drugset / Trial / NCT06314334

Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK/T-cell Lymphoma

NCT06314334

Phase 2 Recruiting 210 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

Extranodal NK/T-cell lymphoma, nasal type (NKTCL) is a common malignant tumor in East Asian populations, often starting in the nasal cavity and spreading to other organs. Associated with EBV infection, NKTCL is aggressive. Early-stage patients typically receive chemo and radiotherapy, with promising outcomes. Recent studies show the potential of immune checkpoint inhibitors in NKTCL treatment. However, optimal treatment sequencing and efficacy remain unclear. This study aims to compare three strategies: (A) Pegaspargase with Sintilimab and radiotherapy; (B) chemo then radiotherapy (PGemOx); (C) sandwich chemoradiotherapy (GELAD). The goal is to identify the best treatment based on 24-month progression-free survival.

Timeline

Start
2024-03-04
Primary completion
2026-12-30
Completion
2028-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 20 mg Intravenous
Subject Etoposide Small molecule 60 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1 g Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject Pegaspargase Protein / enzyme biologic 2000 iu Intramuscular
Subject Sintilimab Monoclonal antibody 200 mg Intravenous