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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
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
...and 11 more locations
Recurrence-free survival, evaluated using the new international criteria proposed by the Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Committee
Estimated using the Kaplan-Meier method. Compared between the drug verses placebo groups using the unstratified log rank test. Hazard rates, hazard rate ratios and median times to recurrence (or 25 percentiles if median time is not reached) and their corresponding 95% confidence bounds will be reported. A secondary analysis will also be presented stratified by macro versus non-macro status, the most important potential covariate.
Time frame: Defined as the time from randomization to the first documented disease recurrence by radiological assessment or death due to any cause whichever occurs first, assessed at 2 years
Overall survival
Time frame: From randomization to the date of death or the last date the subject was known to be alive, assessed up to 2 years after completion of study treatment
Recurrence-free survival, evaluated using the new international criteria proposed by the mRECIST Committee
Time frame: Defined as the time from randomization to the first documented disease recurrence by radiological assessment or death due to any cause whichever occurs first, assessed at 1 year
Adverse events assessed in terms of seriousness, severity, and relationship to the study material according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: Assessed up to 2 years
Impact of drug-drug interactions
Time frame: Assessed up to 2 years after completion of study treatment
Impact of biomarkers (AFP and PIVKA II)
Time frame: Assessed up to 2 years after completion of study treatment
Time to wound healing
Time frame: Assessed up to 2 years after completion of study treatment
Time to first HCV viral recurrence
Time frame: Assessed up to 2 years after completion of study treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.