OBJECTIVE： To evaluate the clinical efficacy and safety of Shenqi fuzheng injection combined with chemotherapy in the treatment of colorectal cancer. METHODS： Retrieved from PubMed， EMBase， Clinical Trials， Cochrane Library， CJFD， CBM， Wanfang database and VIP， RCTs about Shenqi fuzheng injection combined with chemotherapy （trial group） vs. chemotherapy alone （control group） in the treatment of colorectal cancer were included. Meta-analysis was performed by Rev Man 5.3 statistical software after data extraction and quality evaluation with Cochrane system evaluator manual. RESULTS： A total of 25 RCTs were included， involving 1 987 patients. Results of Meta-analysis showed that objective remission rate of trial group was significantly higher than control group [RR＝1.19，95％CI（1.02，1.39），P＝0.02]； the improvement of survival quality was significantly better than control group [RR＝1.72，95％CI（1.49， 1.99），P＜0.001]； CD4+/CD8+ was significantly higher than control group [MD＝0.40，95％CI（0.29， 0.50），P＜0.001]； the incidence of gastrointestinal reaction was significantly higher than control group [RR＝0.59，95％CI（0.52， 0.68），P＜0.001]； the incidence of liver and renal injury was significantly lower than control group [RR＝0.52，95％CI（0.41，0.67），P＜0.001] ，with statistical significance. CONCLUSIONS： Shenqi fuzheng injection combined with chemotherapy can improve objective remission rate of colorectal cancer patients， survival quality and immune function， and reduce the occurrence of toxic reation.