drugset / Trial / NCT05332002
sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)
NaSingle-groupOpen-labelTreatment
Summary
The primary objective is to determine the clinical efficacy of treatment regimen in terms of objective response rate (ORR). The secondary objectives is to determine the clinical efficacy of the study treatment in terms of progression free survival (PFS) and overall survival (OS). Additionally, to characterize the safety and toxicity profile of the study treatment as measured by the adverse event rates.
Timeline
- Start
- 2022-07-13
- Primary completion
- 2026-08-01
- Completion
- 2026-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | — |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | — |