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Sorafenib Tosylate Following a Liver Transplant in Treating Patients With Liver Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Sorafenib Tosylate Following a Liver Transplant in Treating Patients With Liver Cancer

A Phase II Randomized Multicenter Placebo-Controlled Blinded Study of Sorafenib Adjuvant Therapy in High Risk Orthotopic Liver Transplant (OLT) Recipients With Hepatocellular Carcinoma (HCC)

NCT01624285•Jonsson Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if sorafenib (sorafenib tosylate) is a safe and effective treatment option for preventing liver cancer in high risk patients following liver transplantation. Liver transplantation is a treatment option for liver cancer patients, but despite transplantation, the liver cancer can recur in the new, transplanted liver. It is not known whether sorafenib is effective in preventing cancer recurrence in high risk patients following liver transplantation

Detailed Description

PRIMARY OBJECTIVES: I. Two-year recurrence free survival (RFS). SECONDARY OBJECTIVES: I. One-year recurrence free survival. II. Overall survival (OS). III. Safety. IV. Impact of drug-drug interactions (i.e. immunosuppression agents). V. Impact of biomarkers (alpha-fetoprotein \[AFP\], protein-induced by vitamin K absence or antagonist II \[PIVKA II\]). VI. Effects of therapy on wound healing. VII. Impact of hepatitis C viral recurrence. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive sorafenib tosylate orally (PO) twice daily (BID). ARM II: Patients receive placebo PO BID. In both arms treatment continues for 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 2 years.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have hepatocellular carcinoma (HCC) with one of the following on explant: microvascular/macrovascular invasion, tumor outside of Milan criteria, poor tumor differentiation; patients with macrovascular invasion on explant pathology will be stratified
•\* Additionally, the following will be included
•\*\* Patients with elevated surrogate markers (AFP \> 500 or PIVKA \> 400) pre transplant and with biopsy proven HCC prior to orthotopic liver transplantation (OLT) or on explant
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
•Patients with a life expectancy \> 12 weeks
•Patients must have completed prednisone taper within 6 weeks post OLT
•Patients must be enrolled between 6 to 12 weeks post OLT
•Cadaveric donors only (no living donor liver transplantation \[LDLT\] or donor after cardiac death transplantation \[DCDT\])
•No sorafenib prior to inclusion in the study
•Platelet count \> 50 x 10\^9/L
+14 more criteria

Exclusion Criteria

•Significant ongoing immunologic rejection based on pathology and clinical diagnosis (from time of transplant until randomization)
•Use of T cell depleting agents for prevention or treatment of rejection at any point prior to or after enrollment in the study
•Patient with documented evidence of metastatic disease
•100% tumor necrosis on explant pathology
•Use of mammalian target of rapamycin (mTOR) inhibitors prior to transplant and as post-transplant immunosuppression
•Use of alemtuzumab
•Living donor liver transplant (LDLT) or donation after cardiac death transplant (DCDT)
•Human immunodeficiency virus (HIV) positive patients
•Hepatitis C virus (HCV) recurrence at the time of randomization
•Use of direct acting antivirals for HCV recurrence
+36 more criteria

Locations (21)

University of Alabama

Birmingham, Alabama, United States

Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

University of Colorado

Denver, Colorado, United States

Mount Sinai Hospital

Hartford, Connecticut, United States

Lombardi Comprehensive Cancer Center at Georgetown University

Washington D.C., District of Columbia, United States

Emory University

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Lahey Clinic Medical Center

Burlington, Massachusetts, United States

Key Dates

Start Date

July 16, 2012

Primary Completion Date

February 1, 2023

Completion Date

February 1, 2023

Last Updated

December 14, 2023

Enrollment

ACTUAL participants

Conditions

Adult Primary Hepatocellular CarcinomaLocalized Resectable Adult Primary Liver CancerLocalized Unresectable Adult Primary Liver CancerRecurrent Adult Primary Liver Cancer

Interventions

sorafenib tosylate

DRUG

placebo

OTHER

laboratory biomarker analysis

OTHER

Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Sorafenib Tosylate Following a Liver Transplant in Treating Patients With Liver Cancer

Inclusion Criteria

Exclusion Criteria

Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer

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