Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patie⦠(NCT04550260) | Clinical Trial Compass
Active ā Not RecruitingPhase 3
Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
United States640 participantsStarted 2020-10-19
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR