Phase Ⅲ Randomized Trial in Postoperative Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT00149565|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : December 16, 2005
- To investigate whether adjuvant IFN-α therapy can delay or reduce the 2-5 years recurrence rate in curatively resected HCC .
- To examine whether adjuvant IFN-α therapy can prolong the disease-free survival in curatively resected HCC.
- To determine the safety and tolerance of adjuvant IFN-α therapy in postoperative HCC with or without cirrhosis.
- To investigate the change of activity of HBV and HCV in postoperative HCC patients with adjuvant IFN-α therapy.
- To correlate the changes of viral status with the clinical outcome in post-operative HCC patients with adjuvant IFN-α therapy.
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: IFN-α2b||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||268 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hepatocellular Carcinoma Postoperative Adjuvant Therapy Disease Committee of Taiwan Cooperative Oncology Group|
|Study Start Date :||October 1997|
|Study Completion Date :||July 2005|
- 134 patients for each of the two treatment arms are needed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149565
|Chang Gung Memorial Hospital|
|Tao-Yuan, Taiwan, 333|
|Study Chair:||Li-Tzong Chen, Ph.D.||Hepatocellular Carcinoma Postoperative Adjuvant Therapy Disease Committee of TCOG|
|Study Chair:||Pei-Jer Chen, Ph.D.||Hepatocellular Carcinoma Postoperative Adjuvant Therapy Disease Committee of TCOG|