Multicenter RCT of ADV-TK Gene Therapy Improving the Outcome of Liver Transplantation for Advanced HCC
Multicenter Randomized Controlled Trial of Adenovirus-mediated Adjuvant Gene Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma
1 other identifier
interventional
180
1 country
11
Brief Summary
Compare the effect of liver transplantation (LT) plus ADV-TK gene therapy versus LT only in advanced primary hepatocellular carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hepatocellular-carcinoma
Started Mar 2013
Longer than P75 for phase_3 hepatocellular-carcinoma
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 8, 2017
CompletedFirst Posted
Study publicly available on registry
October 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 4, 2019
February 1, 2019
6.8 years
October 8, 2017
February 1, 2019
Conditions
Outcome Measures
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.
2-year
Secondary Outcomes (4)
Overall survival, OS
1-year
Overall survival, OS
2-year
Time of the tumor progression,TTP
2-year
Median overall survival time
2-year
Study Arms (2)
LT-only
ACTIVE COMPARATORpatients received orthotopic LT and subsequent immunosuppression therapy
LT+ADV-TK
EXPERIMENTALADV-TK therapy was administered in addition to orthotopic LT and subsequent immunosuppression therapy
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Beijing Youan Hospital
Beijing, Beijing Municipality, 10001, China
301 Military Hospital
Beijing, China
General Hospital of Chinese People's Armed Police
Beijing, China
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 Affiliated Hospital, Zhejiang University
Hangzhou, China
Zhongshan Hospital of Fudan University
Shanghai, China
The First Affiliated Hospital of China Medical University
Shenyang, China
The First Center Hospital of Tianjin
Tianjin, China
The First Hospital of Xinjiang Medical University
Ürümqi, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
October 8, 2017
First Posted
October 18, 2017
Study Start
March 1, 2013
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
February 4, 2019
Record last verified: 2019-02