For Healthcare Professionals

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

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About the study

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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


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

EXCLUSION CRITERIA

Exclusion Criteria:


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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Esophageal Squamous Cell Carcinoma

Age (in years)

18 - 130

Phase

Phase 3

Participants needed

640

Est. Completion Date

Nov 30, 2026

Treatment type

Interventional


Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT04550260

Study number

D910SC00001

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