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NCT04550260 · ClinicalTrials.gov registry record · Phase 3
Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
A Phase 3 study of Esophageal Squamous Cell Carcinoma, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 640
- Enrollment target
- 20
- Study locations
NCT04550260: Active Phase 3 study of Esophageal Squamous Cell Carcinoma, sponsored by AstraZeneca.
NCT04550260 is a Phase 3 study of Esophageal Squamous Cell Carcinoma that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 640 participants, above the 351-participant average among 22 other Esophageal Squamous Cell Carcinoma trials with a reported enrollment target (82% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04550260, a Phase 3 study of Esophageal Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 640 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
To assess the efficacy in terms of PFS in PD-L1 High population
Conditions Studied
Interventions
- DRUG Placebo
- RADIATION Radiation
- DRUG Durvalumab
- DRUG cisplatin + fluorouracil
- DRUG cisplatin + capecitabine
Study Locations (20)
Other
- Research Site - Brussels
- Research Site - Charleroi
- Research Site - Liège
- Research Site - Namur
- Research Site - Barretos
- Research Site - Fortaleza
- Research Site - Porto Alegre
- Research Site - Porto Alegre
- Research Site - Rio de Janeiro
- Research Site - São José do Rio Preto
- Research Site - Vitória
- Research Site - Anyang
- Research Site - Beijing
Ontario
- Research Site - Barrie
- Research Site - Greater Sudbury
Georgia
- Research Site - Atlanta
Kentucky
- Research Site - Louisville
Texas
- Research Site - Dallas
Virginia
- Research Site - Fairfax
West Virginia
- Research Site - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 640 participants |
| Start Date | 2020-10-19 |
| Est. Completion | 2026-06-02 |
| Phase | Phase 3 |
What the registry record for NCT04550260 still lists
NCT04550260 is an interventional study that assigns participants to a tested intervention. The registered 640 participants enrollment target is mid-sized for trials with a published cap, above the 351-participant average among 22 other Esophageal Squamous Cell Carcinoma trials with a reported enrollment target (82% higher).
The record links to 1 condition, with Esophageal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT04550260 names 20 study sites across 7 states, led by Other, Ontario, Georgia.
Frequently Asked Questions
What is clinical trial NCT04550260 about?
NCT04550260 is a clinical study titled "Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC". 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).
What is the current status of trial NCT04550260?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 640 participants. The study started on 2020-10-19. Estimated completion is 2026-06-02.
What conditions does trial NCT04550260 study?
This clinical trial studies the following conditions: Esophageal Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04550260?
The interventions under investigation include: Placebo (DRUG), Radiation (RADIATION), Durvalumab (DRUG), cisplatin + fluorouracil (DRUG), cisplatin + capecitabine (DRUG).
Who is sponsoring clinical trial NCT04550260?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04550260 being conducted?
This trial has 20 study locations across Georgia, Kentucky, Texas, Virginia, West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04550260's enrollment target sits among peer trials
640 6th of 22 higher than 17 of 22 other Esophageal Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Esophageal Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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