Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-05 @ 5:06 PM
Study NCT ID:
NCT03636620
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2018-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TACE Combined With RFA/MV Treatment in Hepatocellular Carcinoma Beyond Milan Criterial
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': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'TACE vs.TACE+RFA'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-15', 'studyFirstSubmitDate': '2018-08-08', 'studyFirstSubmitQcDate': '2018-08-15', 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'up to 46 months'}], 'secondaryOutcomes': [{'measure': 'objective response rate', 'timeFrame': 'up to 46 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study was designed to evaluate the effectiveness of radiofrequency /microwave ablation in patients with hepatocellular carcinoma beyond Milan Criteria.', 'detailedDescription': 'The aim of this study is to included 120 patients with intermediate stage hepatocellular carcinoma beyond Milan criteria .These patients were randomizedly allocated to TACE treatment group or TACE+RFA/MV .The treatment effectiveness, local tumor control and survival outcome between the two groups were compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diganosed with hepatocellualr carcinoma beyond Milan criteria\n* the presence of a single HCC tumor ≤7 cm in diameter, or multi-nodular HCC tumors (n ≤ 5) small than 7 cm in diameter;\n* Child-Pugh A or B\n* ECOG score 0-1;\n* prothrombin time ≤16 s;\n* white cell count ≥3,000/mm3, platelet count ≥40 x 109/L;Hb≥8.5 g/d; ALT/AST≤5×ULN;TB≤3mg/dl;alb≥2.8 g/dl ;Scr ≤2mg/dl\n\nExclusion Criteria:\n\n* expected survival time \\< 12 months before random assignment;\n* received anticancer surgery or procedure within one month before assignment;\n* concomitant use of any other anticancer therapy(except immunotherapy and herbal medicine ) ;\n* existence of portal of hepatic vein invation or extrahepatic metastases;existence of active infection ;\n* upper gastrointestinal hemorrhage within one month ; .other serious illness or medical condition.'}, 'identificationModule': {'nctId': 'NCT03636620', 'acronym': 'TACE+RFA', 'briefTitle': 'TACE Combined With RFA/MV Treatment in Hepatocellular Carcinoma Beyond Milan Criterial', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Clinical Trial of Transcatheter Arterial Chemoembolization Combined With Radiofrequency/Microwave Ablation in Hepatocellular Carcinoma Beyond Milan Criterial', 'orgStudyIdInfo': {'id': 'LC-TACE+RFA/MV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TACE group', 'description': 'Transcatheter arterial chemoembolization', 'interventionNames': ['Device: Transcatheter arterial chemoembolization']}, {'type': 'EXPERIMENTAL', 'label': 'TACE+RFA/MV group', 'description': 'Transcatheter arterial chemoembolization and radiofrequency /microwave ablation', 'interventionNames': ['Device: Transcatheter arterial chemoembolization', 'Device: radiofrequency ablation/microwave ablation']}], 'interventions': [{'name': 'Transcatheter arterial chemoembolization', 'type': 'DEVICE', 'otherNames': ['TACE'], 'description': 'Transcatheter arterial chemoembolization', 'armGroupLabels': ['TACE group', 'TACE+RFA/MV group']}, {'name': 'radiofrequency ablation/microwave ablation', 'type': 'DEVICE', 'otherNames': ['RFA/MW'], 'description': 'radiofrequency ablation/microwave ablation', 'armGroupLabels': ['TACE+RFA/MV group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'liver cancer institute ,Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'zheng-gang Ren, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no plan to make individual paticipant data available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Zheng-Gang Ren', 'investigatorAffiliation': 'Fudan University'}}}}