Study Comparing Durvalumab and Placebo with Chemoradiation Therapy for Patients with Advanced Esophageal Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT04550260
This clinical trial is testing whether adding the drug durvalumab to standard chemoradiation therapy is more effective than using a placebo in treating patients with advanced esophageal squamous cell carcinoma (ESCC) that cannot be surgically removed.
Patient Parameters
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Program Overview
This study is designed to find out if the drug durvalumab, when used with standard chemoradiation therapy, can help control advanced esophageal squamous cell carcinoma (ESCC) better than a placebo. The trial involves patients whose cancer cannot be removed by surgery and aims to see if this combination can improve the time patients live without the cancer getting worse.
Description
In this study, about 600 patients with advanced esophageal squamous cell carcinoma (ESCC) that cannot be surgically removed will participate. They will be randomly assigned to receive either durvalumab with chemoradiation therapy or a placebo with chemoradiation therapy. The main goal is to see if durvalumab can help patients live longer without their cancer progressing, especially in those with high levels of a protein called PD-L1. The study will also monitor the safety of the treatment combination.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of esophageal squamous cell carcinoma that is locally advanced and cannot be removed by surgery.
- Must be suitable for chemoradiation therapy and either cannot have surgery or choose not to have it.
- Must have at least one tumor that can be measured by scans.
- Must provide a tumor sample for testing PD-L1 levels.
- Must be in good general health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must have adequate organ and bone marrow function.
- Must have a life expectancy of more than 3 months.
Exclusion Criteria
- Have a different type of esophageal cancer, such as small cell or adenocarcinoma.
- Have received previous treatment for esophageal squamous cell carcinoma.
- Have a high risk of severe complications like perforation or bleeding.
- Have had an organ transplant from another person.
- Have active or past autoimmune or inflammatory diseases.
- Have uncontrolled health issues.
- Have a history of another type of cancer.
- Have active infections like tuberculosis, hepatitis B or C, or HIV.
- Have known allergies to the study drugs or their ingredients.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 30308 | Atlanta | Georgia |
| Research Site | 40217 | Louisville | Kentucky |
| Research Site | 75390 | Dallas | Texas |
| Research Site | 22031 | Fairfax | Virginia |
| Research Site | 26506 | Morgantown | West Virginia |
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