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Completed

NCT Number: NCT00300521

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Liver Transplantation Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, 100020, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADV-TK (adenovirus-thymidine kinase enzyme) gene therapy

Genetic

Primary outcomes

  1. overall survival rate at one year

  2. overall survival rate at two year

  3. overall survival rate at three year

  4. overall recurrence-free survival rate at one year

  5. overall recurrence-free survival rate at two year

  6. overall recurrence-free survival rate at three year

Secondary outcomes

  1. AFP level before and after liver transplantation

  2. hazard rate of age on survival rate and recurrence-free survival rate

  3. hazard rate of TNM stage on survival rate and recurrence-free survival rate

  4. hazard rate of Child-Pugh classification on survival rate and recurrence-free survival rate

  5. hazard rate of vascular invasion on survival rate and recurrence-free survival rate

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Collaborators

  • The No.180 Hospital of People's Liberation Army
  • Tongji University

Registry information

Important dates

Study start
2000
Study completion
2005
First posted
Mar 9, 2006
Registry last updated
Mar 9, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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