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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
time-to-progression(TTP)
1,2 and 3 years
No
Shen Feng, M.D
Study Chair
Eastern Hepatobiliary Surgery Hospital
China: Ministry of Health
EHBH-RCT-2008-005
NCT00824707
December 2008
December 2010
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