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

Sponsor

Huazhong University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT02202564

Collaborator

Beijing YouAn Hospital (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cancer Hepatocellular Carcinoma	Procedure: LT Drug: ADV-TK Drug: ganciclovir	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

81 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: LT Orthotopic LT Other Names: liver transplantation Drug: ADV-TK Other Names: adenovirus-thymidine kinase Drug: ganciclovir
Active Comparator: LT Orthotopic liver transplantation	Procedure: LT Orthotopic LT Other Names: liver transplantation

Arm

Intervention/Treatment

Experimental: 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.

Procedure: LT

Orthotopic LT

Other Names:

liver transplantation

Drug: ADV-TK

Other Names:

adenovirus-thymidine kinase

Drug: ganciclovir

Active Comparator: LT

Orthotopic liver transplantation

Procedure: LT

Orthotopic LT

Other Names:

liver transplantation

Outcome Measures

Primary Outcome Measures

Overall survival rate [up to 3-year]
Recurrence-free survival rate [up to 3-year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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