Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2026-01-01 @ 9:47 AM
Study NCT ID:
NCT06371157
Status:
RECRUITING
Last Update Posted:
2025-03-12
First Post:
2024-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic 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': 'C531958', 'term': 'lenvatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 469}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-05-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2024-04-15', 'studyFirstSubmitQcDate': '2024-04-15', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'timeFrame': 'Up to approximately 2 years', 'description': 'PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by blinded independent central review (BICR).'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 2 years', 'description': 'OS is defined as the time from randomization to death due to any cause.'}, {'measure': 'PFS per RECIST 1.1', 'timeFrame': 'Up to approximately 2 years', 'description': 'Assessed by investigators'}, {'measure': 'Objective Response Rate (ORR) per RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Assessed by BICR and investigators'}, {'measure': 'Duration of Response (DOR) per RECIST 1.1 and mRECIST', 'timeFrame': 'Up to approximately 2 years', 'description': 'Assessed by BICR and investigators'}, {'measure': 'Disease Control Rate (DCR) per RECIST 1.1 and mRECIST', 'timeFrame': 'Up to approximately 2 years', 'description': 'Assessed by BICR and investigators'}, {'measure': 'Time to Response (TTR) per RECIST 1.1 and mRECIST', 'timeFrame': 'Up to approximately 2 years', 'description': 'Assessed by BICR and investigators'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Has a diagnosis of HCC confirmed by histology/cytology，or meet the clinical diagnostic criteria of the American Association for the Study of Liver Diseases (AASLD)\n2. No evidence of metastasis\n3. Not amenable to curative surgery or transplantation or curative ablation but amenable to TACE\n4. Child Pugh score class A\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment\n6. Measurable disease by RECIST 1.1\n7. Adequate organ function\n\nExclusion Criteria:\n\n1. History of liver transplantation\n2. History of hepatic encephalopathy\n3. Uncontrolled arterial hypertension\n4. Deep venous thrombosis within 3 months before first treatment\n5. Bleeding events within the last 6 months\n6. Co-infection with HBV and HCV'}, 'identificationModule': {'nctId': 'NCT06371157', 'briefTitle': 'A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akeso'}, 'officialTitle': 'A Phase III, Randomized, Double-blinded, Multicenter Study of Cadonilimab (AK104) + Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'AK104-308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'AK104+ Lenvatinib in Combination With Transarterial Chemoembolization (TACE)', 'interventionNames': ['Drug: AK104', 'Drug: Lenvatinib', 'Procedure: TACE']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm B', 'description': 'Placebo for AK104 + Placebo for Lenvatinib in Combination With TACE', 'interventionNames': ['Procedure: TACE', 'Other: Placebo for AK104', 'Other: Placebo for Lenvatinib']}, {'type': 'OTHER', 'label': 'Arm C', 'description': 'AK104 + Placebo for Lenvatinib in Combination With TACE', 'interventionNames': ['Drug: AK104', 'Procedure: TACE', 'Other: Placebo for Lenvatinib']}], 'interventions': [{'name': 'AK104', 'type': 'DRUG', 'description': 'intravenous', 'armGroupLabels': ['Arm A', 'Arm C']}, {'name': 'Lenvatinib', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['Arm A']}, {'name': 'TACE', 'type': 'PROCEDURE', 'description': 'TACE (chemo and embolic agent injection into the hepatic artery)', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C']}, {'name': 'Placebo for AK104', 'type': 'OTHER', 'description': 'intravenous', 'armGroupLabels': ['Arm B']}, {'name': 'Placebo for Lenvatinib', 'type': 'OTHER', 'description': 'oral', 'armGroupLabels': ['Arm B', 'Arm C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450004', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hailiang Li', 'role': 'CONTACT'}], 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '410006', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shanzhi Gu', 'role': 'CONTACT'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gaojun Teng', 'role': 'CONTACT'}], 'facility': 'Zhongda Hospital Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '310005', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guoliang Shao', 'role': 'CONTACT'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Ting Liu', 'role': 'CONTACT', 'email': 'clinicaltrials@akesobio.com', 'phone': '+86 (0760) 8987 3999'}], 'overallOfficials': [{'name': 'Guoliang Shao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang Cancer Hospital'}, {'name': 'Gaojun Teng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongda Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akeso', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}