Abstract: Objective: To observe the clinical effect of Aidi Injection assisted with SOX regimen on advanced gastric cancer. Methods:A total of 64 patients with advanced gastric cancer were selected and divided into the trial group and the control group according to odd-even numbers randomly,with 32 cases in each group. The control group was treated with SOX regimen, and the trial group was treated with Aidi Injection based on SOX regimen. Both groups were treated for 6 courses, 21 days being a course, and were followed up for 18 months. The clinical effects,levels of tumor markers [serum carbohydrate antigen 724 (CA724), carbohydrate antigen 125 (CA125), carbohydrate antigen 199 (CA199), carcinoembryonic antigen (CEA)], symptom scores, Revised Piper Fatigue Scale (PSR-R), Karnofsky Performance Status (KPS),incidence of adverse reactions,time to progression of tumor (TTP),and median survival time (MST) were compared between the two groups. Results:After 6 courses of treatment,DCR and ORR in the trial group respectively were 93.75% and 68.75%,higher than that of 68.75% and 40.63% in the control group, differences being significant (P<0.05). The serum levels of CA125, CA199, CA724 and CEA in the two groups were decreased when compared with those before treatment, and the serum levels of CA125, CA199 and CEA in the trial group were lower than those in the control group,differences being significant (P<0.05),and there was no significant difference in the comparison of the serum CA724 level between the two groups (P>0.05). The symptom scores and PSR-R scores in the two groups were decreased when compared with those before treatment, and the KPS scores were increased when compared with those before treatment,differences being significant (P<0.05);symptom scores and PSR-R scores in the trial group were lower than those in the control group, and the KPS score was higher than that in the control group, differences being significant (P<0.05). During 6 courses of treatment, excluded liver and kidney function injury, the incidence of thrombocytopenia reduction, hemoglobin reduction, leukopenia, peripheral neurotoxicity adverse reactions in the trial group were lower than those in the control group, differences being significant (P<0.05). After 18 months of follow-up,TTP and MST in the trial group were longer than those in the control group, differences being significant (P<0.05). Conclusion: Aidi Injection assisted with SOX regimen can improve the therapeutic effect on advanced gastric cancer, which can prolong the survival period of patients and reduce the incidence of adverse reactions.