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Brief Title: KN046 in Subjects With Advanced Pancreatic Ductal Adenocarcinoma.
Official Title: A Multicenter, Randomized, Double-Blind Phase III Study to Assess the Efficacy and Safety of KN046 Combined With Gemcitabine and Nab-Paclitaxel Versus Placebo Combined With Gemcitabine and Nab-Paclitaxel in First Line Advanced Pancreatic Ductal Adenocarcinoma Subjects (ENREACH-PDAC-01).
Study ID: NCT05149326
Brief Summary: This study is a multicenter, randomized, double-Blind Phase III Study to compare the clinical efficacy and safety of KN046 plus gemcitabine and nab-paclitaxel versus placebo plus gemcitabine and nab-paclitaxel in subjects with advanced pancreatic ductal adenocarcinoma who have not previously received systemic treatment.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Second Hospital Of Anhui medical University, Hefei, Anhui, China
Beijing Cancer Hospital, Beijing, Beijing, China
Beijing Friendship Hospital, Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China
Chinese PLA General Hospital, Beijing, Beijing, China
Peking Union Medical College, Beijing, Beijing, China
Peking University Third Hospital, Beijing, Beijing, China
Chongqing Cancer Hospital, Chongqing, Chongqing, China
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China
The Southwest Hospital of AMU, Chongqing, Chongqing, China
The Third Affiliated Hospital of Army Medical University, Chongqing, Chongqing, China
Fujian Cancer Hospital, Fuzhou, Fujian, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
The First Hospital of Lanzhou University, Lanzhou, Gansu, China
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
The First Affiliated Hospital,Sun Yat-sen University, Guangzhou, Guangdong, China
Affiliated Cancer Hospital of Guangxi Medical University, Nanning, Guangxi, China
The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, China
The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Henan Provincial People's Hospital, Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Renmin Hospital of Wuhan University, Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science And Technology, Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Hunan Provincial People's Hospital, Changsha, Hunan, China
The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
Xiangya Hospital Central South University, Changsha, Hunan, China
The First People's Hospital of Changzhou, Changzhou, Jiangsu, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
Nantong Tumor Hospital, Nantong, Jiangsu, China
The Affiliated Hospital Of XuZhou Medical University, Xuzhou, Jiangsu, China
First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
China-Japan Union Hospital of Jilin University, Changchun, Jilin, China
The First Hospital of Jilin University, Changchun, Jilin, China
Liaoning Cancer Hospital, Shenyang, Liaoning, China
The First Affiliated Hospital of China Medical University, Shenyang, Liaoning, China
Shandong Cancer Hospital, Jinan, Shandong, China
Shandong Provincial Hospital, Jinan, Shandong, China
Affiliated Hospital of Jining Medical University, Jining, Shandong, China
LINYI Cancer Hospital, Linyi, Shandong, China
Linyi City People Hospital, Linyi, Shandong, China
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
Weifang People'S Hospital, Weifang, Shandong, China
Shanghai Changhai Hospital, Shanghai, Shanghai, China
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine , Shanghai University of Traditional Chinese Medicine, Shanghai, Shanghai, China
Zhongshan Hospital Fudan University, Shanghai, Shanghai, China
Shanxi Cancer hospital, Taiyuan, Shanxi, China
Shanxi Provincial People's Hospital, Taiyuan, Shanxi, China
the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, China
Sichuan Cancer Hospital, Chengdu, Sichuan, China
Sichuan Provincial People's Hospital, Chengdu, Sichuan, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
The Second Affiliated Hosipital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Zhejiang Provincial People's hospital, Hangzhou, Zhejiang, China
Jiaxing Second Hospital, Jiaxing, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China