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Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00355862
Recruitment Status : Completed
First Posted : July 25, 2006
Last Update Posted : July 30, 2014
Information provided by:
University of Regensburg

Brief Summary:
The purpose of this study is to determine the safety and efficacy of sirolimus-based immunosuppressive therapy in patients following orthotopic liver transplantation (OLT) for hepatocellular carcinoma (HCC), with regard to HCC recurrence-free patient survival.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: CNI, MMF, Steroids, Aza etc. (mTOR inhibitor free) Drug: Sirolimus Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 525 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomised, Open-labeled, Trial Comparing Sirolimus-Containing Versus mTOR-Inhibitor-Free Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma
Study Start Date : January 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Center specific immunosuppressive regimen (mTOR inhibitor free)
Drug: CNI, MMF, Steroids, Aza etc. (mTOR inhibitor free)
center specific therapeutic regimen without mTOR inhibition
Other Names:
  • Cyclosporine
  • Tacrolimus
  • Azathioprine
  • MMF
  • Prednisolone
  • etc

Experimental: 2
Sirolimus containing regimen
Drug: Sirolimus
Sirolimus based immunosuppression
Other Name: Rapamune

Primary Outcome Measures :
  1. Recurrence free survival [ Time Frame: 5 year follow up after last patient in ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 18 years and older
  2. Histologically proven HCC before randomisation
  3. Signed, written informed consent

Exclusion Criteria:

  1. Multiple-organ recipients.
  2. Known hypersensitivity to sirolimus or its derivatives.
  3. Hyperlipidemia refractory to optimal medical management. (cholesterol >300 mg/dL; triglycerides >350 mg/dL).*
  4. Evidence of significant local or systemic infection.
  5. Known HIV-positive patients.*
  6. Platelets <75,000/cubic mm.*
  7. Women of child-bearing potential not willing to take contraception.
  8. Patients with non-HCC malignancies within the past 5 years,excluding successfully treated squamous cell carcinoma and basal cell carcinoma of the skin.
  9. Extrahepatic HCC tumor manifestation
  10. Patients with a psychologic, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
  11. Patients under guardianship (e.g. individuals who are not able to freely give their informed consent).

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 identifier (NCT number): NCT00355862

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Regensburg University
Regensburg, Bavaria, Germany, 93053
Sponsors and Collaborators
University of Regensburg
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Study Chair: Edward K Geissler, Prof. PhD Regensburg University Medical Center, Head of Experimental Surgery
Study Director: Hans J Schlitt, Prof. MD. FACS FRACS FRCS MHM Regensburg University Medical Center, Director of Surgical Department
Principal Investigator: Andreas A Schnitzbauer, MD Regensburg University Hospital

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Geissler EK, Schnitzbauer AA, Zülke C, Lamby PE, Proneth A, Duvoux C, Burra P, Jauch KW, Rentsch M, Ganten TM, Schmidt J, Settmacher U, Heise M, Rossi G, Cillo U, Kneteman N, Adam R, van Hoek B, Bachellier P, Wolf P, Rostaing L, Bechstein WO, Rizell M, Powell J, Hidalgo E, Gugenheim J, Wolters H, Brockmann J, Roy A, Mutzbauer I, Schlitt A, Beckebaum S, Graeb C, Nadalin S, Valente U, Turrión VS, Jamieson N, Scholz T, Colledan M, Fändrich F, Becker T, Söderdahl G, Chazouillères O, Mäkisalo H, Pageaux GP, Steininger R, Soliman T, de Jong KP, Pirenne J, Margreiter R, Pratschke J, Pinna AD, Hauss J, Schreiber S, Strasser S, Klempnauer J, Troisi RI, Bhoori S, Lerut J, Bilbao I, Klein CG, Königsrainer A, Mirza DF, Otto G, Mazzaferro V, Neuhaus P, Schlitt HJ. Sirolimus Use in Liver Transplant Recipients With Hepatocellular Carcinoma: A Randomized, Multicenter, Open-Label Phase 3 Trial. Transplantation. 2016 Jan;100(1):116-25. doi: 10.1097/TP.0000000000000965.
Schnitzbauer AA, Zuelke C, Graeb C, Rochon J, Bilbao I, Burra P, de Jong KP, Duvoux C, Kneteman NM, Adam R, Bechstein WO, Becker T, Beckebaum S, Chazouillères O, Cillo U, Colledan M, Fändrich F, Gugenheim J, Hauss JP, Heise M, Hidalgo E, Jamieson N, Königsrainer A, Lamby PE, Lerut JP, Mäkisalo H, Margreiter R, Mazzaferro V, Mutzbauer I, Otto G, Pageaux GP, Pinna AD, Pirenne J, Rizell M, Rossi G, Rostaing L, Roy A, Turrion VS, Schmidt J, Troisi RI, van Hoek B, Valente U, Wolf P, Wolters H, Mirza DF, Scholz T, Steininger R, Soderdahl G, Strasser SI, Jauch KW, Neuhaus P, Schlitt HJ, Geissler EK. A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma. BMC Cancer. 2010 May 11;10:190. doi: 10.1186/1471-2407-10-190.

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Responsible Party: Edward K Geissler, Regensburg University Identifier: NCT00355862    
Other Study ID Numbers: SiLVER05
EudraCT Number:
First Posted: July 25, 2006    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2009
Keywords provided by University of Regensburg:
HCC-recurrence free survival
Liver transplant recipients
HCC recurrence free survival
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antineoplastic Agents