Objective: To observe the efficacy, side effects and impact on the quality of life of Aidi Injection® combined with leucovorin calcium/ 5-fluorouracil/ oxaliplatin (FOLFOX4 regimen) in the treatment of advanced colorectal cancer patients. Methods: A consecutive cohort of 100 patients were divided into two groups: the experimental group was treated with Aidi injection and FOLFOX4 while the control group was only administered FOLFOX4. After more than two courses of treatment, efficacy, quality of life and side effects were evaluated. Results: The response rate of experimental group was not significantly different with that of control group (P>0.05), but differences were significant in clinical benefit response and KPS score. Iin addition, gastrointestinal reaction and the incidence of leukopenia were lower than that of control group (P<0.05). Conclusions: Aidi injection combined with FOLFOX4 is associated with reduced toxicity of chemotherapy, enhanced clinical benefit response and improved quality of life of patients with advanced colorectal cancer. Aidi injection deserves to be further investigated by randomized control clinical trails.