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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.
Sponsor: Pierre Fabre Medicament
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.
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
107
Start Date
2021-09-14
Completion Date
2024-12-07
Last Updated
2026-04-30
Healthy Volunteers
No
Conditions
Interventions
Encorafenib
oral hard capsule
Cetuximab
intravenous infusion
FOLFIRI
Combination of: irinotecan ( also known as: Camptosar, Camptothecin-11 and CPT-11) intravenous infusion, folinic acid (also known as: 5-formyl tetrahydrofolic acid and leucovorin) intravenous infusion, and 5-FU (also known as; fluorouracil) intravenous bolus/intravenous infusion
Locations (34)
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 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 Municipality, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affilliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai East Hospital, Tongji University
Shanghai, Shanghai Municipality, China
The Second People's Hospital of Neijiang
Neijiang, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 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