The exclusion criteria included (1) known hypersensitivity to any of the study drugs, or usage of drugs interacting with S-1; (2) serious concomitant conditions; (3) extensive bone, brain, or meningeal metastasis; (4) another synchronous cancer; (5) surgery within 3 months; (6) participating in other clinical studies; (7) pregnant women; (8) subjects with reproductive potential who were unwilling to use an effective method of contraception.