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

Huazhong University of Science and Technology

Status and phase: Unknown; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Drug: ADV-Tk; Procedure: LT

Study type: Interventional

Funder types: Other

Identifiers

NCT03313596

LT-03

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

LT-only

Active Comparator group

Description:

patients received orthotopic LT and subsequent immunosuppression therapy

Treatment:

Procedure: LT

LT+ADV-TK

Experimental group

Description:

ADV-TK therapy was administered in addition to orthotopic LT and subsequent immunosuppression therapy

Treatment:

Procedure: LT

Drug: ADV-Tk