Fact CheckerSign in

NCT04543617CompletedPhase 3

A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab With or Without Tiragolumab (Anti-TIGIT Antibody) in Patients With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy

Source: ClinicalTrials.gov · Last updated 14 Sept 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
760 (actual)
First submitted
3 Sept 2020
Start date
28 Sept 2020
Primary completion date
22 Jul 2026
Lead sponsor
Hoffmann-La Roche
NCT number
NCT04543617
EudraCT number
2020-001178-31

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 760
  • From 28 Sept 2020 to the primary completion date, 22 Jul 2026
  • 166 sites in 28 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

  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-TIGIT therapeutic antibodies
  • Any unresolved toxicity of National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 from the prior chemoradiation therapy with the exception of irreversible and manageable hearing loss
  • Prior allogeneic stem cell or solid organ transplantation
  • Malignancies other than esophageal cancer within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death

Other illness

  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis

Lab values

  • Treatment with any other investigational agent, including epidermal growth factor receptor (EGFR) inhibitors, with therapeutic intent for esophageal cancer prior to randomization.

Who the study is looking for

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus
  • Unresectable disease ineligible for curative surgery based on the documented opinion of the qualified medical, surgical or radiation oncologist prior to dCRT and is not expected to undergo tumor resection during the course of the study
  • dCRT treatment according to regional oncology guidelines for esophageal cancer
  • Representative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens collected prior to initiation of dCRT
  • Adequate hematologic and end-organ function prior to randomization
  • Women of childbearing potential must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period, for 5 months after the final dose of atezolizumab/placebo, and for 90 days after the final dose of tiragolumab/placebo, whichever is later
  • Men must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab/placebo.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (166)

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

SiteCityCountrySite status
Instituto de Investigaciones Metabolicas (IDIM)
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Fundacion Favaloro
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Centro Oncologico Riojano Integral (Cori)
Coordinator of this site? Confirm its status
La RiojaArgentinaUnknown status
Tiroler Landeskrankenanstalten Ges.M.B.H.
Coordinator of this site? Confirm its status
InnsbruckAustriaUnknown status
Klinikum Klagenfurt am Worthersee
Coordinator of this site? Confirm its status
KlagenfurtAustriaUnknown status
Ordensklinikum Linz Barmherzige Schwestern
Coordinator of this site? Confirm its status
LinzAustriaUnknown status
AKH - Medizinische Universitat Wien
Coordinator of this site? Confirm its status
ViennaAustriaUnknown status
Austin Health
Coordinator of this site? Confirm its status
HeidelbergAustraliaUnknown status
St John of God Hospital
Coordinator of this site? Confirm its status
SubiacoAustraliaUnknown status
Princess Alexandra Hospital
Coordinator of this site? Confirm its status
WoolloongabbaAustraliaUnknown status
UZ Antwerpen
Coordinator of this site? Confirm its status
EdegemBelgiumUnknown status
UZ Leuven Gasthuisberg
Coordinator of this site? Confirm its status
LeuvenBelgiumUnknown status
CHU de Liège (Sart Tilman)
Coordinator of this site? Confirm its status
LiègeBelgiumUnknown status
Inselspital Bern, Insel-Gruppe AG
Coordinator of this site? Confirm its status
BernSwitzerlandUnknown status
Universitätsspital Zürich
Coordinator of this site? Confirm its status
ZurichSwitzerlandUnknown status
Anyang Tumor Hosptial
Coordinator of this site? Confirm its status
AnyangChinaUnknown status
Cancer Hospital, Chinese Academy of Medical Sciences
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Affiliated Hospital of Bengbu Medical College
Coordinator of this site? Confirm its status
BengbuChinaUnknown status
Hunan Cancer Hospital
Coordinator of this site? Confirm its status
ChangshaChinaUnknown status
Heping Hospital Affiliated to Changzhi Medical College
Coordinator of this site? Confirm its status
ChangzhiChinaUnknown status
Changzhou Cancer Hospital
Coordinator of this site? Confirm its status
ChangzhouChinaUnknown 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 Cancer Hospital
Coordinator of this site? Confirm its status
ChongqingChinaUnknown status
Chongqing Sanxia Central Hospital
Coordinator of this site? Confirm its status
ChongqingChinaUnknown status
Fujian Cancer Hospital
Coordinator of this site? Confirm its status
FuzhouChinaUnknown status
Nanfang Hospital, Southern Medical University
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Sun Yet-Sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Zhejiang Cancer Hospital
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Jieyang People's Hospital
Coordinator of this site? Confirm its status
JieyangChinaUnknown status
Shandong Cancer Hospital
Coordinator of this site? Confirm its status
JinanChinaUnknown status
Affiliated Hospital of Jining Medical University
Coordinator of this site? Confirm its status
JiningChinaUnknown status
The First People's Hospital of Lian Yun Gang
Coordinator of this site? Confirm its status
LianyungangChinaUnknown status
Lishui Central Hospital
Coordinator of this site? Confirm its status
LishuiChinaUnknown status
The First Affiliated Hospital to Henan University of Science and Technology
Coordinator of this site? Confirm its status
LuoyangChinaUnknown status
Affiliated Drum Tower Hospital of Nanjing University Medical School
Coordinator of this site? Confirm its status
NanjingChinaUnknown status
Fudan University Shanghai Cancer Center
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 Cancer Hospital & Institute
Coordinator of this site? Confirm its status
ShenyangChinaUnknown status
Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen Center
Coordinator of this site? Confirm its status
ShenzhenChinaUnknown status
Hebei Medical University Fourth Hospital
Coordinator of this site? Confirm its status
ShijiazhuangChinaUnknown status
Tianjin Cancer Hospital
Coordinator of this site? Confirm its status
TianjinChinaUnknown 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
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 First Affiliated Hospital of Xinxiang Medical University
Coordinator of this site? Confirm its status
XinxiangChinaUnknown status
The Affiliated Hospital of Xuzhou Medical College
Coordinator of this site? Confirm its status
XuzhouChinaUnknown status
Subei People's Hospital of Jiangsu province
Coordinator of this site? Confirm its status
YangzhouChinaUnknown status
Universitätsklinikum Essen Klinik f.Strahlentherapie
Coordinator of this site? Confirm its status
EssenGermanyUnknown status
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie
Coordinator of this site? Confirm its status
EssenGermanyUnknown status
Klinik für Gastroenterologie und Gastrointestinale Onkologie der UMG
Coordinator of this site? Confirm its status
GöttingenGermanyUnknown status
Universitaetsklinikum Leipzig
Coordinator of this site? Confirm its status
LeipzigGermanyUnknown status
Med. Fak. d. Otto-von-Guericke-Universität
Coordinator of this site? Confirm its status
MagdeburgGermanyUnknown status
Klinikum der Philipps-Universität Marburg
Coordinator of this site? Confirm its status
MarburgGermanyUnknown status
Universitätsklinikum Klinik u.Poliklinik f.Strahlentherapie
Coordinator of this site? Confirm its status
RegensburgGermanyUnknown status
Complejo Hospitalario Universitario A Coruña (CHUAC)
Coordinator of this site? Confirm its status
A CoruñaSpainUnknown status
Hospital Clinic i Provincial
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Hospital Universitario Reina Sofia
Coordinator of this site? Confirm its status
CórdobaSpainUnknown status
Fundación Jiménez Díaz
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Hospital Regional Universitario Carlos Haya
Coordinator of this site? Confirm its status
MálagaSpainUnknown status
Hospital Univ. Central de Asturias
Coordinator of this site? Confirm its status
OviedoSpainUnknown status
Hospital La Fe
Coordinator of this site? Confirm its status
ValenciaSpainUnknown status
Hospital Clinico Universitario de Valencia
Coordinator of this site? Confirm its status
ValenciaSpainUnknown status
CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie
Coordinator of this site? Confirm its status
BrestFranceUnknown status
CHU Dijon Bourgogne Hôpital François Mitterand
Coordinator of this site? Confirm its status
DijonFranceUnknown status
Hopital Claude Huriez
Coordinator of this site? Confirm its status
LilleFranceUnknown status
Centre Leon Berard
Coordinator of this site? Confirm its status
LyonFranceUnknown status
Hopital Timone Adultes
Coordinator of this site? Confirm its status
MarseilleFranceUnknown status
Centre Antoine Lacassagne
Coordinator of this site? Confirm its status
NiceFranceUnknown status
European Hospital Georges Pompidou (HEGP)
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Hôpital du Haut Leveque
Coordinator of this site? Confirm its status
PessacFranceUnknown status
CHU la Miletrie
Coordinator of this site? Confirm its status
PoitiersFranceUnknown status
Hopital Rangueil
Coordinator of this site? Confirm its status
ToulouseFranceUnknown status
Royal Bournemouth Hospital
Coordinator of this site? Confirm its status
BournemouthUnited KingdomUnknown status
Addenbrookes Hospital
Coordinator of this site? Confirm its status
CambridgeUnited KingdomUnknown status
Royal Marsden Hospital - Fulham
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Ninewells Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Clatterbridge Cancer Centre
Coordinator of this site? Confirm its status
Metropolitan Borough of WirralUnited KingdomUnknown status
Royal Marsden Hospital (Sutton)
Coordinator of this site? Confirm its status
SuttonUnited KingdomUnknown status
Evgenidio Hospital "Agia Trias"
Coordinator of this site? Confirm its status
AthensGreeceUnknown status
Univ General Hosp Heraklion
Coordinator of this site? Confirm its status
HeraklionGreeceUnknown status
Euromedical General Clinic of Thessaloniki
Coordinator of this site? Confirm its status
ThessalonikiGreeceUnknown status
Pécsi Tudományegyetem
Coordinator of this site? Confirm its status
PécsHungaryUnknown status
Szegedi Tudomanyegyetem
Coordinator of this site? Confirm its status
SzegedHungaryUnknown status
Hadassah Ein Karem Hospital
Coordinator of this site? Confirm its status
JerusalemIsraelUnknown status
Rambam Health Corporation
Coordinator of this site? Confirm its status
RambamIsraelUnknown status
Tel Aviv Sourasky Medical Ctr
Coordinator of this site? Confirm its status
Tel AvivIsraelUnknown status
Ospedale Degli Infermi - Faenza
Coordinator of this site? Confirm its status
FaenzaItalyUnknown status
Universita degli Studi della Campania Luigi Vanvitelli
Coordinator of this site? Confirm its status
NaplesItalyUnknown status
Istituto Oncologico Veneto - IRCCS
Coordinator of this site? Confirm its status
PadovaItalyUnknown status
Asu Fc S. M. Della Misericordia
Coordinator of this site? Confirm its status
UdineItalyUnknown status
Aichi Cancer Center Hospital
Coordinator of this site? Confirm its status
AichiJapanUnknown status
National Cancer Center Hospital East
Coordinator of this site? Confirm its status
ChibaJapanUnknown status
Hiroshima University Hospital
Coordinator of this site? Confirm its status
HiroshimaJapanUnknown status
Kobe University Hospital
Coordinator of this site? Confirm its status
HyōgoJapanUnknown status
Kanagawa Cancer Center
Coordinator of this site? Confirm its status
KanagawaJapanUnknown status
Yokohama City University Medical Center
Coordinator of this site? Confirm its status
KanagawaJapanUnknown status
Tohoku University Hospital
Coordinator of this site? Confirm its status
MiyagiJapanUnknown status
Niigata Cancer Center Hospital
Coordinator of this site? Confirm its status
NiigataJapanUnknown status
The University of Osaka Hospital
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Osaka International Cancer Institute
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Saitama Medical University International Medical Center
Coordinator of this site? Confirm its status
SaitamaJapanUnknown status
Saitama Cancer Center
Coordinator of this site? Confirm its status
SaitamaJapanUnknown status
Shizuoka Cancer Center
Coordinator of this site? Confirm its status
ShizuokaJapanUnknown status
The Cancer Institute Hospital of JFCR
Coordinator of this site? Confirm its status
TokyoJapanUnknown status
Keio University Hospital
Coordinator of this site? Confirm its status
TokyoJapanUnknown status
International Cancer Institute (ICI)
Coordinator of this site? Confirm its status
EldoretKenyaUnknown status
The Aga Khan University-Kenya.
Coordinator of this site? Confirm its status
NairobiKenyaUnknown status
Kyungpook National University Chilgok Hospital
Coordinator of this site? Confirm its status
DaeguSouth KoreaUnknown status
Ajou University Medical Center
Coordinator of this site? Confirm its status
Gyeonggi-doSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
Coordinator of this site? Confirm its status
Jeollanam-doSouth 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
Centre Hospitalier Universitaire Hassan II
Coordinator of this site? Confirm its status
FesMoroccoUnknown status
Centre Hospitalier Universitaire Mohamed VI
Coordinator of this site? Confirm its status
MarrakeshMoroccoUnknown status
Institut National D'oncologie Sidi Med Benabdellah
Coordinator of this site? Confirm its status
RabatMoroccoUnknown status
Tauranga Hospital, Clinical Trials Unit
Coordinator of this site? Confirm its status
TaurangaNew ZealandUnknown status
Centrum Onkologii
Coordinator of this site? Confirm its status
BydgoszczPolandUnknown status
Centrum Onkologii Ziemi Lubelskiej im. w. Jana z Dukli
Coordinator of this site? Confirm its status
LublinPolandUnknown status
Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii
Coordinator of this site? Confirm its status
OlsztynPolandUnknown status
Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie
Coordinator of this site? Confirm its status
PóźnaPolandUnknown status
NIO im Marii Sklodowskiej-Curie
Coordinator of this site? Confirm its status
WarsawPolandUnknown status
Dolno?l?skie Centrum Onkologii
Coordinator of this site? Confirm its status
Wroc?awPolandUnknown status
HUC
Coordinator of this site? Confirm its status
CoimbraPortugalUnknown status
IPO do Porto
Coordinator of this site? Confirm its status
PortoPortugalUnknown status
Centro Hospitalar do Porto - Hospital de Santo António
Coordinator of this site? Confirm its status
PortoPortugalUnknown status
City Oncological Hospital
Coordinator of this site? Confirm its status
IzhevskRussiaUnknown status
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
Coordinator of this site? Confirm its status
Kazan'RussiaUnknown status
Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky
Coordinator of this site? Confirm its status
KrasnoyarskRussiaUnknown status
Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status
Limited Liability Company "RC Medical"
Coordinator of this site? Confirm its status
NovosibirskRussiaUnknown status
Scientific Research Institute n.a. N.N. Petrov
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
Regional Oncology Dispensary
Coordinator of this site? Confirm its status
TomskRussiaUnknown status
Ramathibodi Hospital
Coordinator of this site? Confirm its status
BangkokThailandUnknown status
Vajira Hospital
Coordinator of this site? Confirm its status
BangkokThailandUnknown status
Chulalongkorn 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;Oncology
Coordinator of this site? Confirm its status
KaohisungTaiwanUnknown status
China Medical University Hospital
Coordinator of this site? Confirm its status
TaichungTaiwanUnknown status
National Cheng Kung University Hospital
Coordinator of this site? Confirm its status
TainanTaiwanUnknown status
Chi-Mei Medical Centre
Coordinator of this site? Confirm its status
TainanTaiwanUnknown status
National Taiwan University Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
Taipei Veterans General Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
Municipal Noncommercial Institution Regional Center of Oncology
Coordinator of this site? Confirm its status
KharkivUkraineUnknown status
RCI Sumy Regional Clinical Oncological Dispensary
Coordinator of this site? Confirm its status
SumyUkraineUnknown status
Vinnytsya Regional Clinical Oncology Dispensary
Coordinator of this site? Confirm its status
VinnytsiaUkraineUnknown status
Zhytomyr Regional Oncology Center
Coordinator of this site? Confirm its status
ZhytomyrUkraineUnknown status
Florida Cancer Specialists - Fort Myers (Broadway)
Coordinator of this site? Confirm its status
Fort MyersUnited StatesUnknown status
Cancer Center of Kansas
Coordinator of this site? Confirm its status
WichitaUnited StatesUnknown status
Great Lakes Cancer Center
Coordinator of this site? Confirm its status
WilliamsvilleUnited StatesUnknown status
Limpopo Cancer Research Institute
Coordinator of this site? Confirm its status
PolokwaneSouth AfricaUnknown status
Cancercare
Coordinator of this site? Confirm its status
Port ElizabethSouth AfricaUnknown status
Eugene Marais Hospital
Coordinator of this site? Confirm its status
PretoriaSouth AfricaUnknown status
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital
Coordinator of this site? Confirm its status
AdanaTurkey (Türkiye)Unknown status
Ankara City Hospital
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Unknown status
Ankara University Faculty of Medicine Cebeci Hospital
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Unknown status
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
Coordinator of this site? Confirm its status
ErzurumTurkey (Türkiye)Unknown status
Goztepe Prof.Dr. Suleyman Yalcin City Hospital
Coordinator of this site? Confirm its status
KadiköyTurkey (Türkiye)Unknown status
Inonu University Faculty of Medicine Turgut Ozal Medical Center
Coordinator of this site? Confirm its status
MalatyaTurkey (Türkiye)Unknown status
Van Yuzuncu Yil University Hospital
Coordinator of this site? Confirm its status
VanTurkey (Türkiye)Unknown status

Related publications

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