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Status unknownNCT03313596Updated Feb 4, 2019

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

A Phase 3 interventional study of ADV-Tk and LT in Hepatocellular Carcinoma, sponsored by Huazhong University of Science and Technology. Status unknown at 11 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-02-04.

Sponsored by Huazhong University of Science and Technology · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Hepatocellular Carcinoma
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Active comparator
    LT-only

    patients received orthotopic LT and subsequent immunosuppression therapy

    Procedure: LT

  • Experimental
    LT+ADV-TK

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

    Drug: ADV-Tk · Procedure: LT

Interventions

  • DrugADV-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.

  • ProcedureLT

    Orthotopic LT and subsequent immunosuppression therapy

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2-year

Secondary outcomes

  1. Overall survival, OS

    OS was measured from the day of liver transplantation to death.

    Time frame: 1-year

  2. Overall survival, OS

    OS was measured from the day of liver transplantation to death.

    Time frame: 2-year

  3. Time of the tumor progression,TTP

    TTP was the median period from the day of liver transplantation to objective recurrence (MRI or CT).

    Time frame: 2-year

  4. Median overall survival time

    Time frame: 2-year

06

Study locations

11 of 11 sites recruiting
  • Beijing Youan Hospital
    Beijing, Beijing 10001, China
    • Ning Li, Dr · Contact
    Recruiting
  • 301 Military Hospital
    Beijing, China
    • Jiahong Dong · Contact
    Recruiting
  • General Hospital of Chinese People's Armed Police
    Beijing, China
    • Yunjin Zang · Contact
    Recruiting
  • The Third XiangYa Hospital of Central South University
    Changsha, China
    • Qifa Ye · Contact
    Recruiting
  • West China Hospital of Sichuan University
    Chengdu, China
    • Lvnan Yan · Contact
    Recruiting
  • The Third Affiliated Hospital,Sun Yat-sen University
    Guangzhou, China
    • Guihua Chen · Contact
    Recruiting
  • The First Affiliated Hospital, Zhejiang University
    Hangzhou, China
    • Shusen Zheng · Contact
    Recruiting
  • Zhongshan Hospital of Fudan University
    Shanghai, China
    • Jia Fan · Contact
    Recruiting
  • The First Affiliated Hospital of China Medical University
    Shenyang, China
    • Yongfeng Liu · Contact
    Recruiting
  • The First Center Hospital of Tianjin
    Tianjin, China
    • Zhongyang Shen · Contact
    Recruiting
  • The First Hospital of Xinjiang Medical University
    Urumqi, China
    • Hao Wen · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT03313596
Lead sponsor
Huazhong University of Science and Technology
Collaborators
Beijing YouAn Hospital
Responsible party
Ding Ma (Director, Huazhong University of Science and Technology) — Principal investigator
First posted
Oct 18, 2017
Start date
Mar 2013
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Feb 4, 2019

Study contacts

Danhui Weng, Dr.
Contact
weng.dh@gmail.com
027-83663351

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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