Efficacy and Significance of Antiviral Therapy for Unresectable Hepatitis B Virus-Related Primary Liver Cancer - Full Text View

Sponsored by:	Eastern Hepatobiliary Surgery Hospital
Information provided by:	Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:	NCT00824707

Purpose

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.

Condition	Intervention
Primary Liver Cancer	Drug: Entecavir Drug: conventional therapy

MedlinePlus related topics: Cancer Hepatitis Hepatitis B Liver Cancer Surgery

Drug Information available for: Entecavir Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:

time-to-progression(TTP) [ Time Frame: 1,2 and 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival (OS) [ Time Frame: 1,2 and 3 years ] [ Designated as safety issue: No ]
The overall response rate [ Time Frame: 1,2 and 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
anti-virus therapy: Experimental 100 HCC patients will be allocated to receive anti-virus therapy.	Drug: Entecavir Entecavir 0.5mg per day
conventional therapy: Active Comparator 100 patients will undergo conventional therapy	Drug: conventional therapy conventional therapy including protecting the liver function, anti-tumor and so on

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824707

Locations

China
Eastern Hepatobiliary Surgery Hospital
Shanghai, China, 200438

Sponsors and Collaborators

Eastern Hepatobiliary Surgery Hospital

Investigators

Study Chair:

Shen Feng, M.D

Eastern Hepatobiliary Surgery Hospital

More Information

No publications provided

Responsible Party:	Eastern Hepatobiliary Surgery Hospital ( Heping Hu )
Study ID Numbers:	EHBH-RCT-2008-005
Study First Received:	January 16, 2009
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00824707 History of Changes
Health Authority:	China: Ministry of Health

Keywords provided by Eastern Hepatobiliary Surgery Hospital:

primary liver cancer
hepatitis B virus
anti-virus therapy

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Neoplasms
Liver Diseases
Entecavir
Digestive System Neoplasms

Digestive System Diseases
Hepatitis B
Gastrointestinal Neoplasms
Hepatitis, Viral, Human
DNA Virus Infections
Antiviral Agents

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Digestive System Neoplasms
Hepatitis, Viral, Human
Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions
Hepatitis
Liver Neoplasms

Virus Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Entecavir
Therapeutic Uses
Hepatitis B
DNA Virus Infections

ClinicalTrials.gov processed this record on May 07, 2009