Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids

Shanghai Jiao Tong University School of Medicine300 enrolled

Overview

The purpose of this study was to evaluate the safety and efficacy of a steroid-free immunosuppression protocol in Hepatocellular Carcinoma (HCC) patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

300

Conditions

Immunosuppression Hepatocellular Carcinoma Liver Transplantation Post-operative Complications

Interventions

solu medrolDRUG

total dose 20mg/kg, including first dose 10mg/kg, rest of drug given within one weeks after liver transplantation

a steroid-free immunosuppression protocolDRUG

receive immunosuppression with Basiliximab(20mg/day,twice following transplantation) and tacrolimus(0.06/kg/d,twice a day) without steroids.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * All liver transplantation patients with hepatocellular carcinoma in our center between Jan 2005 and Dec 2009 were potentially eligible for enrollment Exclusion Criteria: * the recipient pass away within 3 month following up liver transplantation * Inability to provide written informed consent prior to study entry * acute rejection are treated only with steroids

Locations (1)

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

patient and graft survival

patient and graft survival include surviral rate and recurrence-free survival rate

Time frame: Over 12-month after liver transplantation

Secondary Outcomes

Postoperative complications

Postoperative complications include acute rejection, infection, metabolic complications and hepatitis B-virus recurrence.

Time frame: Over 12-month after liver transplantation

Data from ClinicalTrials.gov

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