[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579483":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":45,"collaborators":20,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":20,"overallStatus":29,"whyStopped":20,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"P-P-GemOx arm","EXPERIMENTAL","Sintilimab, pegaspargase combined with gemcitabine and oxaliplatin (P-P-GEMOX) regimen",[13],"Drug: Immunochemotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Immunochemotherapy","P-P-GemOx regimen Sintilimab 200mg iv D1; Pegaspargase 3750U im D1; GemOx regimen: Gemcitabine 1000mg\u002Fm2 iv D1, Oxaliplatin 100mg\u002Fm2 iv D1 This regimen is administered every 3 weeks.\n\nFor patients with stage I-II (localized) disease:\n\nA sandwich approach incorporating radiotherapy is employed. Patients initially receive 2 cycles of the P-P-GemOx regimen. If the interim evaluation demonstrates a complete response (CR) or partial response (PR), patients will proceed to intensity-modulated radiotherapy (IMRT). Following radiotherapy, an additional 2 cycles of the P-P-GemOx regimen are administered.\n\nFor patients with stage III-IV (advanced) disease. Patients are planned to receive 6 cycles of the P-P-GemOx regimen. For those achieving CR or PR following 6 cycles of immunochemotherapy, subsequent treatment options include autologous hematopoietic stem cell transplantation (auto-HSCT) or PD-1 monoclonal antibody maintenance therapy, determined based on age and overall physical condition.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Wei Zhang","CONTACT","010-69155760","vv1223@vip.sina.com",[28],{"facility":5,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"RECRUITING","Beijing","Beijing Municipality","100730","China","CN",{"type":36,"coordinates":37},"Point",[38,39],116.39723,39.9075,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":25,"phoneExt":20,"email":44},"Chong Wei, Doctor","QH5035@163.com",{"type":46,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100579483","phase-2-sintilimab-pegaspargase-plus-gemox-for-untreated-extranodal-nkt-cell-lymphoma-100579483",false,"NCT06824883","Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK\u002FT-Cell Lymphoma","A Single-arm, Phase 2 Study of Sintilimab, Pegaspargase Combined with Gemcitabine and Oxaliplatin (P-P-GEMOX) Regimen for Newly Diagnosed Extranodal NK\u002FT-Cell Lymphoma","Inclusion Criteria:\n\n* Histopathologically confirmed diagnosis of extranodal NK\u002FT-cell lymphoma (ENKTL) by the study center.\n* Age between 18 and 75 years.\n* At least one of the following risk factors: Age ≥ 60 years; Presence of B symptoms; ECOG performance status ≥ 2; Elevated lactate dehydrogenase (LDH); Baseline EBV-DNA \\> 500 copies\u002FmL.\n* ECOG performance status of 0 to 3.\n* Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL (≥ 1.0 × 10⁹\u002FL in cases with bone marrow involvement); Platelet count (PLT) ≥ 80 × 10⁹\u002FL (≥ 50 × 10⁹\u002FL in cases with bone marrow involvement); Hemoglobin (HGB) ≥ 80 g\u002FL.\n* Adequate organ function: Alanine aminotransferase (ALT) \\\u003C 3 × the upper limit of normal (ULN); Total bilirubin (TBil) \\\u003C 1.5 × ULN; Serum creatinine \\\u003C 1.5 × ULN; NYHA heart function class 0-2; Left ventricular ejection fraction (LVEF) \\> 50%.\n\nExclusion Criteria:\n\n* Aggressive NK-cell leukemia.\n* Central nervous system lymphoma.\n* History of any of the following within 6 months: Acute myocardial infarction; Unstable angina; Congestive heart failure; Uncontrolled symptomatic arrhythmia; Complete left bundle branch block; Second- or third-degree atrioventricular block; Long QT syndrome or corrected QT interval (QTc) \\> 480 ms.\n* Uncontrolled active infection.\n* Pregnant or breastfeeding women.","ALL","18 Years","75 Years",{"count":58,"type":59},49,"ESTIMATED","INTERVENTIONAL",[62],"PHASE2","This is a single-arm phase 2 study designed to evaluate the safety and efficacy of sintilimab, pegaspargase combined with gemcitabine and oxaliplatin (P-P-GEMOX regimen) as first-line treatment for patients with ENKTL. The primary endpoint is the complete response rate (CRR) in the intention-to-treat population.The secondary endpoints were overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse events.",[65],"Extranodal NK\u002FT-cell Lymphoma","2025-02-08",{"date":68,"type":69},"2025-02-13","ACTUAL",{"date":71,"type":69},"2024-05-20",{"date":73,"type":59},"2027-05-20",{"name":5,"class":6},1]