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

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma; Liver Transplantation

• Registration Number: NCT00300521
• Lead Sponsor: Beijing Chao Yang Hospital

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.

Study Timeline

• Status Verified: 2000-09
• Study Start: 2000-09
• Study Completion: 2005-11
• Study First Submitted: 2006-03-08
• Study First Submitted QC: 2006-03-08
• Last Update Submitted: 2006-03-08
• Study First Posted: 2006-03-09
• Last Update Posted: 2006-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Beijing Chao Yang Hospital; 🇨🇳 Beijing, Beijing, China