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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00300521
• Other study ID #: LT2000-09
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2006
• Last updated: March 8, 2006
• Start date: September 2000
• Est. completion date: November 2005

Study information

• Verified date: September 2000
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Transplantation

Intervention

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

Locations

Country	Name	City	State
China	Beijing Chao Yang Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital	The No.180 Hospital of People's Liberation Army, Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival rate at one year
Primary	overall survival rate at two year
Primary	overall survival rate at three year
Primary	overall recurrence-free survival rate at one year
Primary	overall recurrence-free survival rate at two year
Primary	overall recurrence-free survival rate at three year
Secondary	AFP level before and after liver transplantation
Secondary	hazard rate of age on survival rate and recurrence-free survival rate
Secondary	hazard rate of TNM stage on survival rate and recurrence-free survival rate
Secondary	hazard rate of Child-Pugh classification on survival rate and recurrence-free survival rate
Secondary	hazard rate of vascular invasion on survival rate and recurrence-free survival rate