Spots Global Cancer Trial Database for A Study Evaluating the Combination of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or Infusional 5-fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab in Chinese Patients With BRAF V600E Mutant Metastatic Colorectal Cancer.
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Trial Identification
Brief Title: A Study Evaluating the Combination of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or Infusional 5-fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab in Chinese Patients With BRAF V600E Mutant Metastatic Colorectal Cancer.
Official Title: A Multicenter, Randomized, Open-label, 2-arm, Phase II Study With a Safety lead-in Phase Evaluating the Combination of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or Infusional 5-fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab in Chinese Patients With BRAF V600E Mutant Metastatic Colorectal Cancer.
Study ID: NCT05004350
Study Description
Brief Summary: Encorafenib is currently being developed (with or without binimetinib), in combination with cetuximab, for the treatment of adult patients with B-RAF proto-oncogene, serine/threonine kinase V600E mutant (BRAF V600E) metastatic colorectal cancer (mCRC), who have received prior systemic therapy.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Cancer Hospital, Beijing, Beijing, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
Fujian Medical University - Fujian Provincial Cancer Hospital, Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
The First People's Hospital of Foshan, Foshan, Guangdong, China
Cancer Center of Guangzhou Medical University, Guangzhou, Guangdong, China
The Sixth Affiliated Hospital Sun Yat-Sen University, Guangzhou, Guangdong, China
Cancer Hospital Affiliated to Shantou University Medical College, Shantou, Guangdong, China
Peking University Shenzhen Hospital, Shenzhen, Guangdong, China
The Affiliated Hospital of Hebei University, Baoding, Hebei, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Union Hospital Tongji medical college Huazhong University of Science and Technology, Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Xiangya Hospital Central South University, Changsha, Hunan, China
The First People's Hospital of Changzhou, Changzhou, Jiangsu, China
First Affiliated Hospital of Gannan Medical University, Ganzhou, Jiangxi, China
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
The First Hospital of Jilin University, Changchun, Jilin, China
The First Affiliated Hospital of Jinzhou Medical University, Jinzhou, Liaoning, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China
Shaanxi Provincial People's Hospital, Xi'an, Shaanxi, China
Zhongshan Hospital Fudan University, Shanghai, Shanghai, China
Huashan Hospital Fudan University, Shanghai, Shanghai, China
Xinhua Hospital Affilliated to Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China
Shanghai East Hospital, Tongji University, Shanghai, Shanghai, China
The Second People's Hospital of Neijiang, Neijiang, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
The First Affiliated Hospital - Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital - Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Contact Details
Name: Shen Lin, MD
Affiliation: Peking University Cancer Hospital & Institute
Role: PRINCIPAL_INVESTIGATOR
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