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

Starting soon · Phase 2

Conditions studied: Extranodal NK/T-cell Lymphoma

In brief

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.

Key facts

Study ID

NCT07554482

Run by

Beijing Tongren Hospital

People needed

34

Starts

2026-05-15

Expected to finish

2029-04-30

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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) infection.
• Severe complications, such as uncontrolled diabetes mellitus and severe cardiopulmonary diseases.
• Pregnant or lactating women.
• Hypersensitivity or contraindication to any investigational drugs in this study.
• Concurrent participation in other interventional clinical trials.

Where it is running

• Beijing Tongren Hospital, Capital Medical University — Beijing, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.