Abstract: Objective To evaluate the efficacy and safety of irinotecan(CPT-11)combined capecitabine for patients with advanced or metastatic colorectal cancer.Methods Sixty-two patients with histologically proven advanced colorectal cancer received irinotecan 125mg/m² on day 1, 8, 15 and capecitabine 2500mg/(m²·d)as an intermitent regimen on day 1 to 14.The regimen was repeated every 4 weeks and efficacy and toxicity were evaluated after 2 cycles.The efficacy and safety were assessed on the basis of WHO evaluation standard of Objective therapeutic effect for solid tumor.Results Fifty-nine patients were assessable for responses, including twenty-eight patients received the regimen as the first line chemotherapy and thirty-one patients as the second line chemotherapy.RR was 42.8%, DCR was 71.4%, TTP were 8.6 months and MST were 18.8 months in the first line chemotherapy.RR was 32.3%, DCR was 61.2%, TTP were 7.2 months and MST were 13.2 months in the second line chemotherapy.Dose limiting toxicity was delayed diarrhea and neutropenia.Most of them wereⅠ/Ⅱdegree and tolerable.There was no death during the treatment.Conclusion The combination chemotherapy of irinotecan with capecitabine is an active and tolerable regimen for advanced colorectal cancer.

Key words: Irinotecan, Capecitabine, Aadvanced colorectal cancer