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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental |
| |
| Control arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KN046 | Drug | KN046+Nab-Paclitaxel+Gemcitabine In combine therapy stage, KN046 is 5 milligram per kilogram, every 2 weeks. In maintain stage, KN046 is 5 milligram per kilogram, every 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Time between randomization to date of disease progression or death due to any cause. | up to 2 years |
| Overall response rate (ORR) | Complete Response or Partial Response according to RECIST |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital Of Anhui medical University | Hefei | Anhui | China | |||
| Beijing Cancer Hospital |
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| placebo | Drug | placebo+Nab-Paclitaxel+Gemcitabine In combine therapy stage, placebo is 5 milligram per kilogram, every 2 weeks. In maintain stage, placebo is 5 milligram per kilogram, every 2 weeks. |
|
| up to 2 years |
| Beijing |
| Beijing Municipality |
| China |
| Beijing Friendship Hospital | Beijing | Beijing Municipality | China |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | China |
| Chinese PLA General Hospital | Beijing | Beijing Municipality | China |
| Peking Union Medical College | Beijing | Beijing Municipality | China |
| Peking University Third Hospital | Beijing | Beijing Municipality | China |
| Chongqing Cancer Hospital | Chongqing | Chongqing Municipality | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
| The Southwest Hospital of AMU | Chongqing | Chongqing Municipality | China |
| The Third Affiliated Hospital of Army Medical University | Chongqing | Chongqing Municipality | 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 Municipality | 200433 | China |
| Yueyang Hospital of Integrated Traditional Chinese and Western Medicine , Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai Municipality | China |
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | 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 |