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

Tong Zhang; Yu-fei Yang; Bin He; Dan-hui Yi; Jie Hao; Da Zhang

doi:10.1007/s11655-017-2962-2

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

Updated：2021-08-27

- Efficacy and Safety of Quxie Capsule (祛邪胶囊) in Metastatic Colorectal Cancer: A Double-Blind Randomized Placebo Controlled Trial
- Chinese Journal of Integrative Medicine Vol. 24, Issue 3, Pages: 171-177(2018)
- Affiliations：
  
  1. Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences,Beijing,China
  2. School of Statistics, Renmin University of China,Beijing,China
- Author bio：
- Funds：
  
  Supported by National Natural Science Foundation of China (No. 81373824), Science and Technology Program of Beijing (No. Z131107002213101), Project of the Chinese Academy of Traditional Chinese Medicine (No. ZZ070854)
- DOI：10.1007/s11655-017-2962-2
  CLC：
- Published：2018，
  
  Published Online：24 August 2017，
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Zhang, T., Yang, Yf., He, B. et al. Efficacy and Safety of Quxie Capsule (祛邪胶囊) in Metastatic Colorectal Cancer: A Double-Blind Randomized Placebo Controlled Trial., Chin. J. Integr. Med. 24, 171–177 (2018). https://doi.org/10.1007/s11655-017-2962-2

Tong Zhang, Yu-fei Yang, Bin He, et al. Efficacy and Safety of Quxie Capsule (祛邪胶囊) in Metastatic Colorectal Cancer: A Double-Blind Randomized Placebo Controlled Trial. [J]. Chinese Journal of Integrative Medicine 24(3):171-177(2018)
Zhang, T., Yang, Yf., He, B. et al. Efficacy and Safety of Quxie Capsule (祛邪胶囊) in Metastatic Colorectal Cancer: A Double-Blind Randomized Placebo Controlled Trial., Chin. J. Integr. Med. 24, 171–177 (2018). https://doi.org/10.1007/s11655-017-2962-2 DOI：

Tong Zhang, Yu-fei Yang, Bin He, et al. Efficacy and Safety of Quxie Capsule (祛邪胶囊) in Metastatic Colorectal Cancer: A Double-Blind Randomized Placebo Controlled Trial. [J]. Chinese Journal of Integrative Medicine 24(3):171-177(2018) DOI： 10.1007/s11655-017-2962-2.

摘要

To verify the efficacy and safety of Quxie Capsule (祛邪胶囊) in patients with metastatic colorectal cancer (mCRC). 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. 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. Quxie Capsule showed good safety and efficacy

and could prolong the OS of patients with mCRC. (Registration No. ChiCTR-IOR-16009733)

Abstract

To verify the efficacy and safety of Quxie Capsule (祛邪胶囊) in patients with metastatic colorectal cancer (mCRC). The present study was a randomized

double-blind

right or left-sided disease

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

and could prolong the OS of patients with mCRC. (Registration No. ChiCTR-IOR-16009733)

关键词

Chinese MedicineQuxie Capsulemetastatic colorectal cancerrandomized controlled trial

Keywords

Chinese MedicineQuxie Capsulemetastatic colorectal cancerrandomized controlled trial

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Fujian Provincial Cardiovascular Disease Institute, Provincial Clinical College of Fujian Medical University

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