Abstract: Objective: To evaluate the efficacy,side-effects and quality of life in the advanced gastric cancer patients treated by paclitaxel (PTX) plus tegafur (FT-207) and leucovorin (LV) with or without calf spleen extraction injection.Methods: Forty-three eligible patients were randomly assigned to the treatment group and control group.In the treatment group,20 patients were treated with PTX+FT-207+LV+calf spleen extraction injection.In the control group,the regimen was the same as in the treatment group except calf spleen extraction injection.Results: Overall response rates were 65.0% and 34.8% (P<0.05) in the treatment group and control group,respectively.The median survival time was 12 months versus 10 months (P>0.05) in the treatment group and control group,respectively.The 1-year survival rate for treatment group and control group was 60.0% versus 21.7% (P<0.05),respectively.The clinical efficacy and the frequence of leukocyte reduction were better in the treatment group than in control group,the quality of life were improved more significantly than those in control group (P<0.05).Conclusions: Calf spleen extraction injection plus PTX+FT-207+LV regimen can improve the efficacy of the treatment,reduce the chemotherapy related toxicities of digestive tract and bone marrow,improve the quality of life and the tolerance of chemotherapy of advanced gastric cancer patients.