Abstract: Objective To determine the clinical toxicity and antitumor effect of a chemotherapy regimen with TS1 and cisplatin in patients with inoperable local or metastatic advanced gastric cancer. Methods One hundred and seven patients were included in this study. Oral TS1（80mg/m²） was administered daily for 14 consecutive days and cisplatin（25mg/m²） was administered on days 1-3 of each 21-day cycle. Results The overall response rate was 34.78% in the observed group and 9.3% in the control group. The improving rate was 56.52% in the observed group and 23.26% in the control group. The main toxicity occurred in bone marrow and digestive tract. The incidence rate of leucopenia and thrombocytopenia was similar in the two groups,but the incidence rate of vomiting was higher in the control group than in the observed group. Conclusion This regimen with TS1 and cisplatin is generally well-tolerated and has substantial antitumor activity.