4026 Background: We report the second interim analysis of START. Methods: START is a phase II, multicenter, open-label, single-arm study being conducted in Asia Pacific. Patients with unresectable, intermediate-stage HCC (BCLC B), and who are candidates for TACE are eligible. Patients receive TACE with lipiodol and doxorubicin (30-60 mg), followed by embolization with absorbable particles. Sorafenib 400mg bid is given continuously, with dose interruptions 4 days before and after TACE, which is performed every 6-8 weeks. Tumor response is assessed every 4 weeks after every TACE. Patients continue sorafenib until disease progression or unacceptable toxicity, even after stopping TACE due to complete response (CR) or inability to continue to receive TACE. The primary endpoint is safety/tolerability. Secondary endpoints include progression-free survival, time to progression, overall survival, and number of TACE cycles. Results: 63 patients were evaluable for safety, and 50 for efficacy. For analysis of efficac...