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

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Capital Medical University

Status and phase

Completed
Phase 2

Conditions

Liver Transplantation
Hepatocellular Carcinoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00300521
LT2000-09

Details and patient eligibility

About

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.

Full 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.

Sex

All

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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