OBJECTIVE: To observe the efficacy and safety of Aidi injection combined with oxaliplatin and tegafur gimeracil oteracil potassium in the treatment of advanced colorectal cancer. METHODS:100 patients with advanced colorectal cancer were randomly divided into control group and observation group. Control group was treated with Tegafur gimeracil oteracil potassium capsule,body surface area<1.25 m2,40 mg; while body surface area ≥1.25-<1.50 m2,50 mg and >1.50 m2,60 mg,it was orally taken after breakfast and dinner d1-28,the drug was stopped for 14 d after 28 d treatment+oxaliplatin 85-130 mg/m2 adding into 500 ml of 5% Glucose injection by intravenous infusion for 2 h. Observation group was additionally treated with Aidi injection 100 ml adding into 500 ml of 5% Glucose injection by intravenous infusion, once a day, d1-7, which was repeated every 14 d and was twice. The clinical efficacy, toxicity reactions, improvement of life quality and one-year survival rates in the two groups were observed. RESULTS: There was no statistically significant difference in the total effective rate between 2 groups (P>0.05). The improvement rate of life quality and one-year survival rate in the observation group were significantly higher than control group, the incidence rates of granulocytopenia, platelet decline, oral ulcer and peripheral neurotoxicity in observation group were significantly lower than control group, there was significant difference between 2 groups (P<0.05). CONCLUSIONS: The life qnality and one-year surviral rate of Aidi injection combined with oxaliplatin and tegafur gimeracil oteracil potassium is better than only oxaliplatin combined with tegafur gimeracil oteracil potassium in the treatment of advanced colorectal cancer, with better safety.