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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatocellular Carcinoma, Hepatitis B Virus, Recurrence

Intervention / Treatment
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* Drug: antiviral treatment (lamivudine or entecavir)
* Procedure: radical resection of HBV-related HCC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: antiviral group<br>Drug: antiviral treatment(lamivudine or entecavir) after the Procedure/Surgery (radical resection of HBV-related HCC) | Drug: antiviral treatment (lamivudine or entecavir)<br>* antiviral treatment (lamivudine 100mg per day or entecavir 0.5mg per day)<br>Procedure: radical resection of HBV-related HCC<br>* Procedure/Surgery - radical resection of HBV-related HCC<br>|
| Active Comparator: control group<br>Procedure/Surgery (radical resection of HBV-related HCC) without Drug of antiviral treatment - close observation without antiviral treatment | Procedure: radical resection of HBV-related HCC<br>* Procedure/Surgery - radical resection of HBV-related HCC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survivals |  | 2,3,5years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate |  | 2,3,5years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, hepatitis B virus, surgery, anti-virus, recurrence