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

  • STATUS
    Recruiting
  • End date
    Oct 30, 2026
  • participants needed
    600
  • sponsor
    AstraZeneca
Updated on 11 September 2021
carcinoma
fluorouracil
squamous cell carcinoma
capecitabine
durvalumab

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).

Description

Approximately 600 patients with locally advanced, unresectable ESCC (AJCC 8th cStage II-IVA) will be randomized in a 2:1 ratio to receive either durvalumab + dCRT or placebo + dCRT. The primary objectives of this study are to assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in terms of progression free survival (PFS, per RECIST 1.1 as assessed by BICR) in all randomized patients (intent-to-treat [ITT] population) and PFS in patients with PD-L1 high tumors (PD-L1 High population).

Details
Condition Esophageal Cancer, Squamous cell carcinoma, Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Esophagus
Treatment Placebo, Radiation, durvalumab, cisplatin + fluorouracil, cisplatin + capecitabine
Clinical Study IdentifierNCT04550260
SponsorAstraZeneca
Last Modified on11 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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