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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatocellular Carcinoma, Liver Transplantation

Intervention / Treatment
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* Genetic: ADV-TK (adenovirus-thymidine kinase enzyme) gene therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: ADV-TK (adenovirus-thymidine kinase enzyme) gene therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, liver transplantation, adenovirus-thymidine kinase enzyme, gene therapy, immunosuppression