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Brief Title: A Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Participants With Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Carcinoma
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Patients With Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma
Study ID: NCT04540211
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin (PC) compared with atezolizumab matching placebo plus tiragolumab matching placebo plus PC as first-line treatment in participants with unresectable locally advanced, unresectable recurrent, or metastatic esophageal carcinoma (EC). Participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during induction phase: Arm A: Atezolizumab plus Tiragolumab and PC Arm B: Atezolizumab placebo plus Tiragolumab placebo and PC Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab matching placebo plus tiragolumab matching placebo (Arm B).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Anyang Tumor Hosptial, Anyang City, , China
Beijing Luhe Hospital Capital Medical University, Beijing City, , China
Beijing Cancer Hospital, Beijing, , China
the First Hospital of Jilin University, Changchun, , China
Jilin Cancer Hospital, Changchun, , China
Hunan Cancer Hospital, Changsha CITY, , China
Affiliated Hospital of Chengde Medical University, Chengde City, , China
Sichuan Provincial Cancer Hospital, Chengdu, , China
West China Hospital, Sichuan University, Chengdu, , China
Chongqing Sanxia Central Hospital, Chongqing City, , China
The First People's Hospital of Foshan; Local Ethic Committee, Foshan, , China
Fujian Provincial Hospital, Fuzhou City, , China
Fujian Cancer Hospital, Fuzhou, , China
Southern Medical University Nanfang Hospital, Guangdong Province Guangzhou City, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Anhui Province Cancer Hospital, Hefei City, , China
Anhui Provincial Hospital, Hefei, , China
The Second Affiliated Hospital of Anhui Medical University, Hefei, , China
Huai'an First People's Hospital, Huai'an City, , China
The Second People's Hospital of Huai'an, Huai'an City, , China
Affiliated Hopsital of Jining Medical University, Jining, , China
Gansu Province People Hospital, Lanzhou, , China
The First People's Hospital of Lian Yun Gang, Lianyungang, , China
Linyishi Cancer Hospital, Linyi City, , China
The First Affiliated Hospital to Henan University of Science and Technology, Luoyang City, , China
Jiangsu Province Hospital of Chinese Medicine, Nanjing City, , China
Jiangsu Cancer Hospital, Nanjing City, , China
Nan Tong Tumor Hospital, Nantong City, , China
Fudan University Shanghai Cancer Center, Shanghai City, , China
Shanghai Chest Hospital, Shanghai, , China
Zhongshan Hospital Fudan University, Shanghai, , China
Cancer Hospital of Shantou University Medical College, Shantou, , China
Liaoning Provincial Cancer Hospital, Shengyang, , China
The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee, Shenzhen City, , China
Suining Central Hospital, Suining, , China
Tianjin Cancer Hospital, Tianjin, , China
Weifang People's Hospital, Weifang City, , China
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan City, , China
Hubei Cancer Hospital, Wuhan, , China
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ), Wuxi City, , China
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital), Xi'an, , China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an, , China
The First Affiliated Hospital of Xiamen University, Xiamen, , China
Zhongshan Hospital Xiamen University, Xiamen, , China
Xiangyang Central Hospital, Xiangyang, , China
The First Affiliated Hospital of Xinxiang Medical University, Xinxiang City, , China
Xuzhou Central Hospital, Xuzhou, , China
Northern Jangsu People's Hospital, Yangzhou City, , China
Zhejiang Cancer Hospital, Zhejiang, , China
Henan Cancer Hospital, Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, , China
Queen Mary Hospital; Dept. of Clinical Oncology, Hong Kong, , Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc, Shatin, , Hong Kong
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Chang Gung Medical Foundation - Kaohsiung; Oncology, Kaohisung, , Taiwan
National Cheng Kung University Hospital; Oncology, Tainan, , Taiwan
Taipei Veterans General Hospital; Department of Oncology, Taipei City, , Taiwan
National Taiwan University Hospital; Oncology, Zhongzheng Dist., , Taiwan
Chulalongkorn Hospital; Medical Oncology, Bangkok, , Thailand
Rajavithi Hospital; Division of Medical Oncology, Bangkok, , Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc, Bangkok, , Thailand
Siriraj Hospital; Medical Oncology Unit, Bangkok, , Thailand
Songklanagarind Hospital; Department of Oncology, Songkhla, , Thailand
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR