Efficacy and Significance of Antiviral Therapy for Unresectable Hepatitis B Virus-related Primary Liver Cancer
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|ClinicalTrials.gov Identifier: NCT00824707|
Recruitment Status : Completed
First Posted : January 19, 2009
Last Update Posted : April 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Primary Liver Cancer||Drug: Entecavir Drug: conventional therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||December 2010|
Experimental: anti-virus therapy
100 HCC patients will be allocated to receive anti-virus therapy.
Entecavir 0.5mg per day
Other Name: anti-virus group
Active Comparator: conventional therapy
100 patients will undergo conventional therapy
Drug: conventional therapy
conventional therapy including protecting the liver function, anti-tumor and so on
Other Name: control group
- time-to-progression(TTP) [ Time Frame: 1,2 and 3 years ]
- Overall survival (OS) [ Time Frame: 1,2 and 3 years ]
- The overall response rate [ Time Frame: 1,2 and 3 years ]
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): NCT00824707
|Eastern Hepatobiliary Surgery Hospital|
|Shanghai, Shanghai, China, 200438|
|Study Chair:||Shen Feng, M.D||Eastern Hepatobiliary Surgery Hospital|