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Liver Transplantation With ADV-TK Gene Therapy Improves Survival in Patients With Advanced Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma, Liver Transplantation

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ADV-TK (adenovirus-thymidine kinase enzyme) gene therapy
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, liver transplantation, adenovirus-thymidine kinase enzyme, gene therapy, immunosuppression

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical diagnosis of advanced hepatocellular carcinoma with no metastasis in lungs and bones Accept Liver Transplantation Exclusion Criteria: Small hepatocellular carcinoma Advanced hepatocellular with metastasis in lungs and bones

Sites / Locations

  • Beijing Chao Yang Hospital

Outcomes

Primary Outcome Measures

overall survival rate at one year
overall survival rate at two year
overall survival rate at three year
overall recurrence-free survival rate at one year
overall recurrence-free survival rate at two year
overall recurrence-free survival rate at three year

Secondary Outcome Measures

AFP level before and after liver transplantation
hazard rate of age on survival rate and recurrence-free survival rate
hazard rate of TNM stage on survival rate and recurrence-free survival rate
hazard rate of Child-Pugh classification on survival rate and recurrence-free survival rate
hazard rate of vascular invasion on survival rate and recurrence-free survival rate

Full Information

First Posted
March 8, 2006
Last Updated
March 8, 2006
Sponsor
Beijing Chao Yang Hospital
Collaborators
Tongji University, The No.180 Hospital of People's Liberation Army
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1. Study Identification

Unique Protocol Identification Number
NCT00300521
Brief Title
Liver Transplantation With ADV-TK Gene Therapy Improves Survival in Patients With Advanced Hepatocellular Carcinoma
Official Title
Liver Transplantation With ADV-TK Gene Therapy Improves Survival in Patients With Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2000
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Beijing Chao Yang Hospital
Collaborators
Tongji University, The No.180 Hospital of People's Liberation Army

4. Oversight

5. Study Description

Brief Summary
Previous rather poor results in liver transplantation (LT) of patients with advanced hepatocellular carcinoma (HCC) have made the application of LT very limited in treatment of HCC. The advantages of ADV-TK gene therapy highlight its potentiality as adjuvant treatment for HCC patients after LT. We reported here the improved outcome of LT with combined treatment of ADV-TK gene therapy in patients with intermediate or advanced HCC.
Detailed Description
The overall survival in the LT with ADV-TK gene therapy group was 54.8 % at three years, and the recurrence-free survival in the same group was 56.5 %, both being higher than those in the transplantation only group (P=0.0001 for overall survival and P=0.0000 for recurrence-free survival). In no-vascular invasion subgroup treated with LT with ADV-TK therapy, both overall survival and recurrence-free survival were 100 %, significantly higher than those with vascular invasion subgroup treated with the combined LT and ADV-TK therapy (P=0 for each group). Vascular invasion was an important factor affected survival and recurrence, hazard ratio=3.687; P=0.014 and hazard ratio=12.961; P=0.000, respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Liver Transplantation
Keywords
hepatocellular carcinoma, liver transplantation, adenovirus-thymidine kinase enzyme, gene therapy, immunosuppression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
ADV-TK (adenovirus-thymidine kinase enzyme) gene therapy
Primary Outcome Measure Information:
Title
overall survival rate at one year
Title
overall survival rate at two year
Title
overall survival rate at three year
Title
overall recurrence-free survival rate at one year
Title
overall recurrence-free survival rate at two year
Title
overall recurrence-free survival rate at three year
Secondary Outcome Measure Information:
Title
AFP level before and after liver transplantation
Title
hazard rate of age on survival rate and recurrence-free survival rate
Title
hazard rate of TNM stage on survival rate and recurrence-free survival rate
Title
hazard rate of Child-Pugh classification on survival rate and recurrence-free survival rate
Title
hazard rate of vascular invasion on survival rate and recurrence-free survival rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of advanced hepatocellular carcinoma with no metastasis in lungs and bones Accept Liver Transplantation Exclusion Criteria: Small hepatocellular carcinoma Advanced hepatocellular with metastasis in lungs and bones
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ding Ma, M.D.
Organizational Affiliation
Cancer Biology Research Center, Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology, Wuhan, Hubei 430030, P.R.China
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ning Li, B.D
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Chao Yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China

12. IPD Sharing Statement

Learn more about this trial

Liver Transplantation With ADV-TK Gene Therapy Improves Survival in Patients With Advanced Hepatocellular Carcinoma

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