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

Primary Purpose

Primary Liver Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Entecavir
conventional therapy
Sponsored by
Eastern Hepatobiliary Surgery Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Liver Cancer focused on measuring primary liver cancer, hepatitis B virus, anti-virus therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eastern Hepatobiliary Surgery Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

anti-virus therapy

conventional therapy

Arm Description

100 HCC patients will be allocated to receive anti-virus therapy.

100 patients will undergo conventional therapy

Outcomes

Primary Outcome Measures

time-to-progression(TTP)

Secondary Outcome Measures

Overall survival (OS)
The overall response rate

Full Information

First Posted
January 16, 2009
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00824707
Brief Title
Efficacy and Significance of Antiviral Therapy for Unresectable Hepatitis B Virus-related Primary Liver Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Liver Cancer
Keywords
primary liver cancer, hepatitis B virus, anti-virus therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anti-virus therapy
Arm Type
Experimental
Arm Description
100 HCC patients will be allocated to receive anti-virus therapy.
Arm Title
conventional therapy
Arm Type
Active Comparator
Arm Description
100 patients will undergo conventional therapy
Intervention Type
Drug
Intervention Name(s)
Entecavir
Other Intervention Name(s)
anti-virus group
Intervention Description
Entecavir 0.5mg per day
Intervention Type
Drug
Intervention Name(s)
conventional therapy
Other Intervention Name(s)
control group
Intervention Description
conventional therapy including protecting the liver function, anti-tumor and so on
Primary Outcome Measure Information:
Title
time-to-progression(TTP)
Time Frame
1,2 and 3 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
1,2 and 3 years
Title
The overall response rate
Time Frame
1,2 and 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen Feng, M.D
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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