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NCT07380984
A Prospective Study to Evaluate the Efficacy and Safety of PD-1 Monoclonal Antibody-based Stratified Targeted Therapy Combined With Concurrent Radiotherapy for Patients With Treatment-naive Early-stage Nasal-type NK/T-cell Lymphoma
Phase 2 trial testing PD-1 antibody in Natural Killer/T-cell Lymphoma in 47 participants. Currently enrolling.
1 February 2029
Quick facts
| Lead sponsor | Ruijin Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 47 |
| Start date | 1 March 2026 |
| Primary completion | 1 February 2029 |
| Estimated completion | 1 February 2029 |
| Sites | 1 location across China |
Drugs / interventions tested
- PD-1 antibody — full drug profile →
- radiotherapy — full drug profile →
- Chidamide — full drug profile →
- golidocitinib — full drug profile →
Conditions studied
- Natural Killer/T-cell Lymphoma — all drugs for Natural Killer/T-cell Lymphoma →
Sponsor
Ruijin Hospital
Who can join
18 and older, any sex, with Natural Killer/T-cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
2-year progression-free survival rate
Time frame: Baseline up to data cut-off (up to 24 months).
Progression-free survival is defined as the time from registration to the first occurrence of disease progression or relapse, using 2014 Lugano criteria, or death from any cause. For patients who received subsequent treatment after the interim assessment, the endpoint shall be defined by the event first occurring after the initiation of subsequent treatment.
Sponsor's own description
Natural killer/T-cell lymphoma (nasal type) is a mature T/NK-cell lymphoma closely associated with Epstein-Barr virus (EBV), with a high prevalence among populations in Asia and South America. It primarily occurs at extranodal sites, including the nasal/paranasal regions, skin, gastrointestinal tract, and other organs. This study focuses on previously untreated patients with early-stage NKTCL (nasal type), exploring a response-adapted comprehensive therapeutic strategy that combines PD-1 monoclonal antibody-based stratified targeted therapy with concurrent radiotherapy. The aim is to provide integrated management for early-stage extranodal NK/T-cell lymphoma (nasal type), and reduce toxicity while improving overall treatment outcomes for patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07380984
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Natural Killer/T-cell Lymphoma
Currently open trials in the same condition.
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- NCT04763616 — Study of Isatuximab and Cemiplimab in Relapsed or Refractory Natural Killer/T-cell Lymphoid Malignancy · Phase 2 · recruiting
Other Ruijin Hospital trials
Trials by the same sponsor.
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- NCT07511114 — A Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated DEL Under the Guidance of Genotyp · Phase 3 · not yet recruiting
- NCT07514169 — The Efficacy and Safety of Pola-ZR-Glo in Older Treatment-naive Patients With LBCL · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07380984 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ruijin Hospital
- Last refreshed: 19 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07380984.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing