Abstract:Objective: To evaluate the recent curative efficacy and security of High intensity focused ultrasound (HIFU) in combination with chemotherapy(PFC) in patients with advanced gastric carcinoma. Method: Sixty patients with measurable advanced gastric carcinoma,proved pathologically, were divided into Group A and Group B. Group A: Patients were treated by HIFU(FEP-BY01) in combination with chemotherapy(PFC, paclitaxel, cisplatin and 5-fluorouracil). Group B: Patients were treated with the single regime of PFC. Results: All cases could be evaluated. In group A, 5 patients achieved complete response, 17 patients achieved partial response,and a response rate was 73.3 %. The stable disease(SD) and the inefficiency all were 13.3 % (4/30) respectively, and msurvival time(MST)was 13.9 months. In group B, 2 patients achieved complete response, 14 patients achieved partial response, and a response rate was 53.3%. The stable disease(SD) was 23.3%(7/30). The inefficiency all were 23.3%(7/30) respectively, and median survival time was 9.6 months. There was significant difference between two groups' MST( P < 0.05). Major toxicities included bone marrow depression,nausea, vomiting and alopecia, without significant differences between two groups( P > 0.05). Conclusion: This study shows that HIFU in combination with chemotherapy(PFC) was a new efficent and secure therapy for the patients with advanced gastric carcinoma. It was observed that the MST was prolonged. Prospective trials should be warranted to determine the result.