drugset / Trial / NCT05319639
Phase I/II Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of the phase I/II study is to establish the safety of Combination of Irinotecan and paclitaxel with 5-FU, leucovorin, oxaliplatin and Tislelizumab.
Timeline
- Start
- 2023-02-16
- Primary completion
- 2024-10-31
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 135 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 150 mg/m2 | — |
| Subject | Levoleucovorin | Unknown | 200 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 45 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 67.5 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 90 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 112.5 mg/m2 | — |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | — |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | — |