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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00768157

Enrollment

200

Registered

2008-10-07

Start date

2007-04-30

Completion date

2010-08-31

Last updated

2009-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B Virus, Hepatocellular Carcinoma, Recurrence

Keywords

hepatocellular carcinoma, hepatitis B virus, surgery, anti-virus, recurrence

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 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.

Interventions

DRUGantiviral treatment (lamivudine or entecavir)

antiviral treatment (lamivudine 100mg per day or entecavir 0.5mg per day)

PROCEDUREradical resection of HBV-related HCC

Procedure/Surgery - radical resection of HBV-related HCC

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall survivals	2,3,5years

Secondary

Measure	Time frame
Recurrence rate	2,3,5years

Countries

China

Contacts

Primary ContactXiang-Ming LAO, Ph.D

laoxming@mail.sysu.edu.cn8620-87343115

Backup ContactXiao-Jun LIN, Ph.D

sumslxm@sohu.com8620-87343017

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026