Recruitment

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