Sorafenib Tosylate Following a Liver Transplant in Treating Patients With Liver Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Adult Primary Hepatocellular Carcinoma
- Localized Resectable Adult Primary Liver Cancer
- Localized Unresectable Adult Primary Liver Cancer
- Recurrent Adult Primary Liver Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT01624285
- Collaborators
- Bayer
- Investigators
- Principal Investigator: Ronald Busuttil Jonsson Comprehensive Cancer Center