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

Sun Yat-sen University

Status and phase: Unknown; Phase 4

Conditions: Hepatitis B Virus; Hepatocellular Carcinoma; Recurrence

Treatments: Drug: antiviral treatment (lamivudine or entecavir); Procedure: radical resection of HBV-related HCC

Study type: Interventional

Funder types: Other

Identifiers

NCT00768157

SYSUCC-HCC004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

antiviral group

Experimental group

Description:

Drug: antiviral treatment(lamivudine or entecavir) after the Procedure/Surgery (radical resection of HBV-related HCC)

Treatment:

Procedure: radical resection of HBV-related HCC

Drug: antiviral treatment (lamivudine or entecavir)

control group

Active Comparator group

Description:

Procedure/Surgery (radical resection of HBV-related HCC) without Drug of antiviral treatment - close observation without antiviral treatment

Treatment:

Procedure: radical resection of HBV-related HCC