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Sponsored by: |
Sun Yat-sen University |
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Information provided by: | Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT00555334 |
The purpose of the investigators study is to prospectively evaluate whether lamivudine antiviral therapy will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC).
Condition | Intervention | Phase |
---|---|---|
Hepatocellular Carcinoma Liver Cancer |
Procedure: RFA Drug: lamivudine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Lamivudine as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma |
Estimated Enrollment: | 200 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
lamivudine therapy (100mg qd) after RFA
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Drug: lamivudine
lamivudine (100mg qd) after RFA
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2: Active Comparator
RFA only
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Procedure: RFA
radiofrequency ablation
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
History of cardiac disease:
Excluded therapies and medications, previous and concomitant:
Contact: Min-Shan Chen, Docter | 86-20-87343117 ext 86-20-87343117 | Chminsh@mail.sysu.edu.cn |
China, Guangdong | |
Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University | Recruiting |
Guangzhou, Guangdong, China, 510060 | |
Contact: min-shan chen, doctor 86-20-87343117 ext 86-20-87343117 Chminsh@mail.sysu.edu.cn |
Principal Investigator: | min-shan chen, doctor | Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University |
Responsible Party: | Cancer Canter, Sun Yat-sen University ( CancerCcanter, Sun Yat-sen University ) |
Study ID Numbers: | RFA-002 |
Study First Received: | November 7, 2007 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00555334 |
Health Authority: | China: Ministry of Health |
hepatocellular carcinoma liver cancer radiofrequency ablation lamivudine |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms |
Lamivudine Gastrointestinal Neoplasms Adenocarcinoma Hepatocellular carcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Anti-Infective Agents Neoplasms by Histologic Type Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Antiviral Agents Pharmacologic Actions |
Reverse Transcriptase Inhibitors Neoplasms Neoplasms by Site Anti-Retroviral Agents Therapeutic Uses Nucleic Acid Synthesis Inhibitors |