Abstract: Abstract:Objective To evaluate the efficacy and safety of combination therapy with YH-16, Docetaxel and Cisplatin in advanced esophageal squamous cell carcinoma as a first-line regimen. Methods Twenty-seven patients with histopathologically verified squamous cell carcinoma of the esophagus, with 16 patients receiving DOC／DDP combination chemotherapy and the other 11 patients receiving YH-16／DOC／DDP combination chemotherapy.In the DOC／DDP group patients received DOC 60mg/m2 1h infusion on day 1, DDP 30mg/m2 from day 1 to 3 2h infusion; YH-16／DOC／DDP group received DOC 60mg/m2 1h infusion on day 1, DDP 30mg/m2 from day 1 to day 3 2h infusion; YH-16 7.5 mg/m2 from day 1 to day 14 during 3~4h infusion.Treatment cycles were repeated every 3 weeks.Efficacy was evaluated every 2 circles according to patients RECIST standard, toxicities were assessed based on CTCAE3.0 after each circle. Results In DOC／DDP group, 6 patients partial remission (PR)(37.5%), the overall response rate was 37.5%(CR+PR).The median time to disease progress(TTP) was 142 days and median overall survival time(OS) was 310.5 days; while in YH-16／DOC／DDP group one patient was observed complete remission CR(9%), 4 patients partial remission (PR)(36.4%), the overall response rate was 45.4%; The median time to disease progress(TTP) was 210days, and median overall survival time(OS) was 371 days.TTP and OS did not differ significantly between the two regimens.In DOC／DDP group and YH-16／DOC／DDP group there were grade 3~4 hematological toxicity: leucopenia(44% vs. 45%), neutropenia (38% vs. 27%) and febrile neutropenia （6% vs. 9%）.Nohematological toxicity consisted mainly of grade 1~2 nausea／vomiting（50% vs. 45%）.Furthermore, no treatment-related deaths were observed. Conclusion YH-16／DOC／DDP combination as a first-line regimen for advanced esophageal squamous cell carcinoma did not improve TTP and OS.