Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 75

Comparing treatments for early-stage NK/T cell lymphoma

Official title: 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)

Run by Sun Yat-sen University · NCT04365036 · Data updated 2026-11-12

This study is testing whether adding a new antibody treatment to the standard therapy helps people with early-stage NK/T cell lymphoma do better.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment207 (estimated)
SponsorSun Yat-sen University
Academic / other
Drugs / interventionschemotherapy, immunotherapy, toripalimab
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedMay 3, 2020
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedMarch 13, 2025
Trial IDNCT04365036 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-75 with newly diagnosed stage I/II extranodal natural killer/T-cell lymphoma, nasal type.

Probably not a fit

Patients with aggressive NK cell leukemia or those who have previously received treatment for lymphoma may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of sequential chemoradiotherapy with or without the PD-1 antibody, toripalimab, in patients with newly diagnosed early-stage extranodal natural killer/T-cell lymphoma, nasal type. It is a multicenter, phase 3 randomized trial that will involve multiple treatment centers. Participants will receive either the standard treatment or the treatment combined with toripalimab to determine which approach yields better outcomes.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with early-stage NK/T cell lymphoma.

How similar studies have gone: Other studies have shown promise in using PD-1 antibodies in similar contexts, suggesting potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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;

Where it's running

  • Guangdong General Hospital
    Guangzhou, Guangdong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.