BridgeMD
Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With locally advanced, Unresectable ESCC
EU CTIS ID: 2023-506413-22-00
What this study is testing
To assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in terms of PFS using BICR assessments according to RECIST 1.1 in patients with PD-L1 TAP≥1% tumors
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • 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.
You likely can't join if
- • 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 interventions or any of the study interventions excipients.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Korea, Republic of
- Taiwan
- Thailand
- Turkey
- Mexico
- Vietnam
- China
- Brazil
- Japan
- Russian Federation
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Korea, Republic of; Taiwan; Thailand; Turkey; Mexico and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.