Phase 3 Study Comparing Chemoradiotherapy With or Without Toripalimab in Early-Stage Extranodal NKT Cell Lymphoma, Nasal Type

What this Trial Is About

Researchers are evaluating the safety and effectiveness of sequential chemoradiotherapy with or without the addition of toripalimab, a PD-1 antibody, in people newly diagnosed with early-stage extranodal natural killerT-cell lymphoma, nasal type ENKTL. This phase 3, randomized, multi-center clinical trial aims to compare these two treatment approaches to better understand their impact on this specific lymphoma type. Participants are assigned to one of two groups. One group receives toripalimab combined with induction chemotherapy using pegaspargase, gemcitabine, and oxaliplatin every three weeks for four cycles prior to radiation. They then receive intensity-modulated radiotherapy IMRT and continue toripalimab every three weeks during and after radiation for a total of 13 cycles. The other group receives the same chemotherapy and radiation schedule without toripalimab. Throughout the study, participants undergo regular evaluations to monitor treatment response and safety. Researchers will measure progression-free survival over three years as the primary outcome. Secondary outcomes include complete remission rate, overall response rate, overall survival, recurrence-free survival, event-free survival, and disease-free survival, all tracked up to three years or six months as appropriate. The study follows participants from the start of treatment through multiple years to assess long-term outcomes.

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)