Hepatocellular Carcinoma, Liver Transplantation
Conditions
Keywords
hepatocellular carcinoma, liver transplantation, adenovirus-thymidine kinase enzyme, gene therapy, immunosuppression
Brief summary
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
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.
Interventions
GENETICADV-TK (adenovirus-thymidine kinase enzyme) gene therapy
Sponsors
Tongji University
The No.180 Hospital of People's Liberation Army
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival rate at three year | — |
| overall recurrence-free survival rate at one year | — |
| overall survival rate at one year | — |
| overall survival rate at two year | — |
| overall recurrence-free survival rate at two year | — |
| overall recurrence-free survival rate at three year | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 vascular invasion on survival rate and recurrence-free survival rate | — |
| hazard rate of Child-Pugh classification on survival rate and recurrence-free survival rate | — |
| AFP level before and after liver transplantation | — |
Countries
China
Outcome results
None listed