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Sponsored by: |
Sun Yat-sen University |
Information provided by: | Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT00728078 |
The purpose of our study is to prospectively evaluate whether low-dose thalidomide adjuvant therapy will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC).
Condition | Intervention | Phase |
Hepatocellular Carcinoma Liver Cancer |
Drug: thalidomide |
Phase II Phase III |
MedlinePlus related topics: | Cancer Liver Cancer |
ChemIDplus related topics: | Thalidomide |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Low-Dose Thalidomide as Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma |
Estimated Enrollment: | 200 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
low-dose thalidomide adjuvant therapy after RFA for HCC
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Drug: thalidomide
thalidomide 50mg tid for 6 months
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2: No Intervention
control group
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Our previous studies showed that radiofrequency ablation (RFA) was as effective as liver resection for small hepatocellular carcinoma (HCC), but the recurrence rates after RFA were relatively high. Adjuvant therapies maybe reduce the recurrence rate. Phase 1 and 2 studies showed that thalidomide was a safety and effective treatment for HCC, especially for small HCC with liver cirrhosis. So we proposed that low-dose thalidomide adjuvant therapy will improve the disease progress free survivals and overall survivals after RFA for HCC.
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:
Contact: min-shan chen, MD | 86-20-87343117 ext 86-20-87343117 | Chminsh@mail.sysu.edu.cn |
China, Guangdong | |||||
Cancer Center, Sun Yat-sen University | Recruiting | ||||
Guangzhou, Guangdong, China, 510060 | |||||
Contact: min-shan chen, MD 86-20-87343117 ext 86-20-87343117 Chminsh@mail.sysu.edu.cn | |||||
Contact: min-shan chen, MD 86-20-87343117 ext 86-20-87343117 Chminsh@mail.sysu.edu.cn | |||||
Principal Investigator: min-shan chen, MD | |||||
Sub-Investigator: yao-jun zhang, Doctor |
Sun Yat-sen University |
Principal Investigator: | min-shan chen, MD | Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University |
Responsible Party: | cancer canter, Sun Yat-sen University ( cancer canter, Sun Yat-sen University ) |
Study ID Numbers: | RFA005 |
First Received: | July 31, 2008 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00728078 |
Health Authority: | China: Ministry of Health |
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