NCT01137084

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2010

Completed
Last Updated

June 4, 2010

Status Verified

June 1, 2010

Enrollment Period

3 years

First QC Date

June 3, 2010

Last Update Submit

June 3, 2010

Conditions

ImmunosuppressionHepatocellular CarcinomaLiver TransplantationPost-operative Complications

Outcome Measures

Primary Outcomes (1)

  • patient and graft survival

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

    Over 12-month after liver transplantation

Secondary Outcomes (1)

  • Postoperative complications

    Over 12-month after liver transplantation

Study Arms (2)

a steroid immunosuppression protocol

ACTIVE COMPARATOR
Drug: solu medrol

a steroid-free immunosuppression protocol

ACTIVE COMPARATOR

without steroid

Drug: a steroid-free immunosuppression protocol

Interventions

solu medrolDRUG

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

a steroid immunosuppression protocol
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.

a steroid-free immunosuppression protocol

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All liver transplantation patients with hepatocellular carcinoma in our center between Jan 2005 and Dec 2009 were potentially eligible for enrollment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Related Publications (5)

  • 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.

    PMID: 19857686RESULT

  • 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.

    PMID: 19502970RESULT

  • 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.

    PMID: 19459814RESULT

  • 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.

    PMID: 17889125RESULT

  • 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.

    PMID: 17645714RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Zhi-Hai Peng, MD

    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2010

First Posted

June 4, 2010

Study Start

January 1, 2005

Primary Completion

January 1, 2008

Study Completion

December 1, 2009

Last Updated

June 4, 2010

Record last verified: 2010-06

Locations

CN(1)