Phase II study of TS-1, CPT-11 and Bevacizumab combination chemotherapy in patients with metastatic colon cancer

Interventions: CPT-11 80 mg/m2 is administered with 90 min intravenous injection on days 1, 15 repeated every 5 weeks. TS-1 80 mg/m2/day is administered orally for 4 consecutive weeks every 6 weeks. Bevacizumab 7mg/kg is administered with 30-90 min intravenous injection on days 1, 15.
Primary outcome(s): Overall response rate
Study Design: Single arm Non-randomized

干预方案：伊立替康（CPT-11）以80 mg/m²剂量，于第1、15天进行90分钟静脉输注，每5周重复一个治疗周期；替吉奥（TS-1）以80 mg/m²/日剂量连续口服给药4周，每6周重复一个治疗周期；贝伐珠单抗（Bevacizumab）以7mg/kg剂量，于第1、15天进行30~90分钟静脉输注。主要研究终点：总缓解率。试验设计：单臂非随机试验。