Clinical Trial: Efficacy and Significance of Antiviral Therapy for Unresectable Hepatitis B Virus-related Primary Liver Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Controlled Study to Evaluate the Efficacy and Significant of the Anti-virus Therapy for the Unresectable Hepatitis B Virus-related Primary Liver Cancer
Brief Summary: This study is working to research the efficacy and significant of the anti-virus therapy in the unresectable Hepatitis B virus (HBV) related primary liver cancer(PLC) so as to establish treatment standards of anti-virus therapy in PLC.
Detailed Summary:
primary liver cancer(PLC)is one of the world's most common malignancies, especially in East-Asian countries.Hepatitis B virus (HBV) infection is associated with 70-90% of PLC cases in China. PLC can develop during any stage of the natural course of chronic HBV infection and anti-virus therapy should be considered during the management of PLC. However, there is no definite guide on when or how to practice the anti-virus therapy, especially in unresectable or inoperable PLC. Because of these facts, research on the significant of the anti-virus therapy in the HBV-related PLC is urgently needed.
200 patients will be randomly assigned to anti-virus therapy group and control gruop.The time to progression(TTP) and overall survival within two years will be used to evaluate the effect of anti-virus therapy on PLC.
The aim of this study is to research the efficacy and significant of the anti-virus therapy in the unresectable HBV-related PLC so as to establish treatment standards of anti-virus therapy in PLC.
Sponsor: Eastern Hepatobiliary Surgery Hospital
Current Primary Outcome: time-to-progression(TTP) [ Time Frame: 1,2 and 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Overall survival (OS) [ Time Frame: 1,2 and 3 years ]
- The overall response rate [ Time Frame: 1,2 and 3 years ]
Original Secondary Outcome: Same as current
Information By: Eastern Hepatobiliary Surgery Hospital
Dates:
Date Received: January 16, 2009
Date Started: December 2008
Date Completion:
Last Updated: March 30, 2016
Last Verified: March 2016