Abstract: Objective To evaluate the efficacy of high intensity focused ultrasound （HIFU） in combination with S-1 in treatment of advanced pancreatic carcinoma. Methods A total of 120 patients with unresectable advanced pancreatic carcinoma were randomly assigned into group A（n=61） and group B（n=59）. All patients received oral S-1， Oral S-1 was administered at 80mg／day for body surface area（BSA） less than 1.25m²， 100mg／day for BSA 1.25-1.5m²， and 120mg／day for BSA more than 15m2 on days 114 every 3 weeks. Only group A received HIFU in combination with S-1. The response evaluation criteria for solid tumor（RECIST） 1.0 were adopted to evaluate recent curative effect and calculate the response rate（RR） and disease control rate（DCR）. The toxicity was assessed using NCI CTC 3.0. The pain relief rate was analyzed and patients were followed up.
Results All patients were included in the objective response evaluation. The treatment achieved CR in 3 cases， PR in 15 cases， SD in 28 cases and PD in 15 cases of group A and CR in 1 case， PR in 5 cases， SD in 15 cases and PD in 38 cases of group B. The RR and DCR in group A were 295％ and 754％， higher than 102％ and 356％ in group B with significant difference（P＜005）. The median overall survival time was 11.2 months and 6-， 12-months survival rates were 80.0％ and 40.0％ in group A， were superior to 7.9 months， 70.0％ and 10.0％ in group B with significant difference（P＜0.05）. The pain relief rate in group A was 57.4％（35／61）， higher than 20.3％（12／59） in group B with significant difference（P＜0.05）. No significant difference was observed on grade 3-4 toxicities between both groups. No significant difference was observed on grade 1-2 toxicities， including anemia， neutropenia， thrombocytopenia， nausea， diarrhea， handfoot syndrome and neurotoxicity（P＞0.05）. Conclusion The HIFU in combination with S1 shows a favorable benefit and can be well tolerated in patients with advanced pancreatic carcionoma.