Primary Objective:
1. To define the recommended dose for phase II study of S-1 combined with sorafenib
2. To evaluate the dose-limiting toxicities of the combination therapy
Secondary Objectives:
1. To characterize the pharmacokinetics (PK) of sorafenib and S-1 in the combination
therapy
2. To investigate the impact of genetic polymorphisms of metabolic genes on the PK of
sorafenib and S-1, respectively, as well as on the toxicity profile of the combination.
3. To determine the changes of biomarkers between pre- and post-treatments.