Clinical trial · Interventional
Selinexor Combined With Reduced-Dose Radiotherapy For Early-Stage Extranodal NK/T-Cell Lymphoma
A Prospective, Single-Arm, Multicenter, Phase II Clinical Study of Selinexor Combined With Reduced-Dose Radiotherapy in the Treatment of Early-Stage Extranodal NK/T-Cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extranodal NK/T-cell Lymphoma | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine (GEM) | Drug | Gemcitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Pegaspargase (PEG) Asparaginase | Drug | — | UNRESOLVED |
| radiotherapy | Radiation | — | UNRESOLVED |
| Selinexor | Drug | Selinexor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment arm
- description
- Patients will first receive 4 cycles of P-GEMOX induction chemotherapy. Pegaspargase at a dose of 2500 IU/m² (maximum dose not exceeding 3750 IU) is administered via intramuscular injection on Day 1 of each 21-day cycle. Gemcitabine 1000 mg/m² is given by intravenous infusion on Day 1 and Day 8 of each 21-day cycle. Oxaliplatin 130 mg/m² is administered intravenously on Day 1 of each 21-day cycle. A total of 4 cycles will be completed. Following induction chemotherapy, patients will receive consolidation therapy consisting of selinexor combined with reduced-dose radiotherapy. Radiotherapy will be delivered at a total dose of 40 Gy in 20 fractions (2 Gy per fraction), once daily, 5 fractions per week, over 4 weeks. Radiation therapy will be performed using intensity-modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT). The target volume includes the gross tumor volume (GTV) of the primary lesion before chemotherapy, with a clinical target volume (CTV) margin ex
- interventionNames
- Drug: Pegaspargase (PEG) Asparaginase
- Drug: Gemcitabine (GEM)
- Drug: Oxaliplatin
- Drug: Selinexor
- Radiation: radiotherapy
Primary outcomes (1)
- measure
- Complete response (CR) rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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) 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.
References
Publications (0)
Data not yet available