drugset / Trial / NCT04365036
A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy with or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this randomized, multi-center,phase Ⅲ clinical trail is to compare the safety and efficacy of sequencial chemoradiotherapy with or without toripalimab (PD-1 antibody) for newly diagnosed early-stage extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)
Timeline
- Start
- 2020-05-03
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Background | Pegaspargase | Protein / enzyme biologic | 2000 unknown | Intravenous |