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

NCT ID: NCT02202564

Last Updated: 2014-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2013-08-31

Brief Summary

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.

Conditions

Liver Cancer; Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LT+ADV-TK

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.

Group Type: EXPERIMENTAL

LT

Intervention Type: PROCEDURE

Orthotopic LT

ADV-TK

Intervention Type: DRUG

ganciclovir

Intervention Type: DRUG

LT

Orthotopic liver transplantation

Group Type: ACTIVE_COMPARATOR

LT

Intervention Type: PROCEDURE

Orthotopic LT

Interventions

LT

Orthotopic LT

Intervention Type: PROCEDURE

ADV-TK

Intervention Type: DRUG

ganciclovir

Intervention Type: DRUG

Other Intervention Names

liver transplantation; adenovirus-thymidine kinase

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing YouAn Hospital

OTHER

Sponsor Role: collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Ding Ma

Director of the Laboratory of Tumor invasion and metastasis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ding Ma, M.D.

Role: PRINCIPAL_INVESTIGATOR

Huazhong University of Science and Technology

Other Identifiers

LT-02

Identifier Type: -

Identifier Source: org_study_id