[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638190":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":31,"studyPopulation":31,"armGroups":38,"interventions":48,"overallOfficials":31,"centralContacts":67,"locations":73,"responsibleParty":91,"collaborators":31,"id":94,"slug":31,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":31,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":31,"enrollmentInfo":102,"targetDuration":31,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":31,"overallStatus":111,"whyStopped":31,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Complete Response Rate (CRR)","The proportion of patients who achieve complete response at the end of radiotherapy, as assessed according to Lugano 2014 response criteria.","Up to approximately 6 months",[14,17,21,24,28],{"measure":15,"description":16,"timeFrame":12},"Overall Response Rate (ORR)","The proportion of patients who achieve complete response or partial response, as assessed according to Lugano 2014 response criteria.",{"measure":18,"description":19,"timeFrame":20},"Progression-Free Survival (PFS)","The time from enrollment to disease progression or death from any cause, whichever occurs first.","Up to 3 years",{"measure":22,"description":23,"timeFrame":20},"Overall Survival (OS)","The time from enrollment to death from any cause.",{"measure":25,"description":26,"timeFrame":27},"Incidence and severity of Adverse Events (AE) and Serious Adverse Event (SAE)","The incidence and severity of adverse events, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events.","Up to 30 days after the last study treatment",{"measure":29,"description":30,"timeFrame":20},"Change in Quality of Life","Quality of life will be assessed using the EORTC QLQ-C30 or FACT-G questionnaire.",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"NA","SINGLE_GROUP","TREATMENT",{"masking":37,"maskingDescription":31,"whoMasked":31},"NONE",[39],{"label":40,"type":41,"description":42,"interventionNames":43},"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.",[44,45,46,47],"Drug: Sintilimab","Drug: Pegaspargase","Drug: Selinexor","Radiation: radiotherapy",[49,54,58,62],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":31},"DRUG","Sintilimab","Sintilimab will be given at 200 mg by intravenous infusion.",[40],{"type":50,"name":55,"description":56,"armGroupLabels":57,"otherNames":31},"Pegaspargase","Pegaspargase will be given at 2000 U\u002Fm², with a maximum total dose of 3750 U, by intramuscular injection.",[40],{"type":50,"name":59,"description":60,"armGroupLabels":61,"otherNames":31},"Selinexor","Selinexor will be given orally once weekly at 60mg.",[40],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":31},"RADIATION","radiotherapy","Patients will receive induction treatment for up to 4 cycles, followed by radiotherapy.",[40],[68],{"name":69,"role":70,"phone":71,"phoneExt":31,"email":72},"Qingqing Cai","CONTACT","+8618353201165","caiqq@sysucc.org.cn",[74],{"facility":75,"status":31,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Sun Yat-sen University Cancer Center","Guangzhou","广东省 - Guangdong Sheng","510060","China","CN",{"type":82,"coordinates":83},"Point",[84,85],113.25,23.11667,{"lat":85,"lon":84},[88],{"name":69,"role":70,"phone":89,"phoneExt":31,"email":90},"18353201165","baisr@sysucc.org.cn",{"type":92,"investigatorFullName":69,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Professor and Chief Physician","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":103,"type":104},47,"ESTIMATED","INTERVENTIONAL",[107],"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).",[110],"NKTCL","NOT_YET_RECRUITING","2026-05-02",{"date":114,"type":115},"2026-05-08","ACTUAL",{"date":117,"type":104},"2026-05-06",{"date":119,"type":104},"2031-05-06",{"name":5,"class":6},1]