Actively Recruiting
PD-1 Antibody-based Therapy With Concurrent RT for Early-stage NKTCL
Led by Ruijin Hospital · Updated on 2026-03-20
47
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PD-1 Antibody-based Therapy With Concurrent RT for Early-stage NKTCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed extranodal NK/T-cell lymphoma, nasal type according to 2022 WHO classification
- No prior anti-lymphoma therapy
- Age 18 years or older
- Life expectancy greater than 3 months
- Ann Arbor stage I-II
- At least one measurable or evaluable disease site confirmed by biopsy before treatment
- ECOG performance status score between 0 and 2
- Signed informed consent form
- Willingness and ability to comply with study protocol
- Adequate bone marrow, liver, and kidney function as defined by specific blood count and chemistry levels
- Availability of tumor tissue samples (fresh or archived)
- Women of childbearing potential agree to use contraception during treatment
- Male participants agree to abstain or use barrier contraception
You will not qualify if you...
- Advanced disease (Ann Arbor stage III-IV)
- Nonnasal-type NK/T-cell lymphoma
- History of autoimmune disease requiring systemic treatment within past 2 years, except stable autoimmune hypothyroidism or type 1 diabetes
- History of other invasive cancers within past 3 years not treated curatively or currently receiving anticancer therapy
- History of non-infectious pneumonia requiring corticosteroids, interstitial lung disease, or active non-infectious pneumonia
- Active infections requiring systemic treatment, including active tuberculosis or viral infections other than hepatitis B and C
- Severe cardiovascular disease within past 3 months
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents
- Use of live-attenuated vaccines within 4 weeks before treatment or during study
- Use of systemic immunosuppressive agents within 2 weeks before treatment or planned use during study
- Central nervous system involvement
- History of allogeneic tissue or organ transplantation
- History of severe allergic reactions to PD-1 monoclonal antibodies or golidocitinib
- Any other factors that may affect study compliance as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, China
Actively Recruiting
Research Team
W
Weili Zhao
CONTACT
P
Pengpeng Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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