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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
Sponsor: Hoffmann-La Roche
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).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
461
Start Date
2020-10-30
Completion Date
2025-08-28
Last Updated
2026-08-27
Healthy Volunteers
No
Conditions
Interventions
Atezolizumab
Atezolizumab at a fixed dose of 1200 milligrams (mg) administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Tiragolumab
Tiragolumab at a fixed dose of 600 mg administered by IV infusion every Q3W on Day 1 of each 21-day cycle.
Paclitaxel
Paclitaxel 175 mg/m\^2 administered by IV infusion on Day 1 of each 21-day cycle for 6 cycles.
Cisplatin
Cisplatin 60-80 mg/m\^2 administered by IV infusion on Day 1 of each 21-day cycle for 6 cycles.
Atezolizumab Matching Placebo
Atezolizumab matching placebo administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Tiragolumab Matching Placebo
Tiragolumab matching placebo administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Locations (67)
Anhui Provincial Hospital
Anhui, China
Anyang Tumor Hosptial
Anyang, China
Beijing Luhe Hospital Capital Medical University
Beijing, China
the First Hospital of Jilin University
Changchun, China
Jilin Cancer Hospital
Changchun, China
Hunan Cancer Hospital
Changsha, China
Affiliated Hospital of Chengde Medical University
Chengde, China
Sichuan Provincial Cancer Hospital
Chengdu, China
West China Hospital, Sichuan University
Chengdu, China
Chongqing Sanxia Central Hospital
Chongqing, China
The First People's Hospital of Foshan
Foshan, China
Fujian Cancer Hospital
Fuzhou, China
Fujian Provincial Hospital
Fuzhou, China
Southern Medical University Nanfang Hospital
Guangdong Province Guangzhou City, China
Zhejiang Cancer Hospital
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Anhui Province Cancer Hospital
Hefei, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, China
Huai'an First People's Hospital
Huai'an, China
The Second People's Hospital of Huai'an
Huai'an, 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, China
The First Affiliated Hospital to Henan University of Science and Technology
Luoyang, China
Jiangsu Province Hospital of Chinese Medicine
Nanjing, China
Jiangsu Cancer Hospital
Nanjing, China
Nan Tong Tumor Hospital
Nantong, China
Shanghai Chest Hospital
Shanghai, China
Zhongshan Hospital Fudan University
Shanghai, China
Fudan University Shanghai Cancer Center
Shanghai, China
Cancer Hospital of Shantou University Medical College
Shantou, China
Liaoning Provincial Cancer Hospital
Shengyang, China
Suining Central Hospital
Suining, China
Tianjin Cancer Hospital
Tianjin, China
Weifang People's Hospital
Weifang, China
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Hubei Cancer Hospital
Wuhan, China
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital )
Wuxi, 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, China
Xuzhou Central Hospital
Xuzhou, China
Northern Jangsu People's Hospital
Yangzhou, China
Henan Cancer Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales Hosp
Shatin, Hong Kong
Kyungpook National University Chilgok Hospital
Daegu, South Korea
National Cancer Center
Goyang-si, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Chang Gung Medical Foundation - Kaohsiung
Kaohisung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
National Taiwan University Hospital
Zhongzheng Dist., Taiwan
Chulalongkorn Hospital
Bangkok, Thailand
Rajavithi Hospital
Bangkok, Thailand
Ramathibodi Hospital
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand
Songklanagarind Hospital
Songkhla, Thailand