A trial to evaluate whether encorafenib in combination with cetuximab is safe and effective in the Chinese mainland population with BRAFV600E mutant metastatic Colorectal Cancer.

 

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A multicenter, randomized, open-label, 2-arm, Phase II trial 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 BRAFV600E mutant metastatic colorectal cancer.

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Status
Status :
Recruiting
Type of study
Phase II
Min. Age
18
Years old
Max. Age
-
Gender
All

Brief summary

Previous clinical trials have shown that encorafenib in combination with cetuximab is effective to treat patients with metastatic colorectal cancer carrying a specific mutation in the BRAF gene (BRAFV600E).

Encorafenib is a marketed drug (Braftovi®). It is used in combination with cetuximab (Erbitux®) in several countries (European Union, USA, Australia, Japan, Switzerland...) for patients whose disease had worsened following prior systemic therapies.

The purpose of this trial is to prove that this combination would present the same benefits for the Chinese patients.

Therapeutic area :
Oncology
Disease :
BRAFV600E metastatic colorectal cancer 
Study medication :
Encorafenib (BRAFTOVI®) - Cetuximab (ERBITUX®)
Phase : Phase II
Start Date :
02 September 2021
End Date / Planned study Completion Date :
September 2024
Study ID : W00090GE202
CT.gov Number : NCT05004350
Countries :
China

Find out where the clinical trial is conducted

1

Zhongnan Hospital of Wuhan University

No.169 Donghu Road, Wuchang District
Wuhan hubei
430071
China

2

the Sixth Affiliated Hospital

26 Yuancunerheng Road Tianhe district
Guangzhou guangdong
510655
China

3

Zhongshan Hospital Fudan Universityl

No 180 Fenglin Road, Xuhui District
Shanghai
200032
China

4

Xin Hua Hospital Affiliated to Shanghai Jiao Tong

University School of Medicine No. 1665, Kongjiang Road Yangpu District
Shangai
200092
China

5

Xiangya Hospital Central South University

87 Xiangya Road Kaifu District
Changsha hunan
410008
China

6

Union Hospital,Tongji Medical College of Huazhong U.S.T

No. 109, Machang Road Jianghan District
Wuhan hubei
430000
China

7

Tongji Hospital, Tongji Medical College

1095 Jiefang Road, Qiaokou District
Wuhan hubei
430030
China

8

Tianjin Medical University Cancer Institute & Hospital

Huan-Hu-West Road, Hexi District
Tianjin
300060
China

9

The Second People’s Hospital of Neijiang

No. 470, Xinjiang Road Dongxing District,
Neijiang city sichuan
641000
China

10

The Second Affiliated Hospital of Nanchang University

1 Minde Rd. Donghu District
Nanchang jiangxi
330006
China

11

The First hospital of Jilin University

NO. 1 Xinmin Main Street
Changchun jilin
130021
China

12

The First People's Hospital of Foshan

No. 81, Lingnan Avenue North Chancheng District
Foshan city guangdong
528010
China

13

The First People's Hospital of Changzhou

185 Juqian St. Tianning District
Changzhou jiangsu
213004
China

14

The First Hospital of China Medical University

No 155 Nanjing Street Heping district,
Shenyang liaoning
110001
China

15

The First Affiliated Hospital of Xiamen University

55 Zhen Hai Road Siming District
Xiamen fujian
361001
China

16

The First Affiliated Hospital of Zhengzhou University

50 Jianshedonglu, Erqi District
Zhengzhou henan
450000
China

17

The First Affiliated Hospital of Nanchang University

No 1519, Dongyue Av. Nanchang County,
Nanchang jiangxi
330006
China

18

The First Affiliated Hospital

No. 79, Qingchun Road
Hangzhou city zhejiang
310003
China

19

Sir Run Run Shaw Hospital Zhejiang

2 Floor, Science and education building No.3 Qingchun East Road Shangcheng District
Hangzhou zhejang
310016
China

20

Shaanxi Provincial People‘s Hospital

No. 256 West Youyi Road Beilin District
Xian shaanxi
710068
China

21

Shanghai East Hospital, Tongji University

No 18000, Yuntai Road Pudong New District
Shanghai
200123
China

22

Peking University Shenzhen Hospital

1120 Lianhua Road
Shenzhen guangdong
518036
China

23

Peking Union Medical College Hospital

No. 41, Damucang Hutong Xicheng District
Beijing
100730
China

24

Liaoning Cancer Hospital & Institute

44 XiaoheYan Road
Shenyang liaoning
110042
China

25

Jinzhou Medical University (Liaoning Medical University)

No.2, Section 5, Renmin Street, Guta District
Jinzhou city liaoning
121000
China

26

Huashan Hospital Affiliated to Fudan University

12 Wulumuqi Middle Road Jing'an District
Shanghai
200040
China

27

Henan Cancer Hospital

127 Dongming Road
Zhengzhou henan sheng
450008
China

28

Guangzhou Medical University Affiliated Oncology Hospital

No. 78 Hengzhigang, Luhu Road, Yuexiu District
Guangzhou guangdong
510095
China

29

Harbin Medical University Cancer Hospital

Haping Road No.150 Nangang District
Harbin heilongiang
150040
China

30

First Affiliated Hospital of Gannan Medical University

No 128, Jinling Av., Zhanggong District
Ganzhou city jiangxi
341000
China

31

Fujian Medical University -Fujian Provincial Cancer Hospital

420 Fuma Road
Fuzhou city fujian
350014
China

32

Cancer Hospital of Shantou University Medical College

7 Raoping Rd.
Shantou guangdong
515041
China

33

Beijing Cancer Hospital

52 Fucheng Road Haidian District
Beijing
100142
China

34

Affiliated Hospital Of Hebei University

No 648, Dongfeng East Road Lianchi District
Baoding hebei
071000
China

Last update at : 09 September 2024

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