Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study

Teng-teng HAO; Yun XU; Ning CUI; Qian QU; Bi-yan LIANG; Ju-hua YUAN; Yang ZHAO; Qing-na LI; Fang LU; Yu WU

doi:10.1007/s11655-020-3420-0

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Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study

Original Article | Updated：2021-09-01

- Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study
- Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study
- Chinese Journal of Integrative Medicine 2021年27卷第9期页码：674-679
- Affiliations：
  
  1.Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing(100091), China
  2.Chinese Mdeicine Center for AIDS Prevention and Treatment, China Academy of Chinese Medical Sciences, Beijing(100700), China
  3.Department of Oncology, Beijing Hospital of Integrated Traditional Chinese and Western Medicine, Beijing(100039), China
  4.Institute of Clinical Pharmacology, Xiyuan Hospital, China Academy of Chinese Medicine Sciences, Beijing(100091), China
- Author bio：
  
  Prof. WU Yu, E-mail: wy713@vip.sina.com
- Funds：
  
  the Beijing Municipal Commission of Science and Technology(D161100005116002)
- DOI：10.1007/s11655-020-3420-0
  中图分类号：
- 纸质出版日期：2021-09-01，
  
  网络出版日期：2020-08-19，
  
  录用日期：2020-02-11
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Teng-teng HAO, Yun XU, Ning CUI, 等. Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study[J]. Chinese Journal of Integrative Medicine, 2021,27(9):674-679.

Teng-teng HAO, Yun XU, Ning CUI, et al. Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study[J]. Chinese Journal of Integrative Medicine, 2021,27(9):674-679.
Teng-teng HAO, Yun XU, Ning CUI, 等. Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study[J]. Chinese Journal of Integrative Medicine, 2021,27(9):674-679. DOI： 10.1007/s11655-020-3420-0.

Teng-teng HAO, Yun XU, Ning CUI, et al. Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study[J]. Chinese Journal of Integrative Medicine, 2021,27(9):674-679. DOI： 10.1007/s11655-020-3420-0.

摘要

Abstract

Background:

Colorectal cancer (CRC) is the second most common cause of cancer-related deaths and has the third highest incidence in the world. Almost half of the patients with CRC have metastases at the time of diagnosis. However

the treatment for patients with metastatic CRC that progresses after approved conventional chemotherapy is still controversial. Chinese medicine (CM) has unique characteristics and advantages in treating metastatic CRC.

Objective:

To assess the effectiveness and safety of CM in patients with metastatic CRC after failure of conventional chemotherapy.

Methods:

The study is a multicenter prospective cohort study. A total of 384 patients with documented metastatic CRC after failure of conventional chemotherapy will be included from 9 hospitals at Beijing

Shanghai

Nanjing

and Guizhou

and assigned to three groups according to paitents' wishes: (1) integrated Chinese and Western medicine (ICM) group receiving CM herbal treatment combined with Western medicine (WM) anti-tumor therapy

(2) Chinese medicine (CM) group receiving only CM herbal treatment

and (3) WM group receiving only WM anti-tumor therapy. The primary endpoint is the overall survival (OS). Secondary endpoints include the progression free survival (PFS)

quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaire

tumor control

and CM symptom score.

Discussion:

This prospective study will assess the effectiveness and safety of CM in treating metastatic CRC after conventional chemotherapy failure. Patients in the ICM group will be compared with those in the WM group and CM group. If certified to be effective

national provision of CM treatment in metastatic CRC will probably be advised. (Registration No. NCT02923622)

关键词

Keywords

colorectal cancerconventional chemotherapycomplementary therapyChinese medicineeffectiveness

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