Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC

Study Overview
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Brief Summary
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This study aims to compare the effect of antiviral therapy with entecavir or tenofovir for hepatitis B virus-related hepatocellular carcinoma after radical hepatectomy. Included patients will randomly divide into two groups.

Detailed Description
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Hepatocellular carcinoma (HCC) is associated with a poor prognosis, and its incidence has increased dramatically in many countries. Hepatectomy is a radical therapy for early-stage HCC. However, even after radical resection, the prognosis for HCC patients remains discouraging because of the high recurrence rate and frequent incidence of intrahepatic metastasis. Therefore, preventing HCC recurrence is very important. Hepatitis B virus (HBV) infection is the major risk factor for HCC development in China. Some retrospective studies have shown that tenofovir or entecavir treatment for HBV-related HCC patients can effectively reduce the HCC recurrence rate and increase the survival rate after hepatectomy. However, which drug has more efficacy has not been addressed.

Official Title
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Adjuvant Entecavir or Tenofovir for Hepatitis B Virus Related Hepatocellular Carcinoma After Curative Hepatic Resection

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Entecavir
* Drug: Tenofovir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Underwent hepatic resection. Diagnosis of HCC was confirmed by postoperative histopathology. Positive of HBsAg, HBeAg, or HBV DNA. Child-Pugh A or B liver function. Exclusion Criteria: Anti-HCV(+) Diagnosis of HCC was not confirmed by postoperative histopathology of surgical samples after surgery.

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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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Entecavir<br>Patients will be received entecavir (10 mg/d) after 3 days of liver resection. | Drug: Entecavir<br>* Patients will be received entecavir (10 mg/d) before liver resection.<br>* Other names: ETV;|
| Active Comparator: Tenofovir<br>Patients will be received tenofovir (1#/d) after 3 days of liver resection. | Drug: Tenofovir<br>* Patients will be received tenofovir before liver resection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate |  | 1-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adjuvant, entecavir, hepatocellular carcinoma, hepatic resection