Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-25 @ 12:59 PM
Study NCT ID:
NCT04911959
Status:
UNKNOWN
Last Update Posted:
2023-02-06
First Post:
2021-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of TACE Combined With Lenvatinib to Prevent Postoperative Recurrence in Patients With MVI Positive HCC
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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-02', 'studyFirstSubmitDate': '2021-01-18', 'studyFirstSubmitQcDate': '2021-06-02', 'lastUpdatePostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 8 weeks', 'description': 'To evaluate the safety of TACE combined with lenvatinib treatment in preventing postoperative recurrence in patients with MVI-positive HCC'}, {'measure': 'Changes in tumor volume', 'timeFrame': 'Up to 8 weeks', 'description': 'To evaluate the effectiveness of TACE combined with lenvatinib treatment in preventing postoperative recurrence in patients with MVI-positive HCC'}, {'measure': 'Recurrence-free survival (RFS) evaluation', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'To evaluate the recurrence-free survival of patients with MVI-positive HCC after TACE combined with lenvatinib treatment'}], 'secondaryOutcomes': [{'measure': 'Disease recurrence time evaluation', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'To evaluate the tumor recurrence time of patients with MVI-positive HCC after TACE combined with lenvatinib treatment'}, {'measure': 'Overall survival ( OS) evaluation', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Overall survival time as assessed by IRC'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TACE', 'Hepatocellular Carcinoma', 'MVI', 'Prognosis', 'Lenvatinib'], 'conditions': ['Hepatocellular Carcinoma', 'Lenvatinib']}, 'descriptionModule': {'briefSummary': 'single-center clinical trial studies have verified the safety and effectiveness of transcatheter arterial chemoembolization (TACE) combined with lenvatinib in preventing postoperative recurrence of microvascular invasion (MVI) positive HCC patients. Explore a new clinical first-line treatment plan for patients with liver cancer microvascular invasion after surgery.', 'detailedDescription': 'Focusing on the current status of clinical treatment of microvascular invasion (MVI) positive postoperative hepatocellular carcinoma (HCC) , single-center clinical trial studies have verified the safety and effectiveness of transcatheter arterial chemoembolization (TACE) combined with lenvatinib in preventing postoperative recurrence of MVI-positive HCC patients. Explore a new clinical first-line treatment plan for patients with liver cancer microvascular invasion after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Radical hepatocellular carcinoma was treated 4 weeks (±1 week) ago, and the pathological diagnosis was HCC after surgery, and MVI was positive\n* Child-Pugh score ≤9 points (Child-Pugh A-B), PS score 0-2 points, BCLC stage A-B\n* The main portal vein is not completely obstructed, or although it is completely obstructed, the compensatory collateral branches of the portal vein are abundant or the portal vein blood flow can be restored by implanting the portal vein stent\n* With sufficient organ and bone marrow function, the laboratory test values within 7 days before enrollment meet the requirements\n* Physical fitness score ECOG 0～2\n* Expected survival\\> 3 months\n* No other systemic malignancies\n* Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age must take effective contraceptive measures throughout the treatment period and 6 months after the treatment period\n* Subjects have informed consent, understand and are willing to cooperate with the trial protocol, and sign relevant documents\n\nExclusion Criteria:\n\n* Histology includes fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.\n* Severe liver dysfunction (Child-Pugh C), including jaundice, hepatic encephalopathy, refractory ascites, hepatorenal syndrome, or a history of liver transplantation\n* The main portal vein is completely blocked, and the formation of collateral vessels is small'}, 'identificationModule': {'nctId': 'NCT04911959', 'briefTitle': 'Study of TACE Combined With Lenvatinib to Prevent Postoperative Recurrence in Patients With MVI Positive HCC', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Study on the Safety and Effectiveness of Transcatheter Arterial Chemoembolization (TACE) Combined With Lenvatinib to Prevent Postoperative Recurrence in Patients With Microvascular Invasion (MVI) Positive Hepatocellular Carcinoma (HCC)', 'orgStudyIdInfo': {'id': 'yan2020-629'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'patients receive transcatheter arterial chemoembolization (TACE) only.', 'interventionNames': ['Procedure: TACE']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'patients receive transcatheter arterial chemoembolization (TACE) and lenvatinib 8mg per day.', 'interventionNames': ['Drug: Lenvatinib', 'Procedure: TACE']}], 'interventions': [{'name': 'Lenvatinib', 'type': 'DRUG', 'description': 'Lenvatinib is taken orally.', 'armGroupLabels': ['Intervention group']}, {'name': 'TACE', 'type': 'PROCEDURE', 'otherNames': ['Transcatheter Arterial Chemoembolization'], 'description': 'TACE treatment once.', 'armGroupLabels': ['Intervention group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'None Selected', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weilin Wang, M.D.', 'role': 'CONTACT', 'email': 'wam@zju.edu.cn', 'phone': '+86 0571 87783820'}], 'facility': 'Weilin Wang', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuan Ding, M.D.', 'role': 'CONTACT', 'email': 'dingyuan@zju.edu', 'phone': '+86 18858101960'}, {'name': 'Weilin Wang, M.D.', 'role': 'CONTACT', 'email': 'wam@zju.edu.cn', 'phone': '+86 0571 87783820'}], 'facility': 'The Second Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Weilin Wang', 'role': 'CONTACT', 'email': 'wam@zju.edu.cn', 'phone': '+8657187783820'}, {'name': 'Yuan Ding', 'role': 'CONTACT', 'email': 'dingyuan@zju.edu', 'phone': '+8618858101960'}], 'overallOfficials': [{'name': 'Zhongquan Sun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}