Preliminary Results for the Double-dose Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma

July 28, 2014 updated by: Ding Ma, Huazhong University of Science and Technology
HCC patients with tumors >5 cm in diameter, regardless of involvement in the intrahepatic and extrahepatic portal branches participated in the study. Patients were randomized allocated in liver transplantation (LT) only group and LT plus ADV-TK therapy group. All patients received orthotopic liver transplantation; in the LT plus ADV-TK group, ADV-TK therapy was delivered to patients twice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18～70 years of age (Male and Female).
  • Clinical diagnosis of advanced hepatocellular carcinoma who could accept liver transplantation
  • Patients who had unresectable HCC >5 cm and no metastasis in lungs and bones were eligible to participate in this study. Tumor involvement in the intrahepatic and extrahepatic portal branches was not considered to be an exclusion criterion.
  • No prior chemotherapy, radiation therapy, targeted therapy or other kind of biological treatment within 4 weeks.
  • Provide written informed consent

Exclusion Criteria:

  • Metastasis in lungs and bones
  • Invasion in main vescular.
  • Contraindications of liver transplantation
  • Contraindications of operation of other organ system
  • Hypersensitivity to adenovirus, GCV or similar drugs
  • Accept clinical trials of other drugs
  • Immunological deficit
  • Active pregnancy
  • Unable or unwilling to sign informed consents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LT+ADV-TK
Liver transplantation and double-dose ADV-TK/ganciclovir administration The first ADV-TK dose was administered before closing the peritoneal layer; the second ADV-TK dose was administered 2 months after LT; ganciclovir was slowly administered 36 hours after LT and twice daily for 14 days.
Drug: ganciclovir
Procedure: LT
Orthotopic LT
Other Names:
  • liver transplantation
Drug: ADV-TK
Other Names:
  • adenovirus-thymidine kinase
Active Comparator: LT
Orthotopic liver transplantation
Procedure: LT
Orthotopic LT
Other Names:
  • liver transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival rate
Time Frame: up to 3-year
up to 3-year
Recurrence-free survival rate
Time Frame: up to 3-year
up to 3-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Collaborators

Beijing YouAn Hospital

Investigators

  • Principal Investigator: Ding Ma, M.D., Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

July 26, 2014

First Submitted That Met QC Criteria

July 28, 2014

First Posted (Estimate)

July 29, 2014

Study Record Updates

Last Update Posted (Estimate)

July 29, 2014

Last Update Submitted That Met QC Criteria

July 28, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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