[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638190":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":37,"locations":43,"responsibleParty":61,"collaborators":23,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":23,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":23,"enrollmentInfo":73,"targetDuration":23,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":23,"overallStatus":82,"whyStopped":23,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sintilimab, pegaspargase, and selinexor","EXPERIMENTAL","Patients will receive induction therapy with sintilimab, pegaspargase, and selinexor every 21 days for up to 4 cycles, followed by radiotherapy.",[13,14,15,16],"Drug: Sintilimab","Drug: Pegaspargase","Drug: Selinexor","Radiation: radiotherapy",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Sintilimab","Sintilimab will be given at 200 mg by intravenous infusion.",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Pegaspargase","Pegaspargase will be given at 2000 U\u002Fm², with a maximum total dose of 3750 U, by intramuscular injection.",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"Selinexor","Selinexor will be given orally once weekly at 60mg.",[9],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":23},"RADIATION","radiotherapy","Patients will receive induction treatment for up to 4 cycles, followed by radiotherapy.",[9],[38],{"name":39,"role":40,"phone":41,"phoneExt":23,"email":42},"Qingqing Cai","CONTACT","+8618353201165","caiqq@sysucc.org.cn",[44],{"facility":45,"status":23,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Sun Yat-sen University Cancer Center","Guangzhou","广东省 - Guangdong Sheng","510060","China","CN",{"type":52,"coordinates":53},"Point",[54,55],113.25,23.11667,{"lat":55,"lon":54},[58],{"name":39,"role":40,"phone":59,"phoneExt":23,"email":60},"18353201165","baisr@sysucc.org.cn",{"type":62,"investigatorFullName":39,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Professor and Chief Physician","100638190","phase-2-a-phase-ii-study-of-sintilimab-pegaspargase-and-selinexor-followed-by-radiotherapy-in-newly-diagnosed-stage-iii-extranodal-nkt-cell-lymphoma-100638190",false,"NCT07574528","A Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I\u002FII Extranodal NK\u002FT-Cell Lymphoma","A Multicenter, Single-Arm, Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I\u002FII Extranodal NK\u002FT-Cell Lymphoma","Inclusion Criteria:\n\n* Age 18 years or older.\n* No prior systemic treatment for lymphoma, except short-term corticosteroids for symptom control.\n* Life expectancy of more than 3 months.\n* Eastern Cooperative Oncology Group performance status of 0 to 2.\n* Histologically confirmed extranodal natural killer\u002FT-cell lymphoma.\n* Primary lesion located in the nasal cavity or upper aerodigestive tract.\n* Stage I to II disease.\n* At least one measurable or evaluable lesion according to Lugano 2014 criteria.\n* Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n* Aggressive NK-cell leukemia.\n* Significant dysfunction of major organs.\n* Known hypersensitivity to any study drug or its components, or contraindication to any study treatment.\n* Pregnant or breastfeeding women, or participants of childbearing potential unwilling to use effective contraception.\n* Known history of human immunodeficiency virus infection or acquired immunodeficiency syndrome.","ALL","18 Years",{"count":74,"type":75},47,"ESTIMATED","INTERVENTIONAL",[78],"PHASE2","This is a single-arm, open-label, multicenter phase II study evaluating sintilimab, pegaspargase, and selinexor followed by radiotherapy as first-line treatment for patients with newly diagnosed stage I\u002FII extranodal natural killer\u002FT-cell lymphoma (ENKTL).",[81],"NKTCL","NOT_YET_RECRUITING","2026-05-02",{"date":85,"type":86},"2026-05-08","ACTUAL",{"date":88,"type":75},"2026-05-06",{"date":90,"type":75},"2031-05-06",{"name":5,"class":6},1]