Trial | NCT00300521  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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.
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.
Study Started
Sep 30
2000
Study Completion
Nov 30
2005
Last Update
Mar 09
2006
Estimate

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

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
No Results Posted