Objective:To evaluate the efficacy and safety of trastuzumab combined with FOLFOX regimen in the treatment of human epidermal growth factor receptor-2(HER-2) positive advanced gastric cancer.Methods:70 patients with HER-2 positive advanced gastric cancer were randomly divided into two groups. In the control group, 35 patients underwent FOLFOX chemotherapy. Namely oxaliplatin+leucovorin+5-fluorouracil treatment, on top of which 35 patients in the observation group were treated with trastuzumab. The therapeutic effect, the KPS score, the tumor marker level and the toxic and side effects were compared between the two groups.Results:The objective total effective rate(57.14% vs 40.00%) and the disease controlling rate(80.00% vs 68.57%) in the two groups were statistically significant(P<0.05). After treatment, the KPS score of the observation group was significantly higher than that of the control group(P<0.05);after treatment, the levels of tumor markers(CA724, CA199, CEA) in the observation group were significantly lower than those in the control group(P<0.05);there was no significant difference in the incidence of gastrointestinal reactions, myelosuppression and sensory nerve toxicity between the two groups(P<0.05),the incidence of cardiac toxicity, fever or chills and rash toxicity in the observation group were 14.29%, 22.86% and 25.71%, respectively, which was significantly higher than 2.86%, 5.71% and 2.86% in the control group. Conclusion:Trastuzumab combined with FOLFOX regimen is effective in the treatment of HER-2 positive advanced gastric cancer, which can significantly improve the short-term efficacy and KPS score, but increase the incidence of toxic reactions such as heart toxicity, chills and so on.