Clinical trial NCT01137084: Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunosuppression
Hepatocellular Carcinoma
Liver Transplantation
Post-operative Complications
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Fujian Medical University
name: Nanchang University
name: Zhejiang University
name: Shanghai Changzheng Hospital
First posted: 2010-06-04
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: patient and graft survival
timeFrame: Over 12-month after liver transplantation
Secondary outcomes:
measure: Postoperative complications
timeFrame: Over 12-month after liver transplantation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Zhi-Hai Peng, MD
role: STUDY_CHAIR
References:
citation: Foroncewicz B, Mucha K, Ryszkowska E, Ciszek M, Ziolkowski J, Porowski D, Krawczyk M, Paczek L. Safety and efficacy of steroid-free immunosuppression with tacrolimus and daclizumab in liver transplant recipients: 6-year follow-up in a single center. Transplant Proc. 2009 Oct;41(8):3103-6. doi: 10.1016/j.transproceed.2009.07.082.
citation: Sutherland S, Li L, Concepcion W, Salvatierra O, Sarwal MM. Steroid-free immunosuppression in pediatric renal transplantation: rationale for and [corrected] outcomes following conversion to steroid based therapy. Transplantation. 2009 Jun 15;87(11):1744-8. doi: 10.1097/TP.0b013e3181a5df60.
citation: Li L, Chang A, Naesens M, Kambham N, Waskerwitz J, Martin J, Wong C, Alexander S, Grimm P, Concepcion W, Salvatierra O, Sarwal MM. Steroid-free immunosuppression since 1999: 129 pediatric renal transplants with sustained graft and patient benefits. Am J Transplant. 2009 Jun;9(6):1362-72. doi: 10.1111/j.1600-6143.2009.02640.x. Epub 2009 May 13.
citation: Mastrobuoni S, Ubilla M, Cordero A, Herreros J, Rabago G. Two-dose daclizumab, tacrolimus, mycophenolate mofetil, and steroid-free regimen in de novo cardiac transplant recipients: early experience. Transplant Proc. 2007 Sep;39(7):2163-6. doi: 10.1016/j.transproceed.2007.06.073.
citation: Humar A, Crotteau S, Gruessner A, Kandaswamy R, Gruessner R, Payne W, Lake J. Steroid minimization in liver transplant recipients: impact on hepatitis C recurrence and post-transplant diabetes. Clin Transplant. 2007 Jul-Aug;21(4):526-31. doi: 10.1111/j.1399-0012.2007.00683.x.