Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-28 @ 6:08 AM
Study NCT ID:
NCT04967495
Status:
UNKNOWN
Last Update Posted:
2023-05-18
First Post:
2021-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TACE Plus Multikinase Inhibitor and I-125 Seeds Brachytherapy for HCC With Branch 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531958', 'term': 'lenvatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 171}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-01-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-16', 'studyFirstSubmitDate': '2021-07-08', 'studyFirstSubmitQcDate': '2021-07-08', 'lastUpdatePostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '2 years.', 'description': 'The time from date of randomization to death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Adverse events (AEs)', 'timeFrame': '2 years.', 'description': 'Number of patients with AE, treatment-related AE (TRAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0.'}, {'measure': 'Progression free survival (PFS) assessed by investigators according to Modified Response Evalutaion Criteria in Solid Tumors (mRECIST)', 'timeFrame': '2 years.', 'description': 'The time from date of randomization until the first occurrence of disease progression (PD) or death due to any cause, whichever occurs first.'}, {'measure': 'Objective response rate (ORR) assessed by investigators according to mRECIST', 'timeFrame': '2 years.', 'description': 'The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR).'}, {'measure': 'Disease control rate (DCR) assessed by investigators according to mRECIST', 'timeFrame': '2 years.', 'description': 'The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD).'}, {'measure': 'Duration of portal patency', 'timeFrame': '2 years.', 'description': 'The time from randomization until the date that complete portal vein occlusion was confirmed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma', 'Transarterial chemoembolization', 'Tyrosine kinase inhibitor', 'iodion-125 seed'], 'conditions': ['Hepatocellular Carcinoma Non-resectable']}, 'descriptionModule': {'briefSummary': 'This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization (TACE) combined with lenvatinib and iodion-125 seeds brachytherapy (TACE-Len-I) compared with TACE combined with lenvatinib (TACE-Len) for hepatocellular carcinoma (HCC) with portal vein branch tumor thrombus (branch PVTT).', 'detailedDescription': 'This is an single center, randomized controlled trial to evaluate the efficacy and safety of TACE-Len-I compared with TACE-Len for the treatment of HCC with branch PVTT.\n\n171 HCC patients with branch PVTT will be enrolled in this study. The Patients will be treated with TACE-Len-I or TACE-Len using an 2:1 randomization scheme.\n\nTACE will be performed for the patients after randomization. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \\< 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the TACE-Len-I arm, iodion-125 seeds will be implanted into the PVTT (according to the pre-operative planning) under CT guidance within 14 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between18 and 75 years.\n2. HCC confirmed by histopathology and/or cytology, or diagnosed clinically.\n3. Accompanied with tumor thrombus involving unilateral portal vein branch.\n4. Child-Pugh class A or B.\n5. Eastern Cooperative Group performance status (ECOG) score of 0-2.\n6. Serum bilirubin ≤ 51.3 μmol/L, albumin ≥ 28g/L, ALT and AST ≤ 5 times of the upper normal limit, and creatinine ≤ 20g/L.\n7. Prothrombin time prolonged for less than 4s or international normalized ratio \\< 1.7.\n8. Neutrophilic granulocyte count ≥ 1.5×10\\^9/L, platelet count ≥ 50×10\\^9/L, and hemoglobin level ≥ 85g/L;\n9. At least one measurable intrahepatic target lesion.\n10. Life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n1. Diffuse HCC.\n2. Extrahepatic metastasis.\n3. Tumor thrombus involving both the left and right branch of portal vein or main portal vein.\n4. Hepatic vein and/or vena cava invasion.\n5. History of organ or cells transplantation.\n6. Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy or systemic therapy.\n7. History of other malignancies.\n8. Serious medical comorbidities.\n9. Female patients who are pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT04967495', 'briefTitle': 'TACE Plus Multikinase Inhibitor and I-125 Seeds Brachytherapy for HCC With Branch PVTT', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'Transarterial Chemoembolization Combined With Lenvatinib and Iodion-125 Seeds Brachytherapy for Hepatocellular Carcinoma With Portal Vein Branch Tumor Thrombus: a Single Center, Prospective, Randomized Control Trail', 'orgStudyIdInfo': {'id': 'MIIR-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TACE-Len-I', 'description': 'TACE combined with lenvatinib and iodion-125 seeds brachytherapy', 'interventionNames': ['Procedure: TACE combined with lenvatinib and iodion-125 seeds brachytherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TACE-Len', 'description': 'TACE combined with lenvatinib', 'interventionNames': ['Procedure: TACE combined with lenvatinib']}], 'interventions': [{'name': 'TACE combined with lenvatinib and iodion-125 seeds brachytherapy', 'type': 'PROCEDURE', 'description': 'TACE will be performed for the patients after randomization. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \\< 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Iodion-125 seeds will be implanted into the PVTT under CT guidance within 14 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.', 'armGroupLabels': ['TACE-Len-I']}, {'name': 'TACE combined with lenvatinib', 'type': 'PROCEDURE', 'description': 'TACE will be performed for the patients after randomization and it can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \\< 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.', 'armGroupLabels': ['TACE-Len']}]}, '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'}], '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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}