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Efficacy of Antiviral Therapy With Lamivudine or Entecavir After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma


Phase 4
18 Years
75 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma, Hepatitis B Virus, Recurrence

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Trial Information

Efficacy of Antiviral Therapy With Lamivudine or Entecavir After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma


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 of hepatocellular carcinoma.To investigated whether anti-viral therapy
could improve the efficacy of radical resection of hepatitis B virus (HBV)-related
hepatocellular carcinoma(HCC),we planed to conduct this clinical trial.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survivals

Outcome Time Frame:

2,3,5years

Safety Issue:

Yes

Principal Investigator

Jin-Qing LI, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Center of Sun Yat-sen University

Authority:

China: Ministry of Health

Study ID:

SYSUCC-HCC004

NCT ID:

NCT00768157

Start Date:

April 2007

Completion Date:

August 2010

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatitis B Virus
  • Recurrence
  • hepatocellular carcinoma
  • hepatitis B virus
  • surgery
  • anti-virus
  • recurrence
  • Carcinoma
  • Hepatitis
  • Hepatitis A
  • Hepatitis B
  • Recurrence
  • Virus Diseases
  • Carcinoma, Hepatocellular

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