OBJECTIVE： To evaluate therapeutic efficacy and safety of Aidi injection combined with S-1 for advanced gastric cancer systematically， and to provide evidence-based reference. METHODS： Retrieved from CJFD， Wanfang database， VIP， CBM， Cochrane Library， PubMed and EMBase， randomized controlled trials （RCTs） about Aidi injection combined with S-1 （trial group） vs. S-1 alone （control group） for advanced gastric cancer were collected. Meta-analysis was conducted by Rev Man 5.3  software after data extraction and quality evaluation by risk bias evaluation tool of Cochrane Handbook Version 5.1.0. RESULTS： A total of 8 RCT were included， involving 690 patients. Results of Meta-analysis showed that there was no statistical significance in therapeutic efficacy of solid tumor between 2 groups [OR＝1.19，95％CI（0.88，1.61），P＝0.26]. The improvement rate of survival quality[OR＝3.62，95％CI（2.48，5.30），P＜0.001]， immunoglobulin level [CD3：SMD＝1.31，95％CI（1.06，1.56），P＜0.001；CD4：SMD＝1.71，95％CI（1.38，2.04），P＜0.001； CD8：SMD＝－1.46，95％CI（－1.68，－1.23），P＜0.001；CD4/CD8：SMD＝1.45，95％CI（1.14，1.76），P＜0.001] in trial group was significantly higher than control group. The incidence of leukopenia [RR＝0.52，95％CI（0.40，0.68），P＜0.001]， thrombocytopenia [RR＝0.49，95％CI（0.36，0.67），P＜0.001] and gastrointestinal disorder [RR＝0.56，95％CI（0.43，0.71），P＜0.001] in trial group were significantly lower than control group， with statistical significance. CONCLUSIONS： Compared to S-1 alone， S-1 combined with Aidi injection can not significantly improve therapeutic efficacy of solid tumor therapy， but can improve survival quality and immunity of patients， as well as reduce the occurrence of ADR.