Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids

This study has been completed.
Sponsor:
Collaborators:
First Affiliated Hospital of Fujian Medical University
Nanchang University
Zhejiang University
Shanghai Changzheng Hospital
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01137084
First received: June 3, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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


Condition Intervention
Immunosuppression
Hepatocellular Carcinoma
Liver Transplantation
Post-operative Complications
Drug: solu medrol
Drug: a steroid-free immunosuppression protocol

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

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • patient and graft survival [ Time Frame: Over 12-month after liver transplantation ] [ Designated as safety issue: No ]
    patient and graft survival include surviral rate and recurrence-free survival rate


Secondary Outcome Measures:
  • Postoperative complications [ Time Frame: Over 12-month after liver transplantation ] [ Designated as safety issue: Yes ]
    Postoperative complications include acute rejection, infection, metabolic complications and hepatitis B-virus recurrence.


Estimated Enrollment: 300
Study Start Date: January 2005
Study Completion Date: December 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: a steroid immunosuppression protocol Drug: solu medrol
total dose 20mg/kg, including first dose 10mg/kg, rest of drug given within one weeks after liver transplantation
Active Comparator: a steroid-free immunosuppression protocol
without steroid
Drug: 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137084

Locations
China, Shanghai
Shanghai First People's Hospital
Shanghai, Shanghai, China, 200080
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
First Affiliated Hospital of Fujian Medical University
Nanchang University
Zhejiang University
Shanghai Changzheng Hospital
Investigators
Study Chair: Zhi-Hai Peng, MD Shanghai First People's Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01137084     History of Changes
Other Study ID Numbers: 20100603
Study First Received: June 3, 2010
Last Updated: June 3, 2010
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Postoperative Complications
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014