Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Esophageal Squamous Cell Carcinoma

In brief

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study to assess the efficacy and safety of durvalumab administered concurrently with dCRT in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).

Key facts

Study ID

NCT04550260

Run by

AstraZeneca

People needed

640

Starts

2020-10-19

Expected to finish

2027-06-30

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or older at the time of signing the ICF.
• Histologically or cytologically confirmed esophageal squamous cell carcinoma, and present with locally advanced disease (Stage II-IVA).
• Unresectable or refusing surgery, and has been deemed suitable for definitive chemoradiation therapy.
• Patients with at least an evaluable lesion per RECIST 1.1.
• Mandatory provision of available tumor tissue for PD-L1 expression analysis.
• ECOG PS 0 or 1.
• Adequate organ and marrow function.
• Life expectancy of more than 3 months.

You may not qualify if…

• Histologically or cytologically confirmed small cell esophageal carcinoma, esophageal adenocarcinoma or other mixed carcinoma.
• Prior anti-cancer treatment for ESCC.
• Patient with a great risk of perforation and massive bleeding.
• History of allogeneic organ transplantation.
• Active or prior documented autoimmune or inflammatory disorders.
• Uncontrolled intercurrent illness.
• History of another primary malignancy.
• Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
• Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.

Where it is running

• Research Site — Louisville, Kentucky, United States
• Research Site — Dallas, Texas, United States
• Research Site — Fairfax, Virginia, United States
• Research Site — Morgantown, West Virginia, United States
• Research Site — Brussels, Belgium
• Research Site — Charleroi, Belgium
• Research Site — Liège, Belgium
• Research Site — Namur, Belgium
• Research Site — Barretos, Brazil
• Research Site — Fortaleza, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Rio de Janeiro, Brazil
• Research Site — São José do Rio Preto, Brazil
• Research Site — Vitória, Brazil
• Research Site — Barrie, Ontario, Canada
• Research Site — Greater Sudbury, Ontario, Canada
• Research Site — Anyang, China
• Research Site — Beijing, China
• Research Site — Beijing, China
• Research Site — Bengbu, China
• Research Site — Changsha, China
• Research Site — Changzhi, China
• Research Site — Chengdu, China
• Research Site — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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