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Phase 2RecruitingPriority 3 · Moderate priorityNCT06314334

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

ClinicalTrials.gov

Plain-language summary

This Phase 2 trial is studying Sintilimab+Pegaspargase, P-GemOx, and other medications for people 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
  • 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

Sintilimab+Pegaspargase (DRUG): 1. Sintilimab, 200mg intravenous drip, on day 1; 2. pegaspargase, 2000U/m\^2, capped at 3750U, intramuscular, day 1; | P-GemOx (DRUG): 1. pegaspargase 2000U/m\^2, capped at 3750U on day 1, intramuscular; 2. gemcitabine 1.0g/m\^2 on day 1 and day 8, intravenous drip; 3. oxaliplatin 130mg/m\^2 on day 1, intravenous drip | GELAD (DRUG): 1. gemcitabine 1.0g/m\^2 on day 1, intravenous drip; 2. etoposide 60mg/m\^2 on day 1-3, intravenous drip; 3. pegaspargase 2000U/m\^2, capped at 3750U on day 1,intramuscular; 4. dexamethasone 20mg on day 1-4, intravenous drip. | IMRT (RADIATION): Intensity modulated radiotherapy (50-56Gy)

Drugs / treatments
Sintilimab+Pegaspargase, P-GemOx, GELAD, IMRT
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details
TrialCompass — Clinical Trial Summary

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

NCT06314334

Phase: Phase 2 | Status: Recruiting | Priority: Medium

Plain-language summary

This Phase 2 trial is studying Sintilimab+Pegaspargase, P-GemOx, and other medications for people 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
  • Must be well enough for treatment (adequate performance status)

What's being tested

Sintilimab+Pegaspargase (DRUG): 1. Sintilimab, 200mg intravenous drip, on day 1; 2. pegaspargase, 2000U/m\^2, capped at 3750U, intramuscular, day 1; | P-GemOx (DRUG): 1. pegaspargase 2000U/m\^2, capped at 3750U on day 1, intramuscular; 2. gemcitabine 1.0g/m\^2 on day 1 and day 8, intravenous drip; 3. oxaliplatin 130mg/m\^2 on day 1, intravenous drip | GELAD (DRUG): 1. gemcitabine 1.0g/m\^2 on day 1, intravenous drip; 2. etoposide 60mg/m\^2 on day 1-3, intravenous drip; 3. pegaspargase 2000U/m\^2, capped at 3750U on day 1,intramuscular; 4. dexamethasone 20mg on day 1-4, intravenous drip. | IMRT (RADIATION): Intensity modulated radiotherapy (50-56Gy)

Drugs / treatments: Sintilimab+Pegaspargase, P-GemOx, GELAD, IMRT

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Randomized, open-label

Enrollment target: 210 patients

Primary endpoint: PFS24

Ages: 18 Years to 75 Years

Start date: 2024-03-04 | Est. completion: 2028-12-30

Locations

0 US sites · 7 total

Contact

Rong Tao, MD | rtao@shca.org.cn | 8621-64175590

Sponsor: Fudan University (OTHER)

Tags

ENKTL · any

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT06314334

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