Efficacy and Safety of Quxie Capsule(祛邪胶囊) in Metastatic Colorectal Cancer: A Double-Blind Randomized Placebo Controlled Trial

• 来源期刊: 中国结合医学杂志（英文版）
• 年，卷（期）: 2018,（3）
• 页码范围: 171-177
• 页数: 7页
• 语种: 英文
• DOI: 10.1007/s11655-017-2962-2

摘要

Objective:To verify the efficacy and safety of Quxie Capsule(祛邪胶囊) in patients with metastatic colorectal cancer (mCRC).Methods:The present study was a randomized,double-blind,placebo-controlled trial Sixty patients with mCRC were randomized into two groups at a 1:1 ratio by sealed envelope.The treatment group received conventional therapy combined with Quxie Capsule for 3 months.The control group was treated with conventional therapy combined with placebo for 3 months.Main outcome measures were overall survival (OS) and progression-free survival (PFS).Subgroup analysis was performed according to age,right or left-sided disease,and second-line therapy to determine the differences in PFS and OS between the two groups.Patients were followed up every 3 months until Dec 31st 2016.Results:The median OS was 23 months in the treatment group [95％ confidence interval (CI):15-not calculated] vs.14 months in the control group (95％ CI:11-22,P=0.060).The OS of the treatment group tended to be longer than that of the control group (P＞0.05).In the subgroups of patients ＜65 years old,left-sided colon,and ≥2nd-line therapy,the treatment group showed a significant survival benefit compared with the control group (P--0.006,0.038,0.013,respectively).There were no significant differences between the two groups in PFS (P＞0.05).Safety analysis showed no severe hematological toxicity or liver and renal function injury in the treatment group.Conclusions:Quxie Capsule showed good safety and efficacy,and could prolong the OS of patients with mCRC.(Registration No.ChiCTR-IOR-16009733)