Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-02-22 @ 5:22 PM
Study NCT ID:
NCT00479050
Status:
COMPLETED
Last Update Posted:
2007-05-25
First Post:
2007-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 291}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-05-24', 'studyFirstSubmitDate': '2007-05-24', 'studyFirstSubmitQcDate': '2007-05-24', 'lastUpdatePostDateStruct': {'date': '2007-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'tumor response', 'timeFrame': '1-6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatocellular carcinoma,treatment'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '18398079', 'type': 'DERIVED', 'citation': 'Cheng BQ, Jia CQ, Liu CT, Fan W, Wang QL, Zhang ZL, Yi CH. Chemoembolization combined with radiofrequency ablation for patients with hepatocellular carcinoma larger than 3 cm: a randomized controlled trial. JAMA. 2008 Apr 9;299(14):1669-77. doi: 10.1001/jama.299.14.1669.', 'retractions': [{'pmid': '19380477', 'source': 'DeAngelis CD, Fontanarosa PB. JAMA. 2009 May 13;301(18):1931'}]}]}, 'descriptionModule': {'briefSummary': 'Combined the chemoembolization and Radiofrequency ablation for the hepatocellular carcinoma greater than 3 cm,the ablation volume of coagulation necrosis can be significantly increased,which may be enable effective treatment of patients with HCC greater than 3 cm.', 'detailedDescription': 'To assess whether the effectiveness of a combination of transcatheter arterial chemoembolization(TACE) and radiofrequency ablation(RFA) is superior to TACE and RFA alone in treatment of patients with hepatocellular carcinoma(HCC)greater than 3 cm and to analyze the factors affecting the outcomes.\n\nThe patients with HCC of 3 or fewer lesions, each 3cm greater in diameter entered this randomized controlled trial. The primary end point was survival, and the secondary end points were tumor response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEligibility criteria were:\n\n1. Not indicated for resection,\n2. Liver function of Child-Pugh class A or B,\n3. 3 or fewer lesion, each 3 cm greater and 7.5 cm less in greatest diameter,\n4. No portal vein involvement or extrahepatic metastasis,\n5. Lesions located at least 5mm away from the hepatic hilum or gall bladder and the common bile duct,\n6. Platelet count≥6.0×103/mm3 and the prothrombin activity≥60%, and\n7. No previous HCC treatment.\n\nExclusion Criteria:\n\nExclusion criteria were:\n\n1. Encephalopathy,\n2. Refractory ascites,\n3. Active gastrointestinal bleeding,\n4. Renal failure.'}, 'identificationModule': {'nctId': 'NCT00479050', 'acronym': 'TACE-RFA', 'briefTitle': 'Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Phase 1 Study of Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm', 'orgStudyIdInfo': {'id': '2001HCC'}, 'secondaryIdInfos': [{'id': '03BS035'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'chemoembolization ,Radiofrequency ablation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Wang Qi Liang, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept. of Radiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}}}}