Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-26 @ 11:06 PM
Study NCT ID:
NCT00720668
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
2008-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2010-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-06', 'studyFirstSubmitDate': '2008-07-21', 'studyFirstSubmitQcDate': '2008-07-21', 'lastUpdatePostDateStruct': {'date': '2009-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Rate of Exacerbation of chronic hepatitis B after RFA', 'timeFrame': 'one week, one month, one year'}], 'secondaryOutcomes': [{'measure': 'survival', 'timeFrame': '1, 3, 5-year'}, {'measure': 'mortality', 'timeFrame': 'one month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hepatitis B', 'hepatocellular carcinoma', 'radiofrequency ablation', 'reactivation'], 'conditions': ['Hepatitis B', 'Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '16250051', 'type': 'RESULT', 'citation': 'Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available.'}, {'pmid': '11923602', 'type': 'RESULT', 'citation': "Poon RT, Fan ST, Tsang FH, Wong J. Locoregional therapies for hepatocellular carcinoma: a critical review from the surgeon's perspective. Ann Surg. 2002 Apr;235(4):466-86. doi: 10.1097/00000658-200204000-00004."}, {'pmid': '16495695', 'type': 'RESULT', 'citation': 'Chen MS, Li JQ, Zheng Y, Guo RP, Liang HH, Zhang YQ, Lin XJ, Lau WY. A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. Ann Surg. 2006 Mar;243(3):321-8. doi: 10.1097/01.sla.0000201480.65519.b8.'}]}, 'descriptionModule': {'briefSummary': "This study aim to find out the risk of exacerbation of chronic hepatitis B after percutaneous radiofrequency ablation (RFA) or hepatectomy for HCC, and it's effect to treatment outcome.", 'detailedDescription': "It has been reported that HBV replication can be reacted after chemotherapy or immunotherapy, which will lead to exacerbation of chronic hepatitis B (ECHB). It is still unknown that if percutaneous radiofrequency ablation or liver resection for hepatocellular carcinoma (HCC) will react the replication of HBV or not. This study aim to find out the risk of exacerbation of chronic hepatitis B after percutaneous radiofrequency ablation (RFA) or hepatectomy for HCC, and it's effect to treatment outcome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with hepatocellular carcinoma (HCC) after percutaneous radiofrequency ablation.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 - 75 years\n* HBV carrier with HCC\n* After percutaneous radiofrequency ablation;\n* No history of encephalopathy, ascites refractory to diuretics or variceal bleeding\n* No HCV or HIV co-infection\n* No previous treatment of HCC\n* No previous treatment of HBV except Lamivudine\n\nExclusion Criteria:\n\n* Patient compliance is poor\n* Active clinically serious infections ( \\> grade 2 National Cancer Institute \\[NCI\\]-Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 3.0)\n* Known history of human immunodeficiency virus (HIV) infection\n* Known Central Nervous System tumors including metastatic brain disease\n* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry\n* Distantly extrahepatic metastasis\n* History of organ allograft\n* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results\n* Excluded therapies and medications, previous and concomitant\n* Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior randomization\n* Prior use of systemic investigational agents for HCC\n* Autologous bone marrow transplant or stem cell rescue within four months of start of study drug"}, 'identificationModule': {'nctId': 'NCT00720668', 'acronym': 'HBV-HCC', 'briefTitle': 'The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'RFA006'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'patient with hepatocellular carcinoma after radiofrequency ablation', 'interventionNames': ['Procedure: radiofrequency ablation']}], 'interventions': [{'name': 'radiofrequency ablation', 'type': 'PROCEDURE', 'otherNames': ['RFA'], 'description': 'radiofrequency ablation for HCC', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min-Shan Chen, MD', 'role': 'CONTACT', 'email': 'Chminsh@mail.sysu.edu.cn', 'phone': '86-20-87343117', 'phoneExt': '86-20-87343117'}, {'name': 'Min-Shan Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yao-Jun Zhang, Doctor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cancer Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'min-shan chen, MD', 'role': 'CONTACT', 'email': 'Chminsh@mail.sysu.edu.cn', 'phone': '86-20-87343117', 'phoneExt': '86-20-87343117'}], 'overallOfficials': [{'name': 'min-shan chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'minshan chen', 'oldOrganization': 'cancer canter, Sun Yat-sen University'}}}}