First Stage Results Of A Phase Ii Trial Of Sorafenib Plus Doxorubicin (Sd) In Patients (Pts) With Advanced Hepatocellular Carcinoma (Hcc) Who Progressed (Pod) On Sorafenib (S)

e15147 Background: Retrospective analysis of 14 pts with advanced HCC treated with SD after POD on S, showed a median progression free survival (PFS) and overall survival (OS) of 3.4 and 10.1 months respectively. We theorize SD may have synergistic activity in HCC through inhibition of Raf-1 by S promoting D induced ASK-1 mediated apoptosis. Methods: A single arm phase II study evaluated SD in pts with advanced HCC with RECIST 1.1 radiologic POD on S, ECOG 0-1, Child-Pugh A, and adequate bone marrow, renal, hepatic and cardiac function. The primary endpoint was OS at 6 months (OS6). Statistical plan: two stage design, unacceptable OS6 50%, acceptable OS6 72%, type I and II errors 5 and15% respectively. Secondary endpoints: median PFS, median OS, tolerance to SD, response rate by RECIST 1.1, and associations between previous length of exposure to S and OS and PFS. Results: Starting April 2012, 15 pts were enrolled. Male = 13, Median age 70 years (range 24-82), Median KPS 80%. The median duration of prior S...