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

This study has been completed.
Sponsor:
Collaborators:
Tongji University
The No.180 Hospital of People's Liberation Army
Information provided by:
Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT00300521
First received: March 8, 2006
Last updated: NA
Last verified: September 2000
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Liver Transplantation
 Genetic: ADV-TK (adenovirus-thymidine kinase enzyme) gene therapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Liver Transplantation With ADV-TK Gene Therapy Improves Survival in Patients With Advanced Hepatocellular Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beijing Chao Yang Hospital:

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

Estimated Enrollment: 40
Study Start Date: September 2000
Estimated Study Completion Date: November 2005
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00300521

Locations
China, Beijing
Beijing Chao Yang Hospital
Beijing, Beijing, China, 100020
Sponsors and Collaborators
Beijing Chao Yang Hospital
Tongji University
The No.180 Hospital of People's Liberation Army
Investigators
Study Chair: Ding Ma, M.D. Cancer Biology Research Center, Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology, Wuhan, Hubei 430030, P.R.China
Study Director: Ning Li, B.D Beijing Chao Yang Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00300521     History of Changes
Other Study ID Numbers: LT2000-09
Study First Received: March 8, 2006
Last Updated: March 8, 2006
Health Authority: China: Ministry of Health

Keywords provided by Beijing Chao Yang Hospital:
hepatocellular carcinoma
liver transplantation
adenovirus-thymidine kinase enzyme
gene therapy
immunosuppression

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on June 18, 2013