Efficacy and Significance of Antiviral Therapy for Unresectable Hepatitis B Virus-related Primary Liver Cancer

Study Overview
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Brief Summary
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This study is working to research the efficacy and significant of the anti-virus therapy in the unresectable Hepatitis B virus (HBV) related primary liver cancer(PLC) so as to establish treatment standards of anti-virus therapy in PLC.

Detailed Description
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primary liver cancer(PLC)is one of the world's most common malignancies, especially in East-Asian countries.Hepatitis B virus (HBV) infection is associated with 70-90% of PLC cases in China. PLC can develop during any stage of the natural course of chronic HBV infection and anti-virus therapy should be considered during the management of PLC. However, there is no definite guide on when or how to practice the anti-virus therapy, especially in unresectable or inoperable PLC. Because of these facts, research on the significant of the anti-virus therapy in the HBV-related PLC is urgently needed. 200 patients will be randomly assigned to anti-virus therapy group and control gruop.The time to progression(TTP) and overall survival within two years will be used to evaluate the effect of anti-virus therapy on PLC. The aim of this study is to research the efficacy and significant of the anti-virus therapy in the unresectable HBV-related PLC so as to establish treatment standards of anti-virus therapy in PLC.

Official Title
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A Randomized, Controlled Study to Evaluate the Efficacy and Significant of the Anti-virus Therapy for the Unresectable Hepatitis B Virus-related Primary Liver Cancer

Conditions
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Primary Liver Cancer

Intervention / Treatment
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* Drug: Entecavir
* Drug: conventional therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Identify patients with PLC in accordance with the clinical diagnostic criteria of PLC.Patients with PLC shall be diagnosed with or without pathology. It is not appropriate to perform liver resection operation. serum positive HBsAg≥6 months. Criteria of liver function: Child A or B level, serum total bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 10 times the upper limit of normal value. hemoglobin≥8.5g/dl, PT-INR≤2.3 or PT>6 seconds of normal value. No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Patients who can understand this trial, male or female, aged 18-70 voluntarily participate in clinical trials and have signed information consent. Exclusion Criteria: Patients with apparent cardiac, pulmonary, cerebric and renal dysfunction, which may affect the treatment of liver cancer. Patients with other diseases which may affect the treatment mentioned here. Patients with medical history of other malignant tumors. Subjects participating in other clinical trials. Women in pregnancy and breast-feeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: anti-virus therapy<br>100 HCC patients will be allocated to receive anti-virus therapy. | Drug: Entecavir<br>* Entecavir 0.5mg per day<br>* Other names: anti-virus group;|
| Active Comparator: conventional therapy<br>100 patients will undergo conventional therapy | Drug: conventional therapy<br>* conventional therapy including protecting the liver function, anti-tumor and so on<br>* Other names: control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time-to-progression(TTP) |  | 1,2 and 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | 1,2 and 3 years | 
| The overall response rate |  | 1,2 and 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary liver cancer, hepatitis B virus, anti-virus therapy