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

Primary Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00824707
• Other study ID #: EHBH-RCT-2008-005
• Status: Completed
• Phase: N/A
• First received: January 16, 2009
• Last updated: March 30, 2016
• Start date: December 2008
• Est. completion date: December 2010

Study information

• Verified date: March 2016
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis B
• Liver Neoplasms
• Primary Liver Cancer

Intervention

Drug:
• Entecavir
Entecavir 0.5mg per day
• conventional therapy
conventional therapy including protecting the liver function, anti-tumor and so on

Locations

Country	Name	City	State
China	Eastern Hepatobiliary Surgery Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time-to-progression(TTP)		1,2 and 3 years	No
Secondary	Overall survival (OS)		1,2 and 3 years	No
Secondary	The overall response rate		1,2 and 3 years	No