Clinical trial NCT00300521: Liver Transplantation With ADV-TK Gene Therapy Improves Survival in Patients With Advanced Hepatocellular Carcinoma
Official title: Liver Transplantation With ADV-TK Gene Therapy Improves Survival in Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Liver Transplantation
Keywords: hepatocellular carcinoma
liver transplantation
adenovirus-thymidine kinase enzyme
gene therapy
immunosuppression
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
Collaborators: name: Tongji University
name: The No.180 Hospital of People's Liberation Army
First posted: 2006-03-09
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: overall survival rate at one year
measure: overall survival rate at two year
measure: overall survival rate at three year
measure: overall recurrence-free survival rate at one year
measure: overall recurrence-free survival rate at two year
measure: overall recurrence-free survival rate at three year
Secondary outcomes:
measure: AFP level before and after liver transplantation
measure: hazard rate of age on survival rate and recurrence-free survival rate
measure: hazard rate of TNM stage on survival rate and recurrence-free survival rate
measure: hazard rate of Child-Pugh classification on survival rate and recurrence-free survival rate
measure: hazard rate of vascular invasion on survival rate and recurrence-free survival rate
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao Yang Hospital
state: Beijing
Study officials:
affiliation: Cancer Biology Research Center, Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology, Wuhan, Hubei 430030, P.R.China
name: Ding Ma, M.D.
role: STUDY_CHAIR
affiliation: Beijing Chao Yang Hospital
name: Ning Li, B.D
role: STUDY_DIRECTOR
References: