Hepatocellular Carcinoma, Immunosuppression, Liver Transplantation, Post-operative Complications
Conditions
Brief summary
The purpose of this study was to evaluate the safety and efficacy of a steroid-free immunosuppression protocol in Hepatocellular Carcinoma (HCC) patients.
Interventions
DRUGsolu medrol
total dose 20mg/kg, including first dose 10mg/kg, rest of drug given within one weeks after liver transplantation
DRUGa steroid-free immunosuppression protocol
receive immunosuppression with Basiliximab(20mg/day,twice following transplantation) and tacrolimus(0.06/kg/d,twice a day) without steroids.
Sponsors
First Affiliated Hospital of Fujian Medical University
Nanchang University
Zhejiang University
Shanghai Changzheng Hospital
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| patient and graft survival | Over 12-month after liver transplantation | patient and graft survival include surviral rate and recurrence-free survival rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | Over 12-month after liver transplantation | Postoperative complications include acute rejection, infection, metabolic complications and hepatitis B-virus recurrence. |
Countries
China
Outcome results
None listed