Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-02-21 @ 9:06 PM
Study NCT ID:
NCT06492395
Status:
RECRUITING
Last Update Posted:
2025-01-29
First Post:
2024-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 178}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-26', 'studyFirstSubmitDate': '2024-07-02', 'studyFirstSubmitQcDate': '2024-07-02', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression (TTP)', 'timeFrame': '2 years', 'description': 'The time from date of randomization until the first occurrence of disease progression (according to mRECIST).'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': '2 years', 'description': 'The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST.'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': '2 years', 'description': 'The proportion of patients with the best response of CR, PR, or stable disease (SD) according to mRECIST.'}, {'measure': 'Overall survival (OS)', 'timeFrame': '3 years', 'description': 'The time from date of randomization to death due to any cause.'}, {'measure': 'Adverse Events (AEs)', 'timeFrame': '3 years.', 'description': 'Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hepatocellular carcinoma', 'lenvatinib', 'transarterial chemoembolization', 'drug-eluting bead', 'hepatic arterial infusion chemotherapy', 'portal vein tumor thrombosis'], 'conditions': ['Hepatocellular Carcinoma Non-resectable']}, 'descriptionModule': {'briefSummary': 'This study is conducted to evaluate the efficacy and safety of lenvatinib plus transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (Len+DEB-TACE+HAIC) versus lenvatinib plus DEB-TACE (Len+DEB-TACE) for large hepatocellular carcinoma (\\> 7cm) with portal vein tumor thrombosis (PVTT).', 'detailedDescription': 'This is a multicenter, prospective and randomized study to evaluate the efficacy and safety of Len+DEB-TACE+HAIC compared with Len+DEB-TACE for unresectable large HCC (\\>7cm) with PVTT.\n\n178 patients with large HCC (\\> 7cm) and PVTT will be enrolled in this study. The patients will receive either Len+DEB-TACE+HAIC or Len+DEB-TACE using an 1:1 randomization scheme. In the Len+DEB-TACE+HAIC arm, the microcatheter will be reserved at the main hepatic tumor-feeding artery after DEB-TACE and chemotherapy drugs (oxaliplatin, fluorouracil and leucovorin; FOLFOX-based regimen) will be intra-arterially administered though the microcatheter. DEB-TACE+HAIC treatments can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In the Len+DEB-TACE arm, patients will be treated with DEB-TACE alone. TACE treatment can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In both arms, lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \\<60kg) P.O. qd will be started within 7 days after the first DEB-TACE+HAIC/DEB-TACE.\n\nThe primary end point of this study is time to progression (TTP). The secondary endpoints are tumor response (objective response rate and disease control rate), overall survival (OS), and adverse events (AEs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a confirmed diagnosis of HCC\n* the largest intrahepatic lesion \\>7 cm\n* presence of PVTT on imaging\n* tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment\n* Eastern Cooperative Oncology Group performance status ≤1\n* Child-Pugh class A/B\n* adequate hematologic and organ function, with leukocyte count\\>3.0×10\\^9/L, neutrophil count\\>1.5×10\\^9/L, platelet count≥75×10\\^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal\n* life expectancy of at least 3 months\n\nExclusion Criteria:\n\n* Diffuse HCC\n* accompanied with vena cava tumor thrombus\n* central nervous system involvement\n* previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy\n* organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment\n* history of other malignancies\n* uncontrollable infection\n* history of HIV\n* history of organ or cells transplantation\n* prothrombin time prolongation \\>4 s'}, 'identificationModule': {'nctId': 'NCT06492395', 'briefTitle': 'Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'A Multicentre, Randomised Controlled Study of Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy With FOLFOX Regimen Versus Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization for Hepatocellular Carcinoma Larger Than 7 cm With Portal Vein Tumor Thrombosis', 'orgStudyIdInfo': {'id': 'MIIR-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Len+DEB-TACE+HAIC', 'description': 'Patients will receive the combination treatment of Len+DEB-TACE+HAIC.', 'interventionNames': ['Combination Product: Len+DEB-TACE+HAIC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Len+DEB-TACE', 'description': 'Patients will receive the combination treatment of Len+DEB-TACE.', 'interventionNames': ['Combination Product: Len+DEB-TACE']}], 'interventions': [{'name': 'Len+DEB-TACE+HAIC', 'type': 'COMBINATION_PRODUCT', 'description': 'For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session.\n\nAfter each chemoembolization, the microcatheter is reserved at the main hepatic tumor-feeding artery. The FOLFOX-based regimen is intra-arterially administered.\n\nDuring follow-up, the treatment of DEB-TACE and/or HAIC will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination.\n\nLenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \\<60kg) P.O. qd will be started with 7 days after the first DEB-TACE+HAIC.', 'armGroupLabels': ['Len+DEB-TACE+HAIC']}, {'name': 'Len+DEB-TACE', 'type': 'COMBINATION_PRODUCT', 'description': 'For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. During follow-up, the treatment of DEB-TACE will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination.\n\nLenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \\<60kg) P.O. qd will be started with 7 days after the first DEB-TACE+HAIC.', 'armGroupLabels': ['Len+DEB-TACE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510260', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mingyue Cai, Dr.', 'role': 'CONTACT', 'email': 'cai020@yeah.net', 'phone': '+86-20-34156205'}, {'name': 'Kangshun Zhu, Dr.', 'role': 'CONTACT', 'email': 'zhksh010@163.com', 'phone': '+86-20-34156205'}, {'name': 'Kangshun Zhu, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Mingyue Cai, Dr.', 'role': 'CONTACT', 'email': 'cai020@yeah.net', 'phone': '+86-20-34156205'}, {'name': 'Kangshun Zhu, Dr.', 'role': 'CONTACT', 'email': 'zhksh010@163.com', 'phone': '+86-20-34156205'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}