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

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
ADV-Tk
LT
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Youan HospitalRecruiting
  • 301 Military HospitalRecruiting
  • General Hospital of Chinese People's Armed PoliceRecruiting
  • The Third XiangYa Hospital of Central South UniversityRecruiting
  • West China Hospital of Sichuan UniversityRecruiting
  • The Third Affiliated Hospital,Sun Yat-sen UniversityRecruiting
  • The First Affiliated Hospital, Zhejiang UniversityRecruiting
  • Zhongshan Hospital of Fudan UniversityRecruiting
  • The First Affiliated Hospital of China Medical UniversityRecruiting
  • The First Center Hospital of TianjinRecruiting
  • The First Hospital of Xinjiang Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

LT-only

LT+ADV-TK

Arm Description

patients received orthotopic LT and subsequent immunosuppression therapy

ADV-TK therapy was administered in addition to orthotopic LT and subsequent immunosuppression therapy

Outcomes

Primary Outcome Measures

Progression-free survival, PFS
PFS was measured from the day of liver transplantation to objective recurrence (MRI or CT) or HCC-related death, whichever occurred first.

Secondary Outcome Measures

Overall survival, OS
OS was measured from the day of liver transplantation to death.
Overall survival, OS
OS was measured from the day of liver transplantation to death.
Time of the tumor progression,TTP
TTP was the median period from the day of liver transplantation to objective recurrence (MRI or CT).
Median overall survival time

Full Information

First Posted
October 8, 2017
Last Updated
February 1, 2019
Sponsor
Huazhong University of Science and Technology
Collaborators
Beijing YouAn Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03313596
Brief Title
Multicenter RCT of ADV-TK Gene Therapy Improving the Outcome of Liver Transplantation for Advanced HCC
Official Title
Multicenter Randomized Controlled Trial of Adenovirus-mediated Adjuvant Gene Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
Collaborators
Beijing YouAn Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LT-only
Arm Type
Active Comparator
Arm Description
patients received orthotopic LT and subsequent immunosuppression therapy
Arm Title
LT+ADV-TK
Arm Type
Experimental
Arm Description
ADV-TK therapy was administered in addition to orthotopic LT and subsequent immunosuppression therapy
Intervention Type
Drug
Intervention Name(s)
ADV-Tk
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
LT
Intervention Description
Orthotopic LT and subsequent immunosuppression therapy
Primary Outcome Measure Information:
Title
Progression-free survival, PFS
Description
PFS was measured from the day of liver transplantation to objective recurrence (MRI or CT) or HCC-related death, whichever occurred first.
Time Frame
2-year
Secondary Outcome Measure Information:
Title
Overall survival, OS
Description
OS was measured from the day of liver transplantation to death.
Time Frame
1-year
Title
Overall survival, OS
Description
OS was measured from the day of liver transplantation to death.
Time Frame
2-year
Title
Time of the tumor progression,TTP
Description
TTP was the median period from the day of liver transplantation to objective recurrence (MRI or CT).
Time Frame
2-year
Title
Median overall survival time
Time Frame
2-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danhui Weng, Dr.
Phone
027-83663351
Email
weng.dh@gmail.com
Facility Information:
Facility Name
Beijing Youan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
10001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Li, Dr
Facility Name
301 Military Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiahong Dong
Facility Name
General Hospital of Chinese People's Armed Police
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunjin Zang
Facility Name
The Third XiangYa Hospital of Central South University
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qifa Ye
Facility Name
West China Hospital of Sichuan University
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lvnan Yan
Facility Name
The Third Affiliated Hospital,Sun Yat-sen University
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guihua Chen
Facility Name
The First Affiliated Hospital, Zhejiang University
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shusen Zheng
Facility Name
Zhongshan Hospital of Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Fan
Facility Name
The First Affiliated Hospital of China Medical University
City
Shenyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongfeng Liu
Facility Name
The First Center Hospital of Tianjin
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongyang Shen
Facility Name
The First Hospital of Xinjiang Medical University
City
Urumqi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Wen

12. IPD Sharing Statement

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

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