Entecavir for Chronic Hepatitis B in Hepatocellular Carcinoma Patients Underwent Radiofrequency Ablation Therapy

Study Overview
=================
Brief Summary
-----------------
Persistent replication of HBV (47-55%) is frequently found in patients with HCC, which in turn leads to deterioration of liver reserve. Moreover, a large proportion of HCC patients who underwent curative therapy died from progressive liver decompensation rather than recurrence of cancer. It had been proved that anti-viral therapy for hepatitis C virus (HCV)-related HCC patients could reduce the rate of tumor recurrence after surgical resection. This is a prospective study to evaluate the efficacy of ETV therapy in chronic hepatitis B patients after receiving RFA therapy for HCC.

Official Title
-----------------
Prospective Trial of Entecavir for Chronic Hepatitis B in Hepatocellular Carcinoma Patients Underwent Radiofrequency Ablation Therapy

Conditions
-----------------
Chronic Hepatitis B, Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Entecavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCC diagnosed by pathology verification or in accordance with the guidelines of American Association for the Study of Liver Diseases published in 2010 (typical vascular pattern in computed tomography scan or magnetic resonance imaging study) , Solitary tumor less than 5 cm in diameter or 2-3 tumors with the largest one no more than 3 cm in diameter, No extrahepatic metastasis, No radiological evidence of invasion into major portal vein or hepatic vein branches, Good liver reserve with Child-Pugh Class A or B, A platelet count of more than 50,000/mm3, Serum creatinine level ≤ 2 mg/dL, No previous treatment for HCC, Positive for serum hepatitis B surface antigen (HBsAg) for more than 6 months Positive serum HBV DNA using a Cobas Amplicor HBV monitor (Roche Diagnostic System, Basel, Switzerland). Exclusion Criteria: Dual or multiple infections with hepatitis C virus, hepatitis D virus, or the human immunodeficiency virus, Other forms of liver disease such as alcoholic hepatitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, Use of interferon alpha, thymosin or antiviral agents within 6 months preceding entry into the study, Women who are pregnant or nursing.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Entecavir<br> | Drug: Entecavir<br>* film coated tablets / 0.5mg / once daily / 3 years<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The survival rate and recurrence rate between patients receiving ETV therapy and those in historical control |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV reactivation, incidence of ALT normalization, reduction of serum HBV DNA level, HBsAg loss and HBsAg seroconversion to anti-HBsAb, emergence of resistance. |  | 3 years |