[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"complete-remission-rate-crr\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:complete-remission-rate-crr":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100634686","sintilimab-chidamide-and-azacitidine-for-untreated-stage-i-ii-extranodal-nkt-cell-lymphoma-100634686",false,"NCT07542912","Sintilimab, Chidamide, and Azacitidine for Untreated Stage I-II Extranodal NK\u002FT-Cell Lymphoma","A Single-Arm, Multicenter, Phase II Study of Sintilimab Combined With Chidamide and Azacitidine in Patients With Treatment-Naïve Stage I-II Extranodal Natural Killer\u002FT-Cell Lymphoma (SCENT-3)","SCENT-3","Inclusion Criteria:\n\n1. Willingness to participate in the clinical study.\n2. Age ≥ 18 years at the time of signing the Informed Consent Form (ICF).\n3. Newly diagnosed ENKTL confirmed by histopathology at the study center.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n5. At least one evaluable or measurable lesion\n6. Ann Arbor stage I-II disease.\n7. PINK-E score ≥ 1.\n8. Adequate organ and bone marrow function, with no severe hematopoietic dysfunction or abnormalities in cardiac, pulmonary, hepatic, renal, or thyroid function, and no immunodeficiency.\n\nExclusion Criteria:\n\n1. Aggressive natural killer cell leukemia.\n2. Presence of hemophagocytic syndrome.\n3. Primary central nervous system (CNS) lymphoma or secondary CNS involvement.\n4. Patients with a known history of human immunodeficiency virus (HIV) infection and\u002For acquired immunodeficiency syndrome (AIDS).\n5. Patients with active chronic hepatitis B or active hepatitis C.","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is an open-label, single-arm, multi-center Phase II clinical trial evaluating the efficacy and safety of a novel sequential regimen as first-line therapy for treatment-naïve patients with Extranodal NK\u002FT-cell Lymphoma (ENKTL). The study consists of a Screening Phase, a Safety Lead-in Phase, and a Treatment Phase. During the Safety Lead-in Phase, 6 patients will be enrolled to receive a fixed dose of Sintilimab and Chidamide combined with Azacitidine to verify the dose (testing 100mg\u002Fd on days 1-3 versus days 1-5). Following the lead-in, all subjects will undergo a 2-cycle Immunotherapy Induction Phase with the SCA regimen (Sintilimab, Chidamide, and Azacitidine). Subsequently, treatment will be stratified based on response: patients achieving Complete Response (CR) or Partial Response (PR) will receive 4 additional cycles of SCA consolidation, while those with Stable Disease (SD) or Progressive Disease (PD) will switch to 4 cycles of P-GemOx chemotherapy. Upon completion of systemic therapy, all patients will undergo consolidative involved-field radiotherapy (≥50Gy).",[27,28,29,30,31],"Complete Remission Rate， CRR","Progression Free Survival","Overall Survival","Adverse Event","Duration of Response",[33,34,35,36,37],"Extranodal NK\u002FT-cell Lymphoma","First-line Therapy","Sintilimab","Chidamide","Azacitidine","NOT_YET_RECRUITING","2026-04-17",{"date":41,"type":42},"2026-04-21","ACTUAL",{"date":44,"type":21},"2026-06-01",{"date":46,"type":21},"2029-06-01",{"name":48,"class":49},"Sun Yat-sen University","OTHER"]