[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"duration-of-response\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:duration-of-response":49},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"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":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"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).",[26,27,28,29,30],"Complete Remission Rate， CRR","Progression Free Survival","Overall Survival","Adverse Event","Duration of Response",[32,33,34,35,36],"Extranodal NK\u002FT-cell Lymphoma","First-line Therapy","Sintilimab","Chidamide","Azacitidine","NOT_YET_RECRUITING","2026-04-17",{"date":40,"type":41},"2026-04-21","ACTUAL",{"date":43,"type":20},"2026-06-01",{"date":45,"type":20},"2029-06-01",{"name":47,"class":48},"Sun Yat-sen University","OTHER",""]