esophageal cancer Unresectable Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Patients will be randomized in a 2:1 ratio to receive either durvalumab + dCRT
or placebo + dCRT:
- Durvalumab + dCRT: Durvalumab 1500 mg Q4W will be administered concurrently
with dCRT. Patients wi
Sponsors
Astra Zeneca
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objectives: - To assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in all randomized patients based on PFS (per RECIST 1.1 as assessed by BICR) - To assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in patients with PD-L1 High tumors based on PFS (per RECIST 1.1 as assessed by BICR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary Objectives: - To assess the efficacy of durvalumab + dCRT compared to placebo + dCRT in terms of OS in all randomized patients - To assess the efficacy of durvalumab + dCRT compared to placebo + dCRT in terms of OS in patients with PD-L1 High tumors | — |
Countries
Netherlands
Outcome results
None listed