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Phase 2RecruitingPriority 3 · Moderate priorityNCT07380984

PD-1 Antibody-based Therapy With Concurrent RT for Early-stage NKTCL

ClinicalTrials.gov

Plain-language summary

This Phase 2 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 or older
  • 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

PD-1 antibody (DRUG): Administration of PD-1 mAb will start on Day 1 of radiotherapy (C1D1) at a dose of 200 mg via intravenous infusion over 30 minutes or longer, once every 3 weeks, cycle 1 - cycle 6 | radiotherapy (RADIATION): Concurrent standard involved-site radiotherapy (ISRT) | Chidamide (DRUG): The dosage of chidamide will follow a dose-escalation design: 20 mg twice weekly (biw) in the first stage, then escalated to 30 mg biw, using the Bayesian Optimal Interval (BOIN) design to determine the recommended dose, followed by dose expansion in the second stage, every 3 weeks, cycle 4 - cycle 6. | golidocitinib (DRUG): Golidocitinib will be administered at a dose of 150 mg once daily (qd), every 3 weeks, cycle 4 - cycle 6.

Drugs / treatments
PD-1 antibody, radiotherapy, Chidamide, golidocitinib
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

At a glance

Phase
Phase 2
Status
Recruiting
Design
Non-randomized, open-label
Enrollment target
47 patients
Primary endpoint
2-year progression-free survival rate
Ages
18 Years to —
Start date
2026-03
Est. completion
2029-02

Locations

0 US sites · 1 total

No US sites currently listed.

Contact

Sponsor
Ruijin Hospital (OTHER)
Contact
Weili Zhao | zwl_trial@163.com | +610707 +862164370045

Tags

ENKTLNewly diagnosed
TrialCompass — Clinical Trial Summary

PD-1 Antibody-based Therapy With Concurrent RT for Early-stage NKTCL

NCT07380984

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

Plain-language summary

This Phase 2 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 or older
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

What's being tested

PD-1 antibody (DRUG): Administration of PD-1 mAb will start on Day 1 of radiotherapy (C1D1) at a dose of 200 mg via intravenous infusion over 30 minutes or longer, once every 3 weeks, cycle 1 - cycle 6 | radiotherapy (RADIATION): Concurrent standard involved-site radiotherapy (ISRT) | Chidamide (DRUG): The dosage of chidamide will follow a dose-escalation design: 20 mg twice weekly (biw) in the first stage, then escalated to 30 mg biw, using the Bayesian Optimal Interval (BOIN) design to determine the recommended dose, followed by dose expansion in the second stage, every 3 weeks, cycle 4 - cycle 6. | golidocitinib (DRUG): Golidocitinib will be administered at a dose of 150 mg once daily (qd), every 3 weeks, cycle 4 - cycle 6.

Drugs / treatments: PD-1 antibody, radiotherapy, Chidamide, golidocitinib

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 47 patients

Primary endpoint: 2-year progression-free survival rate

Ages: 18 Years to —

Start date: 2026-03 | Est. completion: 2029-02

Locations

0 US sites · 1 total

Contact

Weili Zhao | zwl_trial@163.com | +610707 +862164370045

Sponsor: Ruijin Hospital (OTHER)

Tags

ENKTL · Newly diagnosed

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT07380984

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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