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

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

机构地区：[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

出　　处：《Chinese Journal of Integrative Medicine》2021年第9期674-679,共6页中国结合医学杂志（英文版）

基　　金：Supported by the Beijing Municipal Commission of Science and Technology (No. D161100005116002)。

摘　　要：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：colorectal cancer conventional chemotherapy complementary therapy Chinese medicine EFFECTIVENESS 

分 类 号：R273[医药卫生—中西医结合]