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【目的】比较改良IRIS方案与经典FOLFIRI方案治疗晚期结直肠癌（mCRC）的近期疗效及其毒副反应。【方法】选择2011年3月至2012年9月本院收治的64例mCRC患者，将其随机分配为观察组（ n＝32）和对照组（ n ＝32）。观察组接受改良IRIS方案伊立替康（CPT‐11）联合滞后2 d服用替吉奥（S‐1），对照组接受标准FOLFIRI方案，观察两组化疗的毒副反应并评价化疗疗效。【结果】①疗效：两组患者RR、DCR无显著性差异（ P ＞0．05）。②毒副反应：两组方案最常见为骨髓抑制、厌食、疲劳、恶心呕吐、腹泻等，多为Ⅰ～Ⅱ度，Ⅲ度毒性反应少见，无Ⅳ度不良反应发生。其中对照组Ⅲ度粒细胞减少、恶心呕吐较实验组更严重，差别有统计学意义（P ＜0．05）。③生存期：实验组和对照组的无进展生存期为8．2个月和7．9个月，中位生存期为21．8个月和21．4个月，差异均无统计学意义（ P ＞0．05）。【结论】改良IRIS方案治疗mCRC近期临床疗效较好，毒副反应可以耐受，生存期不亚于采用标准FOLFIRI方案治疗的患者，值得临床推广。“,”[Objective] To evaluate the efficacy and toxicity of modified irinotecan plus S‐1 (IRIS) regimen versus classic FOLFIRI in the treatment of distant metastatic colorectal cancer (mCRC) .[Methods] From March 2011 to September 2012 ,a total of 64 mCRC patients were randomly divided into experimental (modi‐fied IRIS ,n = 32) and control (FOLFIRI ,n = 32) groups .The experimental group received modified IRIS while the control group standard FOLFIRI .Adverse reaction and chemotherapeutic efficacy were examined .[Results] No significant inter‐group difference existed in response rate (RR) or disease control rate (DCR) ( P >0 .05) .The major toxicities included myelosuppression ,anorexia ,fatigue ,nausea ,vomiting and diar‐rhea ,etc .There was no grade 4 toxicity .Grade 3 toxicities of neutrocytopenia and vomiting were more com‐mon in control group than experiment group ( P 0 .05) .[Conclusion] The modified IRIS regimen (CPT‐11+S‐1) is both safe and efficacious for patients with metastatic colorectal cancer .Progression‐free survival and overall survival for IRIS is non‐inferior to those for FOLFIRI .Toxic and adverse effects are tolerable and long‐term effects deserve further evaluations .