Multicenter RCT of ADV-TK Gene Therapy Improving the Outcome of Liver Transplantation for Advanced HCC

February 1, 2019 updated by: Ding Ma, Huazhong University of Science and Technology

Multicenter Randomized Controlled Trial of Adenovirus-mediated Adjuvant Gene Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma

Compare the effect of liver transplantation (LT) plus ADV-TK gene therapy versus LT only in advanced primary hepatocellular carcinoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • 301 Military Hospital
      • Beijing, China
        • Recruiting
        • General Hospital of Chinese People's Armed Police
        • Contact:
          • Yunjin Zang
      • Changsha, China
        • Recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:
          • Qifa Ye
      • Chengdu, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Lvnan Yan
      • Guangzhou, China
        • Recruiting
        • the Third Affiliated Hospital,Sun Yat-Sen University
        • Contact:
          • Guihua Chen
      • Hangzhou, China
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University
        • Contact:
          • Shusen Zheng
      • Shanghai, China
        • Recruiting
        • Zhongshan Hospital of Fudan University
        • Contact:
          • Jia Fan
      • Shenyang, China
        • Recruiting
        • The first affiliated hospital of China medical university
        • Contact:
          • Yongfeng Liu
      • Tianjin, China
        • Recruiting
        • The First Center Hospital of Tianjin
        • Contact:
          • Zhongyang Shen
      • Urumqi, China
        • Recruiting
        • The First Hospital of Xinjiang Medical University
        • Contact:
          • Hao Wen
    • Beijing
      • Beijing, Beijing, China, 10001
        • Recruiting
        • Beijing YouAn Hospital
        • Contact:
          • Ning Li, Dr

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 - 65 years of age (Male and Female).
  • Clinical diagnosis of advanced primary hepatocellular carcinoma who could accept liver transplantation.
  • Patients who had unresectable HCC with single tumor diameter > 5 cm and ≤ 10cm; or numbers of multiple tumors >3 and ≤ 5, and the total length of foci diameter ≤ 15 cm.
  • Serum AFP ≤ 10000 ng/ml before liver transplantation.
  • Child-pugh A-B.
  • No metastasis in extrahepatic main vescular and extrahepatic lymph node detected during the operation and no metastasis of other organs.
  • Provide written informed consent before screening.

Exclusion Criteria:

  • Metastasis in extrahepatic organs.
  • HCC with Invasion in extrahepatic main vescular and extrahepatic organs.
  • Contraindications of operation of other organ system.
  • Hypersensitivity to adenovirus, GCV or similar drugs.
  • Serious obstacle of the mechanism of coagulation, hemorrhagic tendency, and abnormal coagulation (≥50%).
  • Plan to accept clinical trials of other antitumor drugs.
  • Immunological deficit.
  • HBsAg(+) and HBcAb(+) donor.
  • Unsuitable participate assessed by investigator.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LT-only
patients received orthotopic LT and subsequent immunosuppression therapy
Procedure: LT
Orthotopic LT and subsequent immunosuppression therapy
Experimental: LT+ADV-TK
ADV-TK therapy was administered in addition to orthotopic LT and subsequent immunosuppression therapy
Procedure: LT
Orthotopic LT and subsequent immunosuppression therapy
Drug: ADV-Tk
The first ADV-TK dose was administered during the operation; 1.0×10(12) viral particles of ADV-TK in 100 mL of 0.9% saline were injected into peritoneum tissues around the liver. The second and third ADV-TK dose was administered 60 days and 90 days after LT; 1.0×10(12) viral particles of ADV-TK in 100 mL of 0.9% saline were injected into the celiac artery (60 mL) and the superior mesenteric artery (40 mL) via femoral-artery puncture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival, PFS
Time Frame: 2-year
PFS was measured from the day of liver transplantation to objective recurrence (MRI or CT) or HCC-related death, whichever occurred first.
2-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival, OS
Time Frame: 1-year
OS was measured from the day of liver transplantation to death.
1-year
Overall survival, OS
Time Frame: 2-year
OS was measured from the day of liver transplantation to death.
2-year
Time of the tumor progression,TTP
Time Frame: 2-year
TTP was the median period from the day of liver transplantation to objective recurrence (MRI or CT).
2-year
Median overall survival time
Time Frame: 2-year
2-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

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

March 1, 2013

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

October 8, 2017

First Submitted That Met QC Criteria

October 13, 2017

First Posted (Actual)

October 18, 2017

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on LT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe