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)
Plain-language summary
This trial is testing an asparaginase-based regimen for patients with extranodal NK/T-cell lymphoma (ENKTL) who have been newly diagnosed and have not yet received treatment. This is a Phase 3 trial, which means the treatment is being compared to the current standard of care to determine if it works better. Patients are randomly assigned to different treatment groups. The study looks at both safety and how well the treatment controls the lymphoma. This trial does not currently have sites in the United States.
Who can join (key eligibility)
- Age 18 Years to 75 Years years
- Newly diagnosed, not yet treated
- Must be well enough for treatment (adequate performance status)
Final eligibility is determined by the trial team. This list is a starting point only.
What's being tested
Toripalimab (DRUG): toripalimab 240mg, d1, intravenous drip | Pegaspargase (DRUG): pegaspargase, 2000U/m2, d1, intravenous drip | Gemcitabine (DRUG): gemcitabine, 1000mg/m2, d1,d8, intravenous drip | Oxaliplatin (DRUG): oxaliplatin, 130mg/m2, d1, intravenous drip, | Definitive intensity-modulated radiotherapy (IMRT) (RADIATION): Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25\~26 days
Toripalimab, Pegaspargase, Gemcitabine, Oxaliplatin, Definitive intensity-modulated radiotherapy (IMRT)
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details