[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634686":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":38,"collaborators":19,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":19,"enrollmentInfo":52,"targetDuration":19,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":71,"whyStopped":19,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: SCA Induction followed by Response-Adapted Therapy","EXPERIMENTAL","Drug: Sintilimab, Chidamide, and Azacitidine (SCA Regimen) Safety Lead-in: Patients receive Sintilimab (fixed dose) and Chidamide (fixed dose) combined with Azacitidine at two dose levels (100mg\u002Fd on days 1-3 vs. days 1-5) to verify the combination dose.\n\nInduction Phase: All enrolled patients receive 2 cycles of SCA induction: Sintilimab (200mg, D1), Chidamide (30mg, biw, D1-21), and Azacitidine (100mg, D1-3\u002F5 \\[SCA\\]). Cycle length is 21 days.\n\nResponse-Adapted Consolidation:\n\nPatients achieving Complete Response (CR) or Partial Response (PR) continue with 4 cycles of the SCA regimen.\n\nPatients with Stable Disease (SD) or Progressive Disease (PD) switch to 4 cycles of P-GemOx chemotherapy (Pemetrexed + Gemcitabine + Oxaliplatin).\n\nRadiation: Involved-Field Radiotherapy (IFRT) Following the completion of immunotherapy or chemotherapy, all patients receive local radiotherapy (≥50Gy).",[13],"Drug: SCA Induction followed by Response-Adapted Therapy",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","SCA Induction followed by Response-Adapted Therapy",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Huiqiang Huang, Ph.D.","CONTACT","020-87343009","huanghq@sysucc.org.cn",[27],{"facility":28,"status":19,"city":29,"state":19,"zip":19,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":19},"Sun Yat-sen University Cancer Center","Guangzhou","China","CN",{"type":33,"coordinates":34},"Point",[35,36],113.25,23.11667,{"lat":36,"lon":35},{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Huiqiang Huang","Professor","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":53,"type":54},30,"ESTIMATED","INTERVENTIONAL",[57],"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).",[60,61,62,63,64],"Complete Remission Rate， CRR","Progression Free Survival","Overall Survival","Adverse Event","Duration of Response",[66,67,68,69,70],"Extranodal NK\u002FT-cell Lymphoma","First-line Therapy","Sintilimab","Chidamide","Azacitidine","NOT_YET_RECRUITING","2026-04-17",{"date":74,"type":75},"2026-04-21","ACTUAL",{"date":77,"type":54},"2026-06-01",{"date":79,"type":54},"2029-06-01",{"name":5,"class":6},1]