NCT04540211CompletedPhase 3
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
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
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 461 (actual)
- First submitted
- 3 Sept 2020
- Start date
- 30 Oct 2020
- Primary completion date
- 13 Feb 2023
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04540211
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 461
- From 30 Oct 2020 to the primary completion date, 13 Feb 2023
- 67 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Palliative radiation treatment for EC within 4 weeks prior to initiation of study treatment
- Malignancies other than EC within 2 years prior to screening with a negligible risk of metastasis or death adequately treated with expected curative outcome
- Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with any investigational therapy prior to initiation of study treatment
- Prior allogeneic stem cell or solid organ transplantation
- Concurrent participation in another therapeutic clinical trial
Other illness
- Active or history of autoimmune disease or immune deficiency or leptomeningeal disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
- Positive test result for human immunodeficiency virus (HIV)
- Active hepatitis B or hepatitis C
Other
- Evidence of complete esophageal obstruction not amenable to treatment
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- Uncontrolled tumor-related pain, uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Poor peripheral venous access
Who the study is looking for
- Histologically confirmed EC
- Unresectable locally advanced, unresectable recurrent, or metastatic disease
- Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate hematologic and end-organ function
- Female participants must be willing to avoid pregnancy and refrain from donating eggs during the treatment period and for 90 days after the final dose
- Male participants with partners of childbearing potential must commit to the use of two methods of contraception and must not donate sperm for the study duration and 90 days after the final dose
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (67)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Anhui | China | Unknown status |
| Anyang Tumor Hosptial Coordinator of this site? Confirm its status | Anyang | China | Unknown status |
| Beijing Luhe Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Jilin Cancer Hospital Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Affiliated Hospital of Chengde Medical University Coordinator of this site? Confirm its status | Chengde | China | Unknown status |
| Sichuan Provincial Cancer Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chongqing Sanxia Central Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| The First People's Hospital of Foshan Coordinator of this site? Confirm its status | Foshan | China | Unknown status |
| Fujian Provincial Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Southern Medical University Nanfang Hospital Coordinator of this site? Confirm its status | Guangdong Province Guangzhou City | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Anhui Province cancer hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| The Second Affiliated Hospital Of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| The Second People's Hospital of Huai'an Coordinator of this site? Confirm its status | Huai'an | China | Unknown status |
| Huai'an First People's Hospital Coordinator of this site? Confirm its status | Huai'an | China | Unknown status |
| Affiliated Hopsital of Jining Medical University Coordinator of this site? Confirm its status | Jining | China | Unknown status |
| Gansu Province People Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| The First People's Hospital of Lian Yun Gang Coordinator of this site? Confirm its status | Lianyungang | China | Unknown status |
| Linyishi Cancer Hospital Coordinator of this site? Confirm its status | Linyi | China | Unknown status |
| The First Affiliated Hospital to Henan University of Science and Technology Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| Jiangsu Province Hospital of Chinese Medicine Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Jiangsu Cancer Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Nan Tong Tumor Hospital Coordinator of this site? Confirm its status | Nantong | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Cancer Hospital of Shantou University Medical College Coordinator of this site? Confirm its status | Shantou | China | Unknown status |
| Liaoning Provincial Cancer Hospital Coordinator of this site? Confirm its status | Shengyang | China | Unknown status |
| Suining Central Hospital Coordinator of this site? Confirm its status | Suining | China | Unknown status |
| Tianjin Cancer Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Weifang People's Hospital Coordinator of this site? Confirm its status | Weifang | China | Unknown status |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| Zhongshan Hospital Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital) Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Xiangyang Central Hospital Coordinator of this site? Confirm its status | Xiangyang | China | Unknown status |
| The First Affiliated Hospital of Xinxiang Medical University Coordinator of this site? Confirm its status | Xinxiang | China | Unknown status |
| Xuzhou Central Hospital Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| Northern Jangsu People's Hospital Coordinator of this site? Confirm its status | Yangzhou | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Prince of Wales Hosp Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Unknown status |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Ramathibodi Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Chulalongkorn Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Rajavithi Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Songklanagarind Hospital Coordinator of this site? Confirm its status | Songkhla | Thailand | Unknown status |
| Chang Gung Medical Foundation - Kaohsiung Coordinator of this site? Confirm its status | Kaohisung | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Zhongzheng Dist. | Taiwan | Unknown status |
Related publications
- First-line tiragolumab plus atezolizumab and chemotherapy in patients with previously untreated, locally advanced unresectable or metastatic oesophageal cancer (MORPHEUS-EC): a randomised, open-label, phase 1b/2 trial.Lancet Oncol · 2026 · PMID 41449151
- Tiragolumab plus atezolizumab and chemotherapy as first-line treatment for patients with unresectable oesophageal squamous cell carcinoma (SKYSCRAPER-08): a randomised, double-blind, placebo-controlled, phase 3 trial.Lancet Oncol · 2026 · PMID 41449142
This page is information, not medical advice. Discuss any trial with your doctor.