Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-25 @ 3:50 PM
Study NCT ID:
NCT05976568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-04
First Post:
2023-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'C000632826', 'term': 'sintilimab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 668}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-28', 'studyFirstSubmitDate': '2023-07-28', 'studyFirstSubmitQcDate': '2023-07-28', 'lastUpdatePostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) (Phase II)', 'timeFrame': 'Up to approximately 4 years', 'description': 'ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).'}, {'measure': 'Incidence of Adverse Events (AEs) (Phase II)', 'timeFrame': 'Up to approximately 4 years', 'description': 'An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.'}, {'measure': 'Overall Survival (OS) (Phase III)', 'timeFrame': 'Up to approximately 4 years', 'description': 'OS was defined as the time from randomization to death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 4 years', 'description': 'ORR was assessed by investigators per RECIST 1.1'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Up to approximately 4 years', 'description': 'DCR was assessed by investigators per RECIST 1.1'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 4 years', 'description': 'DOR was assessed by investigators per RECIST 1.1'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Up to approximately 4 years', 'description': 'PFS was assessed by investigators per RECIST 1.1'}, {'measure': 'Time to progression (TTP)', 'timeFrame': 'Up to approximately 4 years', 'description': 'TTP was assessed by investigators per RECIST 1.1'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 4 years', 'description': 'ORR was assessed by investigators per mRECIST'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Up to approximately 4 years', 'description': 'DCR was assessed by investigators per mRECIST'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 4 years', 'description': 'DOR was assessed by investigators per mRECIST'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Up to approximately 4 years', 'description': 'PFS was assessed by investigators per mRECIST'}, {'measure': 'Time to progression (TTP)', 'timeFrame': 'Up to approximately 4 years', 'description': 'TTP was assessed by investigators per mRECIST'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of QL1706 in combination with bevacizumab and/or chemotherapy versus sintilimab in combination with bevacizumab as first-line treatment in patients with advanced hepatocellular carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects participate voluntarily and sign informed consent.\n2. Age ≥ 18 and ≤ 80 years old, male or female.\n3. Histological or cytological or clinical diagnosis of HCC\n4. Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment.\n5. No prior systemic therapy for HCC.\n6. Child-Pugh ≤7 , no history of hepatic encephalopathy.\n\nExclusion Criteria:\n\n1. Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.\n2. History of malignancy other than HCC within 5 years prior to the start of study treatment.\n3. History of liver transplantation, or planned to receive liver transplantation.\n4. Moderate or severe ascites with clinical symptoms that require drainage, uncontrolled or moderate or severe pleural and pericardical effusion.\n5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n6. Involvement of both the main portal vein and the left and right branches by portal vein tumor thrombus, or of both the main trunk and the superior mesenteric vein concurrently, or of inferior vena cava.'}, 'identificationModule': {'nctId': 'NCT05976568', 'briefTitle': 'A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase II/III, Randomized, Open-label, Multi-center Study to Evaluate the Efficacy and Safety of QL1706 in Combination With Bevacizumab and/or Chemotherapy Versus Sintilimab in Combination With Bevacizumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'QL1706-308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'QL1706 in combination with bevacizumab and chemotherapy', 'interventionNames': ['Drug: QL1706', 'Drug: Bevacizumab', 'Drug: Oxaliplatin injection', 'Drug: Capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'QL1706 in combination with bevacizumab', 'interventionNames': ['Drug: QL1706', 'Drug: Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'QL1706 in combination with chemotherapy', 'interventionNames': ['Drug: QL1706', 'Drug: Oxaliplatin injection', 'Drug: Capecitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 4', 'description': 'Sintilimab in combination with bevacizumab', 'interventionNames': ['Drug: Bevacizumab', 'Drug: Sintilimab']}], 'interventions': [{'name': 'QL1706', 'type': 'DRUG', 'description': '7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': '15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 4']}, {'name': 'Oxaliplatin injection', 'type': 'DRUG', 'description': '85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle', 'armGroupLabels': ['Arm 1', 'Arm 3']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': '1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle', 'armGroupLabels': ['Arm 1', 'Arm 3']}, {'name': 'Sintilimab', 'type': 'DRUG', 'description': '200 mg administered as IV infusion on Day 1 of each 21-day cycle', 'armGroupLabels': ['Arm 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '211199', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Shukui Qin', 'role': 'CONTACT'}], 'facility': 'Nanjing Tianyinshan Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Jia Fan', 'role': 'CONTACT'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jian Gao', 'role': 'CONTACT', 'email': 'jian7.gao@qilu-pharma.com', 'phone': '+8613304321400'}], 'overallOfficials': [{'name': 'Jia Fan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}, {'name': 'Shukui Qin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing Tianyinshan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}