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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 207 (estimated) |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, toripalimab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | May 3, 2020 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | March 13, 2025 |
| Trial ID | NCT04365036 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
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Guangdong General Hospital
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Qingqing Cai, MD
- Email: caiqq@sysucc.org.cn
- Phone: 0086-20-87342823
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Propranolol with Toripalimab and Platinum Chemo before/around surgery in NSCLC
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Neoadjuvant Cryo-Thermal Ablation with Toripalimab and Chemo for Resectable NSCLC
This study tests whether using Cryo-Thermal Ablation before chemo-immunotherapy helps people with resectable NSCLC see better outcomes.
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Rimegepant plus toripalimab in advanced urothelial cancer after standard therapy
This small, early-stage study tests whether combining rimegepant with toripalimab is safe and shows signs of activity in adults with advanced urothelial cancer that did not respond to prior treatment.
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SABR with Axitinib and Toripalimab for oligometastatic kidney cancer
This phase 2 trial tests whether giving SABR radiation together with axitinib and toripalimab can shrink tumors and help patients with up to five metastatic sites from clear cell renal cell carcinoma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.