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

Phase 2

Completed

• Conditions: Liver Cancer; Hepatocellular Carcinoma
• Interventions: Procedure: LT; Drug: ADV-TK; Drug: ganciclovir

• Registration Number: NCT02202564
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2011-10
• Study Completion: 2013-08
• Status Verified: 2014-07
• Study First Submitted: 2014-07-26
• Study First Submitted QC: 2014-07-28
• Last Update Submitted: 2014-07-28
• Study First Posted: 2014-07-29
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LT+ADV-TK	LT	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.
LT+ADV-TK	ganciclovir	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.
LT	LT	Orthotopic liver transplantation
LT+ADV-TK	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.

Primary Outcome Measures

Name	Time	Method
Overall survival rate	up to 3-year
Recurrence-free survival rate	up to 3-year