Status:
UNKNOWN
Multicenter RCT of ADV-TK Gene Therapy Improving the Outcome of Liver Transplantation for Advanced HCC
Lead Sponsor:
Huazhong University of Science and Technology
Collaborating Sponsors:
Beijing YouAn Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03313596
Start Date
March 1 2013
End Date
December 1 2019
Last Update
February 4 2019
Active Locations (11)
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1
Beijing Youan Hospital
Beijing, Beijing Municipality, China, 10001
2
301 Military Hospital
Beijing, China
3
General Hospital of Chinese People's Armed Police
Beijing, China
4
The Third XiangYa Hospital of Central South University
Changsha, China