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

NCT ID: NCT00300521

Last Updated: 2006-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2005-11-30

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma Liver Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji University

OTHER

Sponsor Role collaborator

The No.180 Hospital of People's Liberation Army

UNKNOWN

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Ding Ma, M.D.

Role: STUDY_CHAIR

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

Ning Li, B.D

Role: STUDY_DIRECTOR

Beijing Chao Yang Hospital

Locations

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Beijing Chao Yang Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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LT2000-09

Identifier Type: -

Identifier Source: org_study_id