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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huazhong University of Science and Technology
• Collaborator: Beijing YouAn Hospital

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.