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

• Status: Recruiting
• Trial end date: 2026-10-30
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Capecitabine; Cisplatin; Durvalumab; Fluorouracil

Criteria

Inclusion Criteria:

• 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 and has been deemed suitable for definitive chemoradiation therapy.

• Patients with at least 1 lesion that qualifies as a RECIST 1.1 Target Lesion at baseline.

• 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.

Exclusion Criteria:

• Histologically or cytologically confirmed small cell esophageal carcinoma, esophageal adenocarcinoma or other mixed carcinoma.

• Prior anti-cancer treatment, including but not limited to, chemotherapy and/or radiation therapy, immunotherapy, and investigational agents.

• 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.