Clinical Trial

Study of Atezolizumab + FLOT vs. FLOT Alone in Patients With GC/GEJ and High Immune Responsiveness

Study acronym: DANTE
Active, Not Recruiting Phase 2
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Summary
This is a multicenter, randomized, controlled, open-label study comparing perioperative atezolizumab with FLOT chemotherapy versus FLOT alone in patients with locally advanced, operable adenocarcinoma of the stomach or GEJ with high immune responsiveness.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2018-01-29; most recent amendment 2025-07-22.
Status change: Recruiting → Active, Not Recruiting 2025-07-22
Status change: Active, Not Recruiting → Recruiting 2023-08-08
Status change: Recruiting → Active, Not Recruiting 2020-11-30
Status change: Not Yet Recruiting → Recruiting 2018-09-17
Trial Details
NCT Number NCT03421288
Lead Sponsor Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Collaborators: Roche Pharma AG
Conditions Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Enrollment 677 participants
Start Date 2018-09-14
Primary Completion 2027-05-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-25