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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200166

Enrollment

750

Registered

2020-10-20

Start date

2020-11-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Esophageal Squamous Cell Carcinoma

Interventions

Tiragolumab:600 mg administered by IV infusion on Day 1 of each 21-day cycle Atezolizumab:1200 mg administered by IV infusion on Day 1 of each 21-day cycle

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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 and is not expected to undergo tumor resection during the course of the study - Definitive concurrent chemoradiation treatment according to regional oncology guidelines for esophageal cancer - Representative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens, collected prior to initiation of definitive concurrent chemoradiotherapy - Adequate hematologic and end-organ function

Exclusion criteria

Exclusion criteria: - 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 - 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 - Malignancies other than esophageal cancer within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death - Treatment with any other investigational agent, including epidermal growth factor receptor (EGFR) inhibitors, with therapeutic intent for esophageal cancer prior to randomization

Design outcomes

Primary

Measure	Time frame
Efficacy Observation/Inspection, RECIST v1.1	—

Secondary

Measure	Time frame
Safety,Efficacy,Phamacokinetics Observation/Inspection, RECIST v1.1	—

Countries

ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CHINA, CZECH, FRANCE, GEORGIA, GERMANY, GREECE, HUNGARY, ISRAEL, ITALY, Japan, KENYA, KOREA, MOROCCO, NEW ZEALAND, POLAND, PORTUGAL, RUSSIA FEDERATION, SOUTH AFRICA, SPAIN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED KINGDOM, UNITED STATES

Contacts

Public ContactClinical trials information

Chugai Pharmaceutical Co., Ltd.

clinical-trials@chugai-pharm.co.jp+81-120-189-706

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026