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

NCT00300521 | Completed Phase 2

• 1 other identifier: LT2000-09
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Liver Transplantation

Keywords

hepatocellular carcinoma; liver transplantation; adenovirus-thymidine kinase enzyme; gene therapy; immunosuppression

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• 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

Interventions

ADV-TK (adenovirus-thymidine kinase enzyme) gene therapy GENETIC

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of advanced hepatocellular carcinoma with no metastasis in lungs and bones
• Accept Liver Transplantation

You may not qualify if:

• Small hepatocellular carcinoma
• Advanced hepatocellular with metastasis in lungs and bones

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead
• Tongji University: collaborator
• The No.180 Hospital of People's Liberation Army: collaborator

Study Sites (1)

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, 100020, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Genetic Therapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Genetic Engineering; Genetic Techniques; Investigative Techniques

Study Officials

• Ding Ma, M.D.

  Cancer Biology Research Center, Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology, Wuhan, Hubei 430030, P.R.China

  STUDY CHAIR

• Ning Li, B.D

  Beijing Chao Yang Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 8, 2006
• First Posted: March 9, 2006
• Study Start: September 1, 2000
• Study Completion: November 1, 2005
• Last Updated: March 9, 2006

Record last verified: 2000-09

Locations

CN (1)