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Completed

NCT Number: NCT01137084

Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids

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

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Key information

Conditions

Immunosuppression Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Hepatocellular Carcinoma Liver Diseases Liver Neoplasms Liver Transplantation Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Post-operative Complications

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

solu medrol

Drug

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

a steroid-free immunosuppression protocol

Drug

receive immunosuppression with Basiliximab(20mg/day,twice following transplantation) and tacrolimus(0.06/kg/d,twice a day) without steroids.

Primary outcomes

  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 outcomes

  1. Postoperative complications

    Time frame: Over 12-month after liver transplantation

    Postoperative complications include acute rejection, infection, metabolic complications and hepatitis B-virus recurrence.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • First Affiliated Hospital of Fujian Medical University
  • Nanchang University
  • Shanghai Changzheng Hospital
  • Zhejiang University

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Jun 4, 2010
Registry last updated
Jun 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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