Objective:To verify the efficacy of Quxie Capsule in patients with metastatic colorectal cancer(mCRC).Methods:It was a block randomized,double-blind,placebo-controlled trial.Sixty patients with mCRC were randomized into 2 groups at a 1∶1 ratio.The patients in the treatment group received conventional therapy including chemotherapy,radiotherapy,targeted therapy and supportive care,and Chinese herbal medicine combined with Quxie Capsule(each capsule of 0.4 g was orally administered at 50 mg/kg,twice daily,day 1-20,in a 30-day course)for 3 months.The patients in the control group received conventional therapy and Chinese herbal medicine combined with placebo for 3 months.Main outcome measures were overall survival(OS)and progression-free survival(PFS).Subgroup analysis was performed according to therapy lines,right or left-sided colon,targeted therapy and RAS gene status to determine the differences in PFS and OS between the two groups.Patients were followed up every 3 months until December 31st,2018.Results:Median follow-up time was 19.4 months.The median OS was 23.9 months in the treatment group[95％confidence interval(CI)15.9-28.5]vs.14.3 months in the control group(95％Cl 11.3-21.4,P＜0.05).Hazard ratio(95％CI)was 0.55(0.31-0.95,P=0.040).There were no significant differences between the two groups in PFS(P＞0.05).In the subgroups of≥second-line therapy,non-targeted therapy,RAS gene wild type and left-sided colon,the treatment group showed a significant survival benefit compared with the control group(P＜0.05 or P＜0.01),respectively.Conclusion:Quxie Capsule can reduce the risk of death and prolong the OS of patients with mCRC.

ZHANG Tong;XU Yun;SUN Ling-yun;HE Bin;HAO Jie;ZHANG Da;YANG Yu-fei

Department of Oncology,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China

中国结合医学杂志（英文版）

[1]ZHANG Tong;XU Yun;SUN Ling-yun;HE Bin;HAO Jie;ZHANG Da;YANG Yu-fei-.Efficacy of Quxie Capsule in Metastatic Colorectal Cancer:Long-Term Survival Update of A Double-Blind,Randomized,Placebo Controlled Trial)[J].中国结合医学杂志（英文版）,2022(11):971-974

Quxie

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