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

Not Applicable

Completed

• Conditions: Primary Liver Cancer
• Interventions: Drug: Entecavir; Drug: conventional therapy

• Registration Number: NCT00824707
• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-16
• Study First Submitted QC: 2009-01-16
• Study First Posted: 2009-01-19
• Primary Completion: 2010-11
• Study Completion: 2010-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. 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.
2. serum positive HBsAg≥6 months.
3. 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.
4. hemoglobin≥8.5g/dl, PT-INR≤2.3 or PT>6 seconds of normal value.
5. No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
6. Patients who can understand this trial, male or female, aged 18-70 voluntarily participate in clinical trials and have signed information consent.

Exclusion Criteria

1. Patients with apparent cardiac, pulmonary, cerebric and renal dysfunction, which may affect the treatment of liver cancer.
2. Patients with other diseases which may affect the treatment mentioned here.
3. Patients with medical history of other malignant tumors.
4. Subjects participating in other clinical trials.
5. Women in pregnancy and breast-feeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anti-virus therapy	Entecavir	100 HCC patients will be allocated to receive anti-virus therapy.
conventional therapy	conventional therapy	100 patients will undergo conventional therapy

Primary Outcome Measures

Name	Time	Method
time-to-progression(TTP)	1,2 and 3 years

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	1,2 and 3 years
The overall response rate	1,2 and 3 years

Trial Locations

Locations (1)

Eastern Hepatobiliary Surgery Hospital; 🇨🇳 Shanghai, Shanghai, China