Abstract: ObjectiveTo evaluate the efficacy and safety of the combination therapy of Irinotecan and Cisplatin as a second-line regimen for patients with advanced gastric cancer. MethodsTwenty-eight patients with advanced gastric cancer were verified with histopathology and iconography, who received irinotecan and Cisplatin as a second-line regimen were evaluated. The combination therapy consisted of intravenous administration of irinotecan 70 mg/m2during 1 h, on day 1and 8, followed by Cisplatin 70 mg/m2 during 2 h on day 1, and repeated every 3 weeks. Efficacy was evaluated every 6 weeks (2 circles) according to RECIST standard, toxicities were assessed based on CTCAE3.0 after each circle. The follow up period was 30 months, and the survival analyses was all estimated using the Kaplan-Meier method. Results All of the 28 patients were assessable for response. In the study, 1 patient experienced complete remission (CR)(3.6%), 11 patients partial remission (PR)(39.3%), 6 patients stable disease (SD)(21.4%), and 10 patients showed progressive disease (PD)(35.7%). The overall response rate was 42.9%(CR+PR). The median time to disease progress(TTP) was 5 months(95% confidence interval ［CI］, range 3.0～24 months), and the median overall survival time (OS) was 8 months(95% confidence interval ［CI］, range 5.0～30.0 months). 3～4 grade hematological adverse events were: neutropenia 35.7%, thrombocytopenia 25%, anemia 14.3%. 3～4 grade nonhematological adverse events were: nausea /vomitting 35.7%; diarrhea 17.8%.Furthermore, no treatment-related deaths were observed. Conclusion Combination therapy of irinotecan with nedaplatin in advanced gastric cancer as a second-line regimen is effective recently, safe and well tolerated.