blood positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 62}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 46}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 34}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 48}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 136}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 82}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 18}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 163}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 55}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 52}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 190}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 118}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Immune-mediated enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastriculcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Immune-mediated pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incarcerated inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric varices haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oesophageal varices haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 10}, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urethral neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 2}], 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'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Biloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, 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'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulcerative keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteonecrosis of jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Affective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camrelizumab+Rivoceranib Arm', 'description': 'Camrelizumab+rivoceranib arm: Rivoceranib 250 mg orally, QD, within 30 minutes after a meal, continuously.\n\nCamrelizumab 200 mg IV infusion, over 30 minutes, Q2W. The interval between two doses should not be less than 12 days.'}, {'id': 'OG001', 'title': 'Sorafenib Arm', 'description': 'Sorafenib arm: Sorafenib 400 mg orally, BID, in a fasted state (at least 1 hour before or 2 hours after a meal), continuously.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '27.2'}, {'value': '15.2', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '18.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 3 years', 'description': 'OS was defined as the time from randomization to death from any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) Evaluated by the Blinded Independent Review Committee (BIRC) Based on RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camrelizumab+Rivoceranib Arm', 'description': 'Camrelizumab+rivoceranib arm: Rivoceranib 250 mg orally, QD, within 30 minutes after a meal, continuously.\n\nCamrelizumab 200 mg IV infusion, over 30 minutes, Q2W. The interval between two doses should not be less than 12 days.'}, {'id': 'OG001', 'title': 'Sorafenib Arm', 'description': 'Sorafenib arm: Sorafenib 400 mg orally, BID, in a fasted state (at least 1 hour before or 2 hours after a meal), continuously.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '7.4'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '3.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 3 years', 'description': 'PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) by tumor image evaluation or death from any cause whichever occurs first as determined by BIRC according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions and the sum of diameters must also demonstrate an absolute increase of \\>/= 5 millimeters (mm), or a measurable increase in a non-target lesion, or the appearance of new lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camrelizumab+Rivoceranib Arm', 'description': 'Camrelizumab+rivoceranib arm: Rivoceranib 250 mg orally, QD, within 30 minutes after a meal, continuously.\n\nCamrelizumab 200 mg IV infusion, over 30 minutes, Q2W. The interval between two doses should not be less than 12 days.'}, {'id': 'OG001', 'title': 'Sorafenib Arm', 'description': 'Sorafenib arm: Sorafenib 400 mg orally, BID, in a fasted state (at least 1 hour before or 2 hours after a meal), continuously.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '31'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 3 years', 'description': 'ORR defined as the percentage of subjects with complete response (CR) or partial response (PR) evaluated by the BIRC or investigator based on RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Overall Response (OR)=CR+PR.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camrelizumab+Rivoceranib Arm', 'description': 'Camrelizumab+rivoceranib arm: Rivoceranib 250 mg orally, QD, within 30 minutes after a meal, continuously.\n\nCamrelizumab 200 mg IV infusion, over 30 minutes, Q2W. The interval between two doses should not be less than 12 days.'}, {'id': 'OG001', 'title': 'Sorafenib Arm', 'description': 'Sorafenib arm: Sorafenib 400 mg orally, BID, in a fasted state (at least 1 hour before or 2 hours after a meal), continuously.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '83'}, {'value': '54', 'groupId': 'OG001', 'lowerLimit': '48', 'upperLimit': '60'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 3 years', 'description': 'DCR defined as the percentage of subjects with complete response, partial response or stable disease (SD) ≥ 8 weeks evaluated by the BIRC or investigator based on RECIST v1.1. Complete response (CR) was defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camrelizumab+Rivoceranib Arm', 'description': 'Camrelizumab+rivoceranib arm: Rivoceranib 250 mg orally, QD, within 30 minutes after a meal, continuously.\n\nCamrelizumab 200 mg IV infusion, over 30 minutes, Q2W. The interval between two doses should not be less than 12 days.'}, {'id': 'OG001', 'title': 'Sorafenib Arm', 'description': 'Sorafenib arm: Sorafenib 400 mg orally, BID, in a fasted state (at least 1 hour before or 2 hours after a meal), continuously.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'comment': 'NA=the 75-percentile DOR is not reached and hence the upper limit of the 95% CI of the median DOR is not estimable due to a lot of censoring and not enough disease progressions/events.', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': 'NA'}, {'value': '9.2', 'comment': 'NA=the 75-percentile DOR is not reached and hence the upper limit of the 95% CI of the median DOR is not estimable due to a lot of censoring and not enough disease progressions/events.', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 3 years', 'description': 'DOR defined as time from the date of first record of objective response (CR or PR) to the first occurrence of radiological progression or death, whichever comes first, evaluated by the BIRC or investigator based on RECIST v1.1. Complete response (CR) was defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Camrelizumab+Rivoceranib Arm', 'description': 'Camrelizumab+rivoceranib arm: Rivoceranib 250 mg orally, QD, within 30 minutes after a meal, continuously.\n\nCamrelizumab 200 mg IV infusion, over 30 minutes, Q2W. The interval between two doses should not be less than 12 days.'}, {'id': 'FG001', 'title': 'Sorafenib Arm', 'description': 'Sorafenib arm: Sorafenib 400 mg orally, BID, in a fasted state (at least 1 hour before or 2 hours after a meal), continuously.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '271'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '269'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '249'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '22'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '543', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Camrelizumab+Rivoceranib Arm', 'description': 'Camrelizumab+rivoceranib arm: Rivoceranib 250 mg orally, QD, within 30 minutes after a meal, continuously.\n\nCamrelizumab 200 mg IV infusion, over 30 minutes, Q2W. The interval between two doses should not be less than 12 days.'}, {'id': 'BG001', 'title': 'Sorafenib Arm', 'description': 'Sorafenib arm: Sorafenib 400 mg orally, BID, in a fasted state (at least 1 hour before or 2 hours after a meal), continuously.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 Years', 'categories': [{'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}]}, {'title': '>=65 Years', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '457', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '450', 'groupId': 'BG002'}]}]}, {'title': 'Black Or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-21', 'size': 3775095, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-06T00:31', 'hasProtocol': True}, {'date': '2022-04-19', 'size': 1517291, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-06T00:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 543}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2018-11-28', 'resultsFirstSubmitDate': '2023-11-10', 'studyFirstSubmitQcDate': '2018-12-03', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-05', 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 3 years', 'description': 'OS was defined as the time from randomization to death from any cause.'}, {'measure': 'Progression-free Survival (PFS) Evaluated by the Blinded Independent Review Committee (BIRC) Based on RECIST v1.1', 'timeFrame': 'Up to approximately 3 years', 'description': 'PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) by tumor image evaluation or death from any cause whichever occurs first as determined by BIRC according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions and the sum of diameters must also demonstrate an absolute increase of \\>/= 5 millimeters (mm), or a measurable increase in a non-target lesion, or the appearance of new lesions.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 3 years', 'description': 'ORR defined as the percentage of subjects with complete response (CR) or partial response (PR) evaluated by the BIRC or investigator based on RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Overall Response (OR)=CR+PR.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Up to approximately 3 years', 'description': 'DCR defined as the percentage of subjects with complete response, partial response or stable disease (SD) ≥ 8 weeks evaluated by the BIRC or investigator based on RECIST v1.1. Complete response (CR) was defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 3 years', 'description': 'DOR defined as time from the date of first record of objective response (CR or PR) to the first occurrence of radiological progression or death, whichever comes first, evaluated by the BIRC or investigator based on RECIST v1.1. Complete response (CR) was defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced or Metastatic and Unresectable HCC']}, 'referencesModule': {'references': [{'pmid': '41308676', 'type': 'DERIVED', 'citation': 'Qin S, Gu S, Chan SL, Bai Y, Ren Z, Lin X, Chen Z, Jia W, Jin Y, Guo Y, Hu X, Meng Z, Liang J, Xiong J, Ren H, Yang F, Li W, Chen Y, Zeng Y, Xu L, Yuan X, Li D, Sultanbaev A, Pazgan-Simon M, Pisetska M, Melisi D, Ponomarenko D, Du J, Shi W, Cheng AL, Kaseb A, Vogel A; CARES-310 Study Group. Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): final analysis of a randomised, open-label, international, phase 3 study. Lancet Oncol. 2025 Dec;26(12):1598-1611. doi: 10.1016/S1470-2045(25)00543-1.'}, {'pmid': '37499670', 'type': 'DERIVED', 'citation': 'Qin S, Chan SL, Gu S, Bai Y, Ren Z, Lin X, Chen Z, Jia W, Jin Y, Guo Y, Hu X, Meng Z, Liang J, Cheng Y, Xiong J, Ren H, Yang F, Li W, Chen Y, Zeng Y, Sultanbaev A, Pazgan-Simon M, Pisetska M, Melisi D, Ponomarenko D, Osypchuk Y, Sinielnikov I, Yang TS, Liang X, Chen C, Wang L, Cheng AL, Kaseb A, Vogel A; CARES-310 Study Group. Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study. Lancet. 2023 Sep 30;402(10408):1133-1146. doi: 10.1016/S0140-6736(23)00961-3. Epub 2023 Jul 24.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus sorafenib as first-line therapy in patients with advanced HCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histopathologically or cytologically confirmed advanced HCC\n* No previous systematic treatment for HCC\n* Have at least one measurable lesion (in accordance with RECIST v1.1)\n* BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy\n* ECOG-PS score 0 or 1\n* Child-Pugh Class: Grade A\n* Life Expectancy of at least 12 weeks\n* Subjects with HBV infection: HBV DNA\\<500 IU/ml or \\< 2500 copy/mL, and have received anti-HBV therapy for at least 14 days prior to enrollment in the study\n* Subjects with HCV-RNA(+) must receive antiviral therapy\n* Adequate organ function\n\nExclusion Criteria:\n\n* Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously\n* Moderate-to-severe ascites with clinical symptoms\n* History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage\n* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment\n* Known genetic or acquired hemorrhage or thrombotic tendency\n* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment\n* Cardiac clinical symptom or disease that is not well controlled\n* Hypertension that can not be well controlled through antihypertensive drugs\n* Factors to affect oral administration\n* History of hepatic encephalopathy\n* Previous or current presence of metastasis to central nervous system\n* HIV infection\n* Combined hepatitis B and hepatitis C co-infection\n* Be ready for or previously received organ or allogenic bone marrow transplantation\n* Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity\n* Active known, or suspected autoimmune disease\n* Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first administration of study treatment\n* Use of potent CYP3A4 inducers or inhibitors within 2 weeks prior to the signature of ICF\n* Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug\n* Severe infection within 4 weeks prior to the start of study treatment\n* Palliative radiotherapy for non-target lesions to control symptoms is allowed, but it must be completed at least 2 weeks prior to the start of study treatment\n* Treatment of other investigational product(s) within 28 days prior to the start of study treatment'}, 'identificationModule': {'nctId': 'NCT03764293', 'briefTitle': 'A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Randomized, Open-Label, International, Multi-Center, Phase 3 Clinical Study of PD-1 Antibody SHR-1210 Plus Apatinib Mesylate Versus Sorafenib as First-Line Therapy in Patients With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Therapy', 'orgStudyIdInfo': {'id': 'SHR-1210-III-310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-1210', 'description': 'SHR-1210+Apatinib', 'interventionNames': ['Drug: SHR-1210', 'Drug: Apatinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Sorafenib', 'interventionNames': ['Drug: Sorafenib']}], 'interventions': [{'name': 'SHR-1210', 'type': 'DRUG', 'otherNames': ['Camrelizumab'], 'description': 'Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial', 'armGroupLabels': ['SHR-1210']}, {'name': 'Apatinib', 'type': 'DRUG', 'otherNames': ['Rivoceranib'], 'description': 'Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet', 'armGroupLabels': ['SHR-1210']}, {'name': 'Sorafenib', 'type': 'DRUG', 'description': 'Subjects receive Sorafenib orally, Dosage form: tablet, Strength: 0.2 g/tablet', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Beverly Hills Cancer Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 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