Sorafenib Tosylate Following a Liver Transplant in Treating Patients With Liver Cancer
|Adult Primary Hepatocellular Carcinoma Localized Resectable Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer||Drug: sorafenib tosylate Other: placebo Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Official Title:||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)|
- Recurrence-free survival, evaluated using the new international criteria proposed by the Modified Response Evaluation Criteria in Solid Tumors (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 2 years ]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.
- 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 ]
|Study Start Date:||July 2012|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Experimental: Arm I (sorafenib tosylate)
Patients receive sorafenib tosylate PO BID.
Drug: sorafenib tosylate
Other Names:Other: laboratory biomarker analysis
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO BID.
Other Name: PLCBOther: laboratory biomarker analysis
I. Two-year recurrence free survival (RFS).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624285
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|Principal Investigator:||Ronald Busuttil||Jonsson Comprehensive Cancer Center|