Not Yet RecruitingPhase 2

Selinexor Combined With Reduced-Dose Radiotherapy For Early-Stage Extranodal NK/T-Cell Lymphoma

China34 participantsStarted 2026-05-15

Plain-language summary

Extranodal NK/T-cell lymphoma (ENKTCL) is an Epstein-Barr virus-associated non-Hodgkin lymphoma with high incidence in Asia and Latin America. Approximately 70% of patients present with early-stage (I-II) disease confined to the upper aerodigestive tract. Radiotherapy at 50-56 Gy is the standard curative treatment, but high-dose radiotherapy causes severe toxicities including oral mucositis and xerostomia, while radiotherapy alone yields high systemic recurrence rates. Previous studies have confirmed the efficacy of P-GEMOX induction chemotherapy, verified the feasibility of reduced-dose radiotherapy in patients achieving complete response after chemotherapy, and demonstrated the radiosensitizing effect of selinexor via inhibiting IRF3-BARD1-BRCA1-mediated DNA damage repair. Moreover, international evidence supports the efficacy of 40 Gy radiotherapy combined with chemotherapy. Accordingly, this study hypothesizes that selinexor combined with 40 Gy reduced-dose radiotherapy following P-GEMOX induction chemotherapy can achieve equivalent efficacy to standard-dose radiotherapy, while markedly decreasing radiotherapy-related toxicities. This trial innovatively applies selinexor as a radiosensitizer in ENKTCL, fulfills the unmet clinical demand for efficacy-preserving toxicity reduction, and is well supported by preliminary data.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 18 to 75 years, regardless of gender. * Pathologically confirmed extranodal NK/T-cell lymphoma (ENKTCL). * Ann Arbor stage I-II disease with primary lesion located in the nasal cavity or upper aerodigestive tract (UADT). * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. * Treatment-naïve patients with no prior radiotherapy, chemotherapy or targeted therapy. * Adequate major organ function as follows: * Hematopoietic function: absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count (PLT) ≥100×10⁹/L, hemoglobin (Hb) ≥90 g/L. * Hepatic function: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), alanine transaminase (ALT) / aspartate transaminase (AST) ≤2.5×ULN. * Renal function: serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance rate ≥60 mL/min. * Cardiac function: left ventricular ejection fraction (LVEF) ≥50%. * Expected overall survival ≥6 months. * Voluntarily sign the written informed consent form. Exclusion Criteria: * Non-nasal type ENKTCL, or primary lesions outside the upper aerodigestive tract (UADT), including skin, gastrointestinal tract, lung and other sites. * Patients with Ann Arbor stage III-IV disease. * Central nervous system involvement. * History of prior malignant tumors, excluding non-melanoma skin cancer or cervical carcinoma in situ cured for more than 5 years. * Active infections, including active hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV)…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete response (CR) rate

Timeframe: From the day of initiation of treatment to 8 weeks after completion of radiotherapy.

Trial details

NCT IDNCT07554482

SponsorBeijing Tongren Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Liang Wang, M.D.

+861058266633 wangliangtrhos@126.com

View on ClinicalTrials.gov More Extranodal NK/T-cell Lymphoma trials