Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 10:57 AM
Study NCT ID:
NCT05010434
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2021-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sintilimab and Bevacizumab Combined With Radiotherapy for 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': 'C000632826', 'term': 'sintilimab'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-18', 'studyFirstSubmitDate': '2021-08-14', 'studyFirstSubmitQcDate': '2021-08-17', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR (objective response rate)', 'timeFrame': 'through study completion, up to 2 year', 'description': 'the proportion of patients who have a partial or complete response to therapy.'}], 'secondaryOutcomes': [{'measure': 'PFS (progression-free survival)', 'timeFrame': 'through study completion, up to 2 year', 'description': 'defined as the time from receiving treatment until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.'}, {'measure': 'OS (overall survival)', 'timeFrame': 'through study completion, up to 2 year', 'description': 'defined as the time from receiving treatment until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.'}, {'measure': 'DCR (disease control rate)', 'timeFrame': 'through study completion, up to 2 year', 'description': 'the proportion of patients whose tumors have shrunk or been stable for a certain period of time, including cases of complete response (CR), partial response (PR), or stable disease (SD).'}, {'measure': 'LCR (local control rate)', 'timeFrame': 'through study completion, up to 2 year', 'description': 'the percentage of lesions with absence of recurrence within the high-dose region （80% isodose volume）'}, {'measure': 'Adverse effects', 'timeFrame': 'through study completion, up to 2 year', 'description': 'Adverse effects of sintilimab and bevacizumab combined with radiotherapy,number of participants with treatment-related adverse events as assessed by CTCAE v5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '38358542', 'type': 'DERIVED', 'citation': 'Zhu M, Liu Z, Chen S, Luo Z, Tu J, Qiao L, Wu J, Fan W, Peng Z. Sintilimab plus bevacizumab combined with radiotherapy as first-line treatment for hepatocellular carcinoma with portal vein tumor thrombus: A multicenter, single-arm, phase 2 study. Hepatology. 2024 Oct 1;80(4):807-815. doi: 10.1097/HEP.0000000000000776. Epub 2024 Feb 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate both the efficacy and safety of sintilimab combined with bevacizumab and radiotherapy in advanced hepatocellular carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18-75 years;\n2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n3. Treatment-naïve primary HCC (consistent with the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis (18)) or initial recurrent HCC after radical resection without any postoperative anti-cancer treatment;\n4. At least one measurable lesion in the liver on the basis of modified Response Evaluation Criteria in Solid Tumors (mRECIST);\n5. Presented with Cheng's type I/II/III PVTT;\n6. Largest tumor size ≤ 10 cm, number of tumors ≤ 3, and remnant liver volume ≥ 50%;\n7. Child-Pugh class A;\n8. Adequate hematological, liver, renal function:\n\n 1. hemoglobin concentration ≥ 90 g/L;\n 2. neutrophil count ≥ 1.5×109/L;\n 3. platelet count ≥ 60×109/L;\n 4. AST and ALT ≤ 3×upper limit of normal (ULN)\n 5. total bilirubin ≤ 1.5×ULN;\n 6. serum creatinine ≤ 1.5×ULN;\n 7. serum albumin concentration ≥ 30 g/L;\n9. Life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n1. Tumor invasion of the superior mesenteric vein or bile ducts;\n2. Infiltrative HCC;\n3. Allergic to research reagents;\n4. With other malignancies within 5 years;\n5. With poorly controlled hypertension;\n6. A past medical history of hepatic decompensation, such as hepatic encephalopathy, refractory ascites, and esophageal or gastric variceal bleeding;\n7. A history of autoimmune disease;\n8. Active infection requiring systemic treatments;\n9. Severe bleeding;\n10. With diseases needing daily non-steroidal anti-inflammatory drug (NSAID) therapy;\n11. With other severe comorbidities."}, 'identificationModule': {'nctId': 'NCT05010434', 'briefTitle': 'Sintilimab and Bevacizumab Combined With Radiotherapy for Advanced Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Sintilimab and Bevacizumab Combined With Radiotherapy in the Treatment of Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'SBRRHCC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sintilimab and Bevacizumab Combined with Radiotherapy', 'interventionNames': ['Drug: Sintilimab and Bevacizumab Combined with Radiotherapy']}], 'interventions': [{'name': 'Sintilimab and Bevacizumab Combined with Radiotherapy', 'type': 'DRUG', 'description': 'Before radiotherapy: Bevacizumab+Sintilizumab, Q3w, 2 cycles in total. Radiation therapy: 30-50Gy/10 fractions. After radiotherapy: Bevacizumab+Sintilizumab, Q3w until disease progression or toxicity is intolerable.', 'armGroupLabels': ['Sintilimab and Bevacizumab Combined with Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Innovent Biologics (Suzhou) Co. Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Zhen-Wei Peng', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}