Overview

Efficacy of Antiviral Therapy After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma

Status:
Unknown status
Trial end date:
2010-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Treatments:
Antiviral Agents
Entecavir
Lamivudine
Criteria
Inclusion Criteria:

1. patients who did not receive antiviral therapy prior to the resection of
hepatocellular carcinoma

2. 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.

3. hepatitis B surface antigen should be positive before surgery HBV-DNA level between
100000 copies/ml and 10000000copies/ml anti-HCV negative

Exclusion Criteria:

1. previous history of antiviral therapy

2. a baseline serum alanine aminotransferase level 2.5 times the ULN or higher

3. positive for anti-HCV or anti-HIV

4. Child-Pugh classification B or C after surgery

5. 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

6. signs showing recurrence or metastasis oen month after surgery

7. underlying cardiac or renal diseases