OBJECTIVE： To observe the efficacy and safety of Shenling baishu powder combined with irinotecan and raltitrexed in the treatment of advanced colorectal cancer. METHODS： 48 patients with advanced colorectal cancer were randomly divided into control group （25 cases） and observation group （23 cases）. Control group received irinotecan 160 mg/m2， intravenous infusion for 90 min， d1+raltitrexed 3 mg/m2， intravenous infusion， d2. According to different TCM syndrome types， observation group additionally received Shenling baishu powder addition and subtraction of Chinese herbal medicine 2 d before chemotherapy， once a day， for 10 d. 21 d was regarded as a treatment course for chemotherapy and 10 d for TCM， they treated for 2 courses. Clinical efficacy， improvement of TCM syndrome and life quality in 2 groups were observed， and the incidence of adverse reactions was recorded. RESULTS： After treatment， total improvement rate of life quality and improvement rate of TCM syndrome in observation group were significantly higher than control group， the incidence of diarrhea was significantly lower than control group， with statistical significance （P＜0.05）. There was no significant difference in total effective rate， disease control rate， the incidences of diarrhea， liver and kidney function damage and bone marrow suppression in 2 groups （P＞0.05）. CONCLUSIONS： Shenling baishu powder addition and sulotraction combined with irinotecan and raltitrexed can significantly reduce the side effects of chemotherapy， improve clinical symptoms and life quality， and do not increase the incidence of adverse rcactions.