drugset / Trial / NCT04736485
Perioperative Treatment in Resectable Gastric Cancer With Spartalizumab (PDR001) in Combination With Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT)
NaSingle-groupOpen-labelTreatment
Summary
Multicenter, open-label, non randomized, phase 2 trial in resectable gastric or gastroesophageal junction adenocarcinoma: Perioperative Treatment by Spartalizumab (PDR001) in Combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT)
Timeline
- Start
- 2021-06-28
- Primary completion
- 2024-03-01
- Completion
- 2025-11-27
Publications
- Results Dos Santos M, Lequesne J, Piessen G, Leconte A, Guimbaud R, Pernot S, Bouche O, Hiret S, Soularue E, Tougeron D, Dahan L, Le Sourd S, Borg C, Samalin E, Corbinais S, Parzy A, Guilloit JM, Varatharajah S, Brachet PE, Dorbeau M, Galais MP, Desgrippes R, Clarisse B. Perioperative treatment in resectable gastric cancer with spartalizumab in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT): Results from the GASPAR phase 2 study. Eur J Cancer. 2026 Mar 11;236:116258. doi: 10.1016/j.ejca.2026.116258. Epub 2026 Jan 30.
- Klute KA, Shah MA. Evolving Therapeutics for Resectable Esophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257044. doi: 10.6004/jnccn.2025.7044.
- Dos Santos M, Lequesne J, Leconte A, Corbinais S, Parzy A, Guilloit JM, Varatharajah S, Brachet PE, Dorbeau M, Vaur D, Weiswald LB, Poulain L, Le Gallic C, Castera-Tellier M, Galais MP, Clarisse B. Perioperative treatment in resectable gastric cancer with spartalizumab in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT): a phase II study (GASPAR). BMC Cancer. 2022 May 12;22(1):537. doi: 10.1186/s12885-022-09623-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | perioperative treatment | Unknown | 400 mg | Intravenous |
| Background | Docetaxel | Small molecule | 50 mg/m2 | Intravenous |
| Background | Fluorouracile | Unknown | 2600 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |