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


Phase 2
N/A
N/A
Not Enrolling
Both
Hepatocellular Carcinoma, Liver Transplantation

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival rate at one year

Principal Investigator

Ding Ma, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

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

Authority:

China: Ministry of Health

Study ID:

LT2000-09

NCT ID:

NCT00300521

Start Date:

September 2000

Completion Date:

November 2005

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver Transplantation
  • hepatocellular carcinoma
  • liver transplantation
  • adenovirus-thymidine kinase enzyme
  • gene therapy
  • immunosuppression
  • Carcinoma
  • Carcinoma, Hepatocellular

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