Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-25 @ 2:56 PM
Study NCT ID:
NCT06609850
Status:
RECRUITING
Last Update Posted:
2024-12-03
First Post:
2024-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-01', 'studyFirstSubmitDate': '2024-09-20', 'studyFirstSubmitQcDate': '2024-09-20', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': '24 months', 'description': 'PFS is defined as the time from the date of inclusion to the date of the first objectively documented tumor progression or death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '36 month', 'description': 'OS is the length of time from the date of inclusion until death from any cause.'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': '12 months', 'description': 'ORR, as determined based on tumor response according to mRECIST, is defined as partial response and complete response.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lenvatinb', 'Hepatocellular carcinoma', 'Microwave ablation', 'Radiofrequency ablation', 'Cryoablation'], 'conditions': ['Recurrent Hepatocellular Carcinoma', 'Lenvatinib', 'Local Therapy', 'Ablation', 'Systemic Therapy']}, 'descriptionModule': {'briefSummary': 'Studies have shown that combination therapy of TACE with Lenvatinib could achieve better survival outcomes than TACE alone for hepatocellular carcinoma (HCC) at BCLC B stage. However, whether patients could benefit from the ablation for intermediate recurrent HCC (RHCC) is still need high quality clinical evidence. This study is to evaluate the efficacy of ablation combined with TACE and Lenvatinib for the intermediate-stage RHCC.', 'detailedDescription': 'The evidence of ablation combined transarterial chemoembolisation (TACE) and Lenvatinib for intermediate-stage recurrent hepatocellular carcinoma (RHCC) is limited. Patient responses to this treatment vary because of the heterogeneous nature of RHCC. Thus, it is important to identify patients who are most likely to benefit from this three regimes therapy. The aim of this study is to comparison of TACE-Lenvatinib with TACE-Lenvatinib-ablation for intermediate RHCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-75 years;\n2. RHCC diagnosed by imaging;\n3. intermediate-stage RHCC (two to three lesions which at least one was \\>3 cm in size or more than three tumors);\n4. the tumor number was no more than six, and the maximum tumor diameter was ≤5 cm;\n5. absence of extrahepatic metastasis or macrovascular invasion;\n6. Child-Pugh class A or B;\n7. TACE as initial treatment after tumor recurrence and showed no tumor progression after TACE.\n8. life expectance \\>3 months;\n\nExclusion Criteria:\n\n1. under 18 years or over 75 years of age;\n2. primary intermediate-stage HCC;\n3. RHCC with more than six tumors, or single RHCC\n\n(5) RHCC \\>5cm; (6) extrahepatic metastasis; (7) macrovascular tumor thrombus;'}, 'identificationModule': {'nctId': 'NCT06609850', 'briefTitle': 'The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma: a Multicenter Randomized Control Study', 'orgStudyIdInfo': {'id': 'Liver Projiect 10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TACE plus Lenvatinib', 'description': 'TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure.\n\nLenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight \\<60 kg) orally once a day )', 'interventionNames': ['Procedure: TACE', 'Drug: Lenvatinb']}, {'type': 'EXPERIMENTAL', 'label': 'TACE plus Lenvatinib and ablation', 'description': 'TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure.\n\nLenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight \\<60 kg) orally once a day ) Ablation (radiofrequency ablation, microwave ablation, cryoablation), ablation followed TACE within 6-8 weeks and Lenvatinib continued. Percutaneous ablation was performed by ultrasound or CT. The ablation success is evaluated by achieving an ablative margin of 0.5 cm or more than the tumor size.', 'interventionNames': ['Procedure: TACE', 'Procedure: Ablation', 'Drug: Lenvatinb']}], 'interventions': [{'name': 'TACE', 'type': 'PROCEDURE', 'description': 'TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure.', 'armGroupLabels': ['TACE plus Lenvatinib', 'TACE plus Lenvatinib and ablation']}, {'name': 'Ablation', 'type': 'PROCEDURE', 'description': 'Ablation (radiofrequency ablation, microwave ablation, cryoablation), ablation followed TACE within 6-8 weeks and Lenvatinib continued. Percutaneous ablation was performed by ultrasound or CT. The ablation success is evaluated by achieving an ablative margin of 0.5 cm or more than the tumor size.', 'armGroupLabels': ['TACE plus Lenvatinib and ablation']}, {'name': 'Lenvatinb', 'type': 'DRUG', 'description': 'Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight \\<60 kg) orally once a day )', 'armGroupLabels': ['TACE plus Lenvatinib', 'TACE plus Lenvatinib and ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'None Selected', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qunfang Zhou', 'role': 'CONTACT', 'email': 'zhouqun988509@163.com', 'phone': '8619868000115'}, {'name': 'Feng Duan', 'role': 'CONTACT', 'email': 'duanfeng@vip.sina.com', 'phone': '8613910984586'}], 'facility': 'Chinese PLA General hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Qunfang Zhou', 'role': 'CONTACT', 'email': 'zhouqun988509@163.com', 'phone': '86 19868000115'}, {'name': 'Feng Duan', 'role': 'CONTACT', 'email': 'duanfeng@vip.sina.com', 'phone': '86 13910984586'}], 'overallOfficials': [{'name': 'Feng Duan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Zhou Qunfang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}