Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2026-02-21 @ 9:48 PM
Study NCT ID:
NCT03642561
Status:
UNKNOWN
Last Update Posted:
2020-07-28
First Post:
2018-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'group 1 RFA alone group 2 TACE alone'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-25', 'studyFirstSubmitDate': '2018-08-08', 'studyFirstSubmitQcDate': '2018-08-20', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'up to 60 months'}], 'secondaryOutcomes': [{'measure': 'objective response rate', 'timeFrame': 'up to 60 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE', 'detailedDescription': 'The investigators conduct this clinical trial to evaluate the treatment outcome of RFA in HCC patients with tumor smaller than 7cm and tumor number less than five ,in comparison with TACE treatment.The primary outcome is overall survival.The secondary outcome is objective response rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* age 18 to 75 years ;\n* HCC confirmed by pathological or clinical diagnosis according to the American Association for the Study of Liver Diseases criteria ;\n* solitary HCC less than 7cm in diameter or multiple HCC lesions less 5\n* the absence of portal/hepatic vein invasion, lymph node involvement and extrahepatic metastases;\n* lesions visible on ultrasound with a safe path between the lesion and skin;\n* an Eastern Cooperative Oncology Group performance status of 0-1;\n* Child-Pugh class A or B cirrhosis.\n\nThe exclusion criteria :\n\n* received any other previous treatment for HCC;\n* severe coagulation disorders;\n* evidence of hepatic decompensation including hepatic encephalopathy, ascites as well as esophageal or gastric variceal bleeding;\n* presence of serious medical comorbidities, including serious dysfunction of the heart or kidney ;\n* currently had other malignancies in addition to HCC.'}, 'identificationModule': {'nctId': 'NCT03642561', 'briefTitle': 'Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Liver Cancer Institiute ,Fudan University', 'orgStudyIdInfo': {'id': 'LC-RFA vs.TACE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RFA group', 'description': 'Patients in RFA group will accept RFA treatment', 'interventionNames': ['Device: radiotherapy ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TACE group', 'description': 'Patients in TACE group will accept TACE treatment', 'interventionNames': ['Device: transarterial chemoembolization(TACE)']}], 'interventions': [{'name': 'radiotherapy ablation', 'type': 'DEVICE', 'description': 'We using Cool Tip system or RITA system to perform RFA', 'armGroupLabels': ['RFA group']}, {'name': 'transarterial chemoembolization(TACE)', 'type': 'DEVICE', 'description': 'TACE treatment is a first line treatment for BCLC stage B HCC', 'armGroupLabels': ['TACE group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Yin, doctor', 'role': 'CONTACT', 'email': 'yin.xin@zs-hospital.sh.cn'}, {'name': 'zhenggang Ren, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xin Yin, doctor', 'role': 'CONTACT', 'email': 'yin.xin@zs-hospital.sh.cn', 'phone': '+86-21-64041990'}], 'overallOfficials': [{'name': 'Zhenggang Ren, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to make IPDavailable to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'zhongshan hospital', 'investigatorFullName': 'Zheng-Gang Ren', 'investigatorAffiliation': 'Fudan University'}}}}