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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

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Abstract

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)

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Authors and Affiliations

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

    Tong Zhang, Yu-fei Yang, Bin He, Jie Hao & Da Zhang

  2. School of Statistics, Renmin University of China, Beijing, 100872, China

    Dan-hui Yi

Authors
  1. Tong Zhang
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  2. Yu-fei Yang
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  3. Bin He
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  4. Dan-hui Yi
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  5. Jie Hao
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  6. Da Zhang
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Corresponding author

Correspondence to Yu-fei Yang.

Additional information

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)

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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

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  • DOI: https://doi.org/10.1007/s11655-017-2962-2

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