LAUSR

e16122Background: Therapeutic approaches and prognosis in cancer depend on the baseline performance status and comorbidities. The first line therapy for iHCC has been sorafenib since 2007, the only FDA-approved medication as first line. Agents with better tolerability are needed since most pts with iHCC have underlying comorbidities. TIVO is an inhibitor of VEGF tyrosine kinase and angiogenesis critical in HCC. Methods: A phase 1b/2 study with iHCC pts with a measurable disease, ECOG ≤ 2, Child-Pugh class A, and no prior systemic therapy was performed. Phase 1b portion followed a modified 3 + 3 design; phase 2 portion was a two-stage, single arm, un-blinded study. Adverse events were categorized based on CTCAE, and tumor imaging was assessed per RECIST. Results: Twenty one (21) eligible pts were enrolled from 3 centers with IRB approval. Eight (8) pts were enrolled in phase 1b with a starting dose of 1 mg once daily for 21days with one week off. The accrual of remaining patients to the phase 2 portion occ...