Status:
UNKNOWN
Efficacy of Antiviral Therapy After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hepatocellular Carcinoma
Hepatitis B Virus
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Most hepatocellular carcinomas are associated with hepatitis B virus, it is hypothesized that anti-viral treatment may be helpful in treating HBV-related hepatocellular carcinoma.
Detailed Description
As we know, recurrence and metastasis could happen in hepatocellular carcinoma even after radical resection.One reason is that virus hepatitis B could be one factor contributing to the carcinogenesis ...
Eligibility Criteria
Inclusion
- patients who did not receive antiviral therapy prior to the resection of hepatocellular carcinoma
- patients who underwent radical resection of HCC, and 1 month after surgery,dynamic computed tomography showed on lesion in the liver and no signs of extrahepatic metastasis.
- hepatitis B surface antigen should be positive before surgery HBV-DNA level between 100000 copies/ml and 10000000copies/ml anti-HCV negative
Exclusion
- previous history of antiviral therapy
- a baseline serum alanine aminotransferase level 2.5 times the ULN or higher
- positive for anti-HCV or anti-HIV
- Child-Pugh classification B or C after surgery
- preexisting evidence of hepatic decompensation, including encephalopathy,ascites,a bilirubin level more than 2 times the ULN, or a prolonged prothrombin time of more than 3 seconds
- signs showing recurrence or metastasis oen month after surgery
- underlying cardiac or renal diseases
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00768157
Start Date
April 1 2007
End Date
August 1 2010
Last Update
February 9 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Xiang-Ming Lao
Guangzhou, Guangdong, China, 510060