Clinical trial NCT03313596: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Beijing YouAn Hospital
First posted: 2017-10-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Progression-free survival, PFS
timeFrame: 2-year
Secondary outcomes:
measure: Overall survival, OS
timeFrame: 1-year
measure: Overall survival, OS
timeFrame: 2-year
measure: Time of the tumor progression,TTP
timeFrame: 2-year
measure: Median overall survival time
timeFrame: 2-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Youan Hospital
state: Beijing
city: Beijing
country: China
facility: 301 Military Hospital
city: Beijing
country: China
facility: General Hospital of Chinese People's Armed Police
city: Changsha
country: China
facility: The Third XiangYa Hospital of Central South University
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Guangzhou
country: China
facility: The Third Affiliated Hospital,Sun Yat-sen University
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
city: Tianjin
country: China
facility: The First Center Hospital of Tianjin
city: Urumqi
country: China
facility: The First Hospital of Xinjiang Medical University
Study officials:
References: