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Clinical Trials in the USA / NCT04550260
Active, not recruiting Phase 3

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

NCT04550260 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2020-10-19
Last updated
2026-05-13

Condition(s) studied

Esophageal Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

DurvalumabPlacebocisplatin + fluorouracilcisplatin + capecitabineRadiation

Durvalumab: Durvalumab intravenous infusion

Placebo: Durvalumab matching placebo for intravenous infusion

cisplatin + fluorouracil: cisplatin + fluorouracil, as per Standard of Care

cisplatin + capecitabine: cisplatin + capecitabine, as per Standard of Care

Radiation: 50-64Gy in total

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (133)

FacilityCityRegionStatus
Research Site Atlanta Georgia
Research Site Louisville Kentucky
Research Site Dallas Texas
Research Site Fairfax Virginia
Research Site Morgantown West Virginia
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
Research Site Greater Sudbury Ontario
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 Chongqing China
Research Site Fuzhou China
Research Site Fuzhou China
Research Site Guangzhou China
Research Site Guangzhou China
Research Site Hangzhou China
Research Site Hefei China
Research Site Huai'an China
Research Site Jieyang China
Research Site Jinan China
Research Site Kunming China
Research Site Liangyugang China
Research Site Nantong China
Research Site Qingdao China
Research Site Quanzhou China

+ 93 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04550260 on ClinicalTrials.gov ↗ ← All trials in the USA