[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635576":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":42,"centralContacts":46,"locations":56,"responsibleParty":69,"collaborators":24,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":24,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":24,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":96,"whyStopped":24,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Beijing Tongren Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"treatment arm","EXPERIMENTAL","Patients will first receive 4 cycles of P-GEMOX induction chemotherapy. Pegaspargase at a dose of 2500 IU\u002Fm² (maximum dose not exceeding 3750 IU) is administered via intramuscular injection on Day 1 of each 21-day cycle. Gemcitabine 1000 mg\u002Fm² is given by intravenous infusion on Day 1 and Day 8 of each 21-day cycle. Oxaliplatin 130 mg\u002Fm² is administered intravenously on Day 1 of each 21-day cycle. A total of 4 cycles will be completed.\n\nFollowing 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",[13,14,15,16,17],"Drug: Pegaspargase (PEG) Asparaginase","Drug: Gemcitabine (GEM)","Drug: Oxaliplatin","Drug: Selinexor","Radiation: radiotherapy",[19,25,29,33,37],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Pegaspargase (PEG) Asparaginase","Pegaspargase at a dose of 2500 IU\u002Fm² (maximum dose not exceeding 3750 IU) is administered via intramuscular injection on Day 1 of each 21-day cycle for a total of 4 cycles.",[9],null,{"type":20,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Gemcitabine (GEM)","Gemcitabine 1000 mg\u002Fm² is given by intravenous infusion on Day 1 and Day 8 of each 21-day cycle for a total of 4 cycles.",[9],{"type":20,"name":30,"description":31,"armGroupLabels":32,"otherNames":24},"Oxaliplatin","Oxaliplatin 130 mg\u002Fm² is administered intravenously on Day 1 of each 21-day cycle for a total of 4 cycles.",[9],{"type":20,"name":34,"description":35,"armGroupLabels":36,"otherNames":24},"Selinexor","Following induction chemotherapy, patients will receive consolidation therapy consisting of selinexor combined with reduced-dose radiotherapy. Selinexor 40 mg will be administered orally twice weekly (Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Selinexor will be given concurrently with radiotherapy for a total of 8 doses.",[9],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":24},"RADIATION","radiotherapy","ollowing 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 expansion of 1-2 cm.",[9],[43],{"name":44,"affiliation":5,"role":45},"Liang Wang","PRINCIPAL_INVESTIGATOR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":24,"email":51},"Liang Wang, M.D.","CONTACT","+861058266633","wangliangtrhos@126.com",{"name":53,"role":49,"phone":54,"phoneExt":24,"email":55},"Jia Cong","+861058268442","congjia21@163.com",[57],{"facility":58,"status":24,"city":59,"state":24,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":24},"Beijing Tongren Hospital, Capital Medical University","Beijing","100730","China","CN",{"type":64,"coordinates":65},"Point",[66,67],116.39723,39.9075,{"lat":67,"lon":66},{"type":45,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"LIANG WANG","Director of Department of Hematology in Beijing Tongren Hospital","100635576","phase-2-selinexor-combined-with-reduced-dose-radiotherapy-for-early-stage-extranodal-nkt-cell-lymphoma-100635576",false,"NCT07554482","Selinexor Combined With Reduced-Dose Radiotherapy For Early-Stage Extranodal NK\u002FT-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\u002FT-Cell Lymphoma","Inclusion Criteria:\n\n* Aged 18 to 75 years, regardless of gender.\n* Pathologically confirmed extranodal NK\u002FT-cell lymphoma (ENKTCL).\n* Ann Arbor stage I-II disease with primary lesion located in the nasal cavity or upper aerodigestive tract (UADT).\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n* Treatment-naïve patients with no prior radiotherapy, chemotherapy or targeted therapy.\n* Adequate major organ function as follows:\n* Hematopoietic function: absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, platelet count (PLT) ≥100×10⁹\u002FL, hemoglobin (Hb) ≥90 g\u002FL.\n* Hepatic function: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), alanine transaminase (ALT) \u002F aspartate transaminase (AST) ≤2.5×ULN.\n* Renal function: serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance rate ≥60 mL\u002Fmin.\n* Cardiac function: left ventricular ejection fraction (LVEF) ≥50%.\n* Expected overall survival ≥6 months.\n* Voluntarily sign the written informed consent form.\n\nExclusion Criteria:\n\n* Non-nasal type ENKTCL, or primary lesions outside the upper aerodigestive tract (UADT), including skin, gastrointestinal tract, lung and other sites.\n* Patients with Ann Arbor stage III-IV disease.\n* Central nervous system involvement.\n* History of prior malignant tumors, excluding non-melanoma skin cancer or cervical carcinoma in situ cured for more than 5 years.\n* Active infections, including active hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) infection.\n* Severe complications, such as uncontrolled diabetes mellitus and severe cardiopulmonary diseases.\n* Pregnant or lactating women.\n* Hypersensitivity or contraindication to any investigational drugs in this study.\n* Concurrent participation in other interventional clinical trials.","ALL","18 Years","75 Years",{"count":83,"type":84},34,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","Extranodal NK\u002FT-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.",[90],"Extranodal NK\u002FT-cell Lymphoma",[92,93,94,39,95],"extranodal NK\u002FT-cell lymphoma","selinexor","XPO1 inhibitor","reduced-dose radiotherapy","NOT_YET_RECRUITING","2026-04-21",{"date":99,"type":100},"2026-04-28","ACTUAL",{"date":102,"type":84},"2026-05-15",{"date":104,"type":84},"2029-04-30",{"name":5,"class":6},1]