Sign in

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
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

Full criteria on ClinicalTrials.gov

Sites (67)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Anhui Provincial Hospital
Coordinator of this site? Confirm its status
AnhuiChinaUnknown status
Anyang Tumor Hosptial
Coordinator of this site? Confirm its status
AnyangChinaUnknown status
Beijing Luhe Hospital, Capital Medical University
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Jilin Cancer Hospital
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
The First Hospital of Jilin University
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
Hunan Cancer Hospital
Coordinator of this site? Confirm its status
ChangshaChinaUnknown status
Affiliated Hospital of Chengde Medical University
Coordinator of this site? Confirm its status
ChengdeChinaUnknown status
Sichuan Provincial Cancer Hospital
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
West China Hospital,Sichuan University
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
Chongqing Sanxia Central Hospital
Coordinator of this site? Confirm its status
ChongqingChinaUnknown status
The First People's Hospital of Foshan
Coordinator of this site? Confirm its status
FoshanChinaUnknown status
Fujian Provincial Hospital
Coordinator of this site? Confirm its status
FuzhouChinaUnknown status
Fujian Cancer Hospital
Coordinator of this site? Confirm its status
FuzhouChinaUnknown status
Southern Medical University Nanfang Hospital
Coordinator of this site? Confirm its status
Guangdong Province Guangzhou CityChinaUnknown status
Zhejiang Cancer Hospital
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
Coordinator of this site? Confirm its status
HarbinChinaUnknown status
Anhui Province cancer hospital
Coordinator of this site? Confirm its status
HefeiChinaUnknown status
The Second Affiliated Hospital Of Anhui Medical University
Coordinator of this site? Confirm its status
HefeiChinaUnknown status
The Second People's Hospital of Huai'an
Coordinator of this site? Confirm its status
Huai'anChinaUnknown status
Huai'an First People's Hospital
Coordinator of this site? Confirm its status
Huai'anChinaUnknown status
Affiliated Hopsital of Jining Medical University
Coordinator of this site? Confirm its status
JiningChinaUnknown status
Gansu Province People Hospital
Coordinator of this site? Confirm its status
LanzhouChinaUnknown status
The First People's Hospital of Lian Yun Gang
Coordinator of this site? Confirm its status
LianyungangChinaUnknown status
Linyishi Cancer Hospital
Coordinator of this site? Confirm its status
LinyiChinaUnknown status
The First Affiliated Hospital to Henan University of Science and Technology
Coordinator of this site? Confirm its status
LuoyangChinaUnknown status
Jiangsu Province Hospital of Chinese Medicine
Coordinator of this site? Confirm its status
NanjingChinaUnknown status
Jiangsu Cancer Hospital
Coordinator of this site? Confirm its status
NanjingChinaUnknown status
Nan Tong Tumor Hospital
Coordinator of this site? Confirm its status
NantongChinaUnknown status
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Zhongshan Hospital,Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Shanghai Chest Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Cancer Hospital of Shantou University Medical College
Coordinator of this site? Confirm its status
ShantouChinaUnknown status
Liaoning Provincial Cancer Hospital
Coordinator of this site? Confirm its status
ShengyangChinaUnknown status
Suining Central Hospital
Coordinator of this site? Confirm its status
SuiningChinaUnknown status
Tianjin Cancer Hospital
Coordinator of this site? Confirm its status
TianjinChinaUnknown status
Weifang People's Hospital
Coordinator of this site? Confirm its status
WeifangChinaUnknown status
Hubei Cancer Hospital
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital )
Coordinator of this site? Confirm its status
WuxiChinaUnknown status
The First Affiliated hospital of Xiamen University
Coordinator of this site? Confirm its status
XiamenChinaUnknown status
Zhongshan Hospital Xiamen University
Coordinator of this site? Confirm its status
XiamenChinaUnknown status
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
Coordinator of this site? Confirm its status
Xi'anChinaUnknown status
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Coordinator of this site? Confirm its status
Xi'anChinaUnknown status
Xiangyang Central Hospital
Coordinator of this site? Confirm its status
XiangyangChinaUnknown status
The First Affiliated Hospital of Xinxiang Medical University
Coordinator of this site? Confirm its status
XinxiangChinaUnknown status
Xuzhou Central Hospital
Coordinator of this site? Confirm its status
XuzhouChinaUnknown status
Northern Jangsu People's Hospital
Coordinator of this site? Confirm its status
YangzhouChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status
Henan Cancer Hospital
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status
Queen Mary Hospital
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaUnknown status
Prince of Wales Hosp
Coordinator of this site? Confirm its status
ShatinHong Kong SAR ChinaUnknown status
Kyungpook National University Chilgok Hospital
Coordinator of this site? Confirm its status
DaeguSouth KoreaUnknown status
National Cancer Center
Coordinator of this site? Confirm its status
Goyang-siSouth KoreaUnknown status
Seoul National University Bundang Hospital
Coordinator of this site? Confirm its status
Seongnam-siSouth KoreaUnknown status
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Korea University Guro Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Siriraj Hospital
Coordinator of this site? Confirm its status
BangkokThailandUnknown status
Ramathibodi Hospital
Coordinator of this site? Confirm its status
BangkokThailandUnknown status
Chulalongkorn Hospital
Coordinator of this site? Confirm its status
BangkokThailandUnknown status
Rajavithi Hospital
Coordinator of this site? Confirm its status
BangkokThailandUnknown status
Songklanagarind Hospital
Coordinator of this site? Confirm its status
SongkhlaThailandUnknown status
Chang Gung Medical Foundation - Kaohsiung
Coordinator of this site? Confirm its status
KaohisungTaiwanUnknown status
National Cheng Kung University Hospital
Coordinator of this site? Confirm its status
TainanTaiwanUnknown status
Taipei Veterans General Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
National Taiwan University Hospital
Coordinator of this site? Confirm its status
Zhongzheng Dist.TaiwanUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.