Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 1:24 PM
Study NCT ID:
NCT00730860
Status:
UNKNOWN
Last Update Posted:
2017-03-28
First Post:
2008-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation (RFA) Associated With Postoperative TACE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-27', 'studyFirstSubmitDate': '2008-08-06', 'studyFirstSubmitQcDate': '2008-08-06', 'lastUpdatePostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease free survival', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['radiofrequency ablation', 'Cancer of Liver', 'postoperative', 'transhepatic arterial chemoembolization', 'prospective'], 'conditions': ['Cancer of Liver']}, 'descriptionModule': {'briefSummary': 'A RCT was conducted to elucidate whether the treatment outcome of HCC could be improved by RFA associated with postoperative TACE.', 'detailedDescription': 'A randomized study was conducted to elucidate whether the outcome of hepatocellular carcinoma could be improved by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with hepatocellular,confirmed by pathological examination\n* patients with a live function test showed Child A or B\n* Indocyanine green test showed less than 30％ after 15min,and the patients showed a tolerance of RFA and TACE\n* Tumor stage is early period(according to Milan Standard),that is,the diameter of single node should be less than 5cm；the node of tumor should be less than 3 and the diameter less than 3cm.\n* without metastasis in lymphnode or other organs\n* written consent inform assigned\n\nExclusion Criteria:\n\n* preoperative examination showed malignant thrombosis in the first class branch of portal vein or hepatic vein or vena cava\n* metastatic cancer of liver\n* patients with a poor tolerance of RFA and TACE\n* patients received other therapies.'}, 'identificationModule': {'nctId': 'NCT00730860', 'briefTitle': 'Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation (RFA) Associated With Postoperative TACE', 'organization': {'class': 'OTHER', 'fullName': 'Southwest Hospital, China'}, 'officialTitle': 'Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation Associated With Postoperative Transhepatic Arterial Chemoembolization--a Prospective Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'SWHB002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RFA+TACE', 'description': 'treatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization', 'interventionNames': ['Procedure: radiofrequency ablation associated with TACE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RFA only', 'description': 'treatment of hepatocellular carcinoma by radiofrequency ablation only', 'interventionNames': ['Procedure: radiofrequency ablation only']}], 'interventions': [{'name': 'radiofrequency ablation associated with TACE', 'type': 'PROCEDURE', 'otherNames': ['Group A'], 'description': 'treatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization', 'armGroupLabels': ['RFA+TACE']}, {'name': 'radiofrequency ablation only', 'type': 'PROCEDURE', 'otherNames': ['Group B'], 'description': 'treatment of hepatocellular carcinoma by radiofrequency ablation only', 'armGroupLabels': ['RFA only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400038', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ma Kuansheng, Ph.D', 'role': 'CONTACT', 'email': 'xiaobinf@medmail.com.cn', 'phone': '86-23-68765297'}, {'name': 'Feng Xiaobin, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of hepatobiliary surgery', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Feng Xiaobin, M.D', 'role': 'CONTACT', 'email': 'fengxiaobin200708@yahoo.com.cn', 'phone': '+86-23-68765297'}], 'overallOfficials': [{'name': 'Ma Kuansheng, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of hepatobiliary surgery,Southwest Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Science, Technology and Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Xiaobin Feng', 'investigatorFullName': 'feng xiaobin', 'investigatorAffiliation': 'Southwest Hospital, China'}}}}