Preliminary Results for the Double-dose Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma

Huazhong University of Science and Technology

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma; Liver Cancer

Treatments: Drug: ADV-TK; Procedure: LT; Drug: ganciclovir

Study type: Interventional

Funder types: Other

Identifiers

NCT02202564

LT-02

Details and patient eligibility

About

HCC patients with tumors >5 cm in diameter, regardless of involvement in the intrahepatic and extrahepatic portal branches participated in the study. Patients were randomized allocated in liver transplantation (LT) only group and LT plus ADV-TK therapy group. All patients received orthotopic liver transplantation; in the LT plus ADV-TK group, ADV-TK therapy was delivered to patients twice.

Enrollment: 81 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18～70 years of age (Male and Female).
• Clinical diagnosis of advanced hepatocellular carcinoma who could accept liver transplantation
• Patients who had unresectable HCC >5 cm and no metastasis in lungs and bones were eligible to participate in this study. Tumor involvement in the intrahepatic and extrahepatic portal branches was not considered to be an exclusion criterion.
• No prior chemotherapy, radiation therapy, targeted therapy or other kind of biological treatment within 4 weeks.
• Provide written informed consent

Exclusion criteria

• Metastasis in lungs and bones
• Invasion in main vescular.
• Contraindications of liver transplantation
• Contraindications of operation of other organ system
• Hypersensitivity to adenovirus, GCV or similar drugs
• Accept clinical trials of other drugs
• Immunological deficit
• Active pregnancy
• Unable or unwilling to sign informed consents

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

LT+ADV-TK

Experimental group

Description:

Liver transplantation and double-dose ADV-TK/ganciclovir administration The first ADV-TK dose was administered before closing the peritoneal layer; the second ADV-TK dose was administered 2 months after LT; ganciclovir was slowly administered 36 hours after LT and twice daily for 14 days.

Treatment:

Drug: ganciclovir

Procedure: LT

Drug: ADV-TK

LT

Active Comparator group

Description:

Orthotopic liver transplantation

Treatment:

Procedure: LT