Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids

Hepatocellular Carcinoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137084
• Other study ID #: 20100603
• Status: Completed
• Phase: N/A
• First received: June 3, 2010
• Last updated: June 3, 2010
• Start date: January 2005
• Est. completion date: December 2009

Study information

• Verified date: June 2010
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2009
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Immunosuppression
• Liver Transplantation
• Post-operative Complications
• Postoperative Complications

Intervention

Drug:
• solu medrol
total dose 20mg/kg, including first dose 10mg/kg, rest of drug given within one weeks after liver transplantation
• a steroid-free immunosuppression protocol
receive immunosuppression with Basiliximab(20mg/day,twice following transplantation) and tacrolimus(0.06/kg/d,twice a day) without steroids.

Locations

Country	Name	City	State
China	Shanghai First People's Hospital	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	First Affiliated Hospital of Fujian Medical University, Nanchang University, Shanghai Changzheng Hospital, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (5)

Foroncewicz B, Mucha K, Ryszkowska E, Ciszek M, Ziólkowski 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. Trans — View 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. — View 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 T — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient and graft survival	patient and graft survival include surviral rate and recurrence-free survival rate	Over 12-month after liver transplantation	No
Secondary	Postoperative complications	Postoperative complications include acute rejection, infection, metabolic complications and hepatitis B-virus recurrence.	Over 12-month after liver transplantation	Yes