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Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids

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ClinicalTrials.gov Identifier: NCT01137084
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : June 4, 2010
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

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.

Condition or disease Intervention/treatment Phase
Immunosuppression Hepatocellular Carcinoma Liver Transplantation Post-operative Complications Drug: solu medrol Drug: a steroid-free immunosuppression protocol Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. patient and graft survival [ Time Frame: Over 12-month after liver transplantation ]
    patient and graft survival include surviral rate and recurrence-free survival rate


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



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 General Hospital, Shanghai Jiao Tong University School of Medicine

Publications of Results:
ClinicalTrials.gov Identifier: NCT01137084     History of Changes
Other Study ID Numbers: 20100603
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: June 4, 2010
Last Verified: June 2010

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Postoperative Complications
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Pathologic Processes
Methylprednisolone Hemisuccinate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents