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Phase 3RecruitingPriority 1 · Highest priorityNCT04365036

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)

ClinicalTrials.gov

Plain-language summary

This Phase 3 trial is comparing different first-line treatment approaches for people newly diagnosed with NK/T-cell lymphoma. Patients are randomly assigned to different treatment groups to see which approach works best. This trial does not currently list US sites.

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

Drugs / treatments
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

At a glance

Phase
Phase 3
Status
Recruiting
Design
Randomized, open-label
Enrollment target
207 patients
Primary endpoint
progression free survival (PFS)
Ages
18 Years to 75 Years
Start date
2020-05-03
Est. completion
2028-12-31

Locations

0 US sites · 1 total

No US sites currently listed.

Contact

Sponsor
Sun Yat-sen University (OTHER)
Contact
Qingqing Cai, MD | caiqq@sysucc.org.cn | 0086-20-87342823

Tags

ENKTLNewly diagnosed
TrialCompass — Clinical Trial Summary

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)

NCT04365036

Phase: Phase 3 | Status: Recruiting | Priority: Highest

Plain-language summary

This Phase 3 trial is comparing different first-line treatment approaches for people newly diagnosed with NK/T-cell lymphoma. Patients are randomly assigned to different treatment groups to see which approach works best. This trial does not currently list US sites.

Who can join

  • Age 18 Years to 75 Years years
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

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

Drugs / treatments: 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

Trial design

Randomized, open-label

Enrollment target: 207 patients

Primary endpoint: progression free survival (PFS)

Ages: 18 Years to 75 Years

Start date: 2020-05-03 | Est. completion: 2028-12-31

Locations

0 US sites · 1 total

Contact

Qingqing Cai, MD | caiqq@sysucc.org.cn | 0086-20-87342823

Sponsor: Sun Yat-sen University (OTHER)

Tags

ENKTL · Newly diagnosed

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT04365036

Prepared using TrialCompass (trialcompass.com) on June 19, 2026. For informational purposes only. Always discuss with your healthcare team.
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Data sourced from ClinicalTrials.gov.

For informational purposes only. Not medical advice — always consult your healthcare team.

Built with care for the rare cancer community.

Data last updated: June 2026

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