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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)

RecruitingPhase 3Ages 18 Years - 75 YearsAllSun Yat-sen University
NCT04365036 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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)

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📋 Eligibility rules (as published)
Inclusion Criteria: * biopsy proved extranodal natural killer/T-cell lymphoma, nasal type; * newly diagnosed stage I/II patients; * at least one evaluable lesion； * ECOG PS 0-2; * 18-75 years; without other malignancy; * proper functioning of the major organs. Exclusion Criteria: * hemophagocytic syndrome or aggressive NK cell leukemia; * involvement of central nervous system; * previously received treatment of chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；
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What it tests

  • Toripalimab
  • Pegaspargase
  • Gemcitabine
  • Oxaliplatin
  • Definitive intensity-modulated radiotherapy (IMRT)
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Where

1 site
Guangdong General Hospital
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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