Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:35 PM
Study NCT ID:
NCT07380633
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-02
First Post:
2026-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Toripalimab Plus Bevacizumab Combined Three Intra-arterial Therapies (TACE, HAIC, or TACE-HAIC) for Unresectable Hepatocellular Carcinoma: a Phase 2, Multicenter Randomised Non-comparative Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The TACE was performed using 30 mg/m2 of epirubicin, 300mg/m2 carb mixed with 2-5 mL lipiodol, followed by pure lipiodol. The HAIC regimen at the following dosage: 85 mg/m2 of oxaliplatin infusion for 2 hours; leucovorin, 400 mg/m2 infusion for 2 hours; 400 mg/m2 of 5-FU bolus; and 1200mg/m2 of continuous 5-FU infusion for 23 hours, respectively. TACE-HAIC was performed TACE following by HAIC. Repeated transarterial therapy was performed at intervals of 3-4 weeks. Toripalimab was adminstated at 240mg and bevacizumab was adminstated at 15mg/kg on next day after transarterial therapy.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-25', 'studyFirstSubmitDate': '2026-01-25', 'studyFirstSubmitQcDate': '2026-01-25', 'lastUpdatePostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '12-Month PFS Rate (Intention-to-Treat)', 'timeFrame': '12 months', 'description': 'This measure reports the proportion of all randomized patients (ITT population) who are progression-free at 12 months post-randomization.'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': '12 months', 'description': 'overall survival time after randomisation, taking into account all deaths'}, {'measure': 'PFS', 'timeFrame': '12 months', 'description': 'progression free survival time after randomisation, taking into account all deaths'}, {'measure': 'ORR', 'timeFrame': '12 months', 'description': 'objective response rate assessed by RECIST 1.1'}, {'measure': 'adverse event', 'timeFrame': '12 months', 'description': 'adverse event was assessed by NCI-CTC 5.0 to evaluate safety'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma (HCC)']}, 'descriptionModule': {'briefSummary': 'Toripalimab and bevacizumab (T-B) was approve for unresectable hepatocellular carcinoma (uHCC). Transartial therapies, including transarterial chemoembolization (TACE), hepatic artery infusion chemotherapy (HAIC), and TACE-HAIC are commonly used for uHCC. Increasing evidence showed that combined systemic therapy and transarterial therapy will improve the response rate for those patients. It is unknown whether which tranarterial therapy will proved favorable efficiency when combined T-B. This phase 2 clinical trial aims to investigate the short outcome of T-B with three distinct transarterial therapies for uHCC.', 'detailedDescription': 'Toripalimab in combination with bevacizumab (T-B) has been approved for the treatment of unresectable hepatocellular carcinoma (uHCC). Transarterial therapies-including transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), and combined TACE-HAIC-are widely used in the management of uHCC. Growing evidence suggests that combining systemic therapy with transarterial approaches can enhance response rates in these patients. However, it remains unclear which transarterial modality, when used alongside T-B, offers the most favorable efficacy. This phase 2 clinical trial is designed to evaluate and compare the short-term outcomes of T-B in combination with three different transarterial therapies for uHCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (a) patients were diagnozied with unresectable HCC, (b) Child-Pugh A or B liver function; (d) Eastern Cooperative Oncology Group (ECOG) performance status 0-1; (e) adequate hematologic blood counts (white blood cell count \\>3ⅹ109/L, absolute neutrophil count \\>1.5ⅹ109/L, platelet count \\>10ⅹ109/L, hemoglobin concentration \\>85 g/L);\n\nExclusion Criteria:\n\n* (a) severe underlying cardiac, pulmonary, or renal diseases; (b) history of a second primary malignant tumor; (c) contraindication to either toripalimab and bevacizumab.'}, 'identificationModule': {'nctId': 'NCT07380633', 'briefTitle': 'Toripalimab Plus Bevacizumab Combined Three Intra-arterial Therapies (TACE, HAIC, or TACE-HAIC) for Unresectable Hepatocellular Carcinoma: a Phase 2, Multicenter Randomised Non-comparative Trial', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Toripalimab Plus Bevacizumab Combined Three Intra-arterial Therapies (Transarterial Chemoembolization, Hepatic Artery Infusion Chemotherapy, or Transarterial Chemoembolization Plus Hepatic Artery Infusion Chemotherapy) for Unresectable Hepatocellular Carcinoma: a Phase 2, Multicenter Randomised Non-comparative Trial', 'orgStudyIdInfo': {'id': 'B2025-900-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TACE-HAIC+T-B', 'description': 'Transartery chemoembolization and hepatic artery infusion of FOLFOX, simultaneously followed by toripalimab of 240mg plus bevacizumab (15mg/kg)', 'interventionNames': ['Drug: TACE-HAIC+T-B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TACE+T-B', 'description': 'Transartery chemoembolization followed by toripalimab of 240mg plus bevacizumab (15mg/kg)', 'interventionNames': ['Drug: TACE+T-B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HAIC+T-B', 'description': 'hepatic artery infusion of FOLFOX regimen followed by toripalimab of 240mg plus bevacizumab (15mg/kg)', 'interventionNames': ['Drug: HAIC+T-B']}], 'interventions': [{'name': 'TACE-HAIC+T-B', 'type': 'DRUG', 'description': 'Transartery chemoembolization and hepatic artery infusion of FOLFOX, simultaneously followed by toripalimab of 240mg plus bevacizumab (15mg/kg)', 'armGroupLabels': ['TACE-HAIC+T-B']}, {'name': 'HAIC+T-B', 'type': 'DRUG', 'description': 'FOLFOX-based HAIC regimen followed by toripalimab of 240mg plus bevacizumab', 'armGroupLabels': ['HAIC+T-B']}, {'name': 'TACE+T-B', 'type': 'DRUG', 'description': 'TACE was performed using 30 mg/m2 of epirubicin, 300mg/m2 carb mixed with 2-5 mL lipiodol, followed by pure lipiodol, followed by toripalimab was adminstated at 240mg and bevacizumab was adminstated at 15mg/kg.', 'armGroupLabels': ['TACE+T-B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yunfei Yuan', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}