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

Phase 3

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: ADV-Tk; Procedure: LT

• Registration Number: NCT03313596
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2017-10-08
• Study First Submitted QC: 2017-10-13
• Study First Posted: 2017-10-18
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LT+ADV-TK	LT	ADV-TK therapy was administered in addition to orthotopic LT and subsequent immunosuppression therapy
LT-only	LT	patients received orthotopic LT and subsequent immunosuppression therapy
LT+ADV-TK	ADV-Tk	ADV-TK therapy was administered in addition to orthotopic LT and subsequent immunosuppression therapy

Primary Outcome Measures

Name	Time	Method
Progression-free survival, PFS	2-year	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

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

Trial Locations

Locations (11)

The Third XiangYa Hospital of Central South University; 🇨🇳 Changsha, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, China

The Third Affiliated Hospital,Sun Yat-sen University; 🇨🇳 Guangzhou, China

The First Hospital of Xinjiang Medical University; 🇨🇳 Urumqi, China

Beijing Youan Hospital; 🇨🇳 Beijing, Beijing, China

The First Center Hospital of Tianjin; 🇨🇳 Tianjin, China

General Hospital of Chinese People's Armed Police; 🇨🇳 Beijing, China

301 Military Hospital; 🇨🇳 Beijing, China

The First Affiliated Hospital, Zhejiang University; 🇨🇳 Hangzhou, China

Zhongshan Hospital of Fudan University; 🇨🇳 Shanghai, China

The First Affiliated Hospital of China Medical University; 🇨🇳 Shenyang, China