[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606583":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":26,"centralContacts":36,"locations":42,"responsibleParty":56,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":82,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental arm","EXPERIMENTAL","Radiotherapy",[13,14],"Radiation: Radiotherapy","Drug: Serplulimab",{"label":16,"type":17,"description":18,"interventionNames":19},"Control arm","ACTIVE_COMPARATOR","Cisplatin-based concurrent chemoradiotherapy (CCRT)",[13,14,20],"Drug: Cisplatin",[22,27,32],{"type":23,"name":11,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Following induction therapy, eligible patients will receive radiotherapy alone or concurrent chemoradiotherapy per protocol. Photon or proton radiotherapy techniques were permitted. Prescribed doses were:\n\nPrimary tumor and metastatic lymph nodes: 70 Gy\u002F33 fractions High-risk lymphatic drainage areas: 60 Gy\u002F33 fractions Low-risk regions: 54 Gy\u002F33 fractions\n\nPTV dose specifications:\n\nGTVnx: 70 Gy GTVnd: 66-70 Gy (reducible to 63 Gy for suspicious small nodes) CTV1: 60-62 Gy CTV2: 54-56 Gy All treatments will employ simultaneous integrated boost (SIB) intensity-modulated radiotherapy delivered once daily, 5 fractions per week.",[16,9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Serplulimab","Serplulimab will be used in the induction phase for 3 cycles and the maintenance phase for 14 cycles.",[16,9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"Cisplatin","On days 64 and 85, patients will receive cisplatin chemotherapy at a dose of 100 mg\u002Fm² via intravenous infusion.",[16],[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Chao Wan","CONTACT","+86 18062775069","wanc@hust.edu.cn",[43],{"facility":44,"status":26,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":26},"Wuhan Union Hospital","Wuhan","Hubei","430022","China","CN",{"type":51,"coordinates":52},"Point",[53,54],114.26667,30.58333,{"lat":54,"lon":53},{"type":57,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100606583","phase-3-serplulimab-combined-with-induction-chemotherapy-and-radiotherapy-in-nasopharyngeal-carcinoma-100606583",false,"NCT07177443","Serplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal Carcinoma","Induction Chemotherapy Combined With Serplulimab Induction\u002FMaintenance Therapy and Omission of Concurrent Chemotherapy in Locally Advanced Nasopharyngeal Carcinoma (UNION-NPC-001): A Multicenter, Open-Label, Randomized, Controlled, Phase III, Non-Inferiority Clinical Trial","Inclusion Criteria:\n\n1. Age at diagnosis: 18-65 years;\n2. Pathologically confirmed treatment-naïve nasopharyngeal carcinoma of \"non-keratinizing type (WHO classification)\";\n3. Locoregionally advanced nasopharyngeal carcinoma staged per the 9th edition of the American Joint Committee on Cancer (AJCC) staging system: Stage II (T1-3N2), Stage III(T1-4N3 or T4N1-2);\n4. ECOG performance status: 0-1;\n5. Post-induction therapy requirements:\n\n   Radiological assessment showing ≥50% tumor regression (RECIST 1.1) Undetectable plasma EBV DNA levels;\n6. Adequate bone marrow function:\n\n   White blood cell count \\>4×10⁹\u002FL Hemoglobin \\>90 g\u002FL Platelet count \\>100×10⁹\u002FL;\n7. Normal hepatic\u002Frenal function:\n\n   Total bilirubin ≤1.5×upper limit of normal (ULN) AST\u002FALT ≤2.5×ULN Alkaline phosphatase ≤2.5×ULN Creatinine clearance ≥60 mL\u002Fmin;\n8. Normal results for:\n\n   Thyroid function tests Amylase and lipase Pituitary function Inflammatory\u002Finfection markers Cardiac enzymes Electrocardiogram\n\n   Additional requirements:\n\n   Pulmonary function tests for smokers \\>50 years Cardiac ultrasound + myocardial function tests for patients with ECG abnormalities or cardiovascular history (unless meeting exclusion criterion (8));\n9. Signed informed consent with willingness\u002Fcompliance to follow study schedules for treatment, follow-up, and laboratory tests;\n10. For women of childbearing potential: Agreement to use reliable contraception (e.g., condoms, prescribed oral contraceptives) from screening until 1 year post-treatment.\n\nExclusion Criteria:\n\n1. Hepatitis B Virus (HBV) Infection:\n\n   HBsAg-positive with HBV DNA \\>1×10³ copies\u002FmL (patients with controlled viremia \\[\\\u003C1×10³ copies\u002FmL\\] after antiviral therapy are eligible).\n2. Hepatitis C Virus (HCV) Infection: Anti-HCV antibody-positive.\n3. HIV\u002FAIDS: Anti-HIV antibody-positive or diagnosed with acquired immunodeficiency syndrome (AIDS).\n4. Active Tuberculosis (TB): History of active TB within the past year (regardless of treatment status). Exception: Patients with adequately treated past TB (confirmed by standard anti-TB therapy) may be enrolled if \\>1 year since completion of treatment.\n5. Active Autoimmune Diseases:Known or suspected autoimmune disorders (e.g., uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, or asthma requiring bronchodilators).\n\n   Exceptions:\n\n   Type 1 diabetes mellitus Hypothyroidism managed with hormone replacement Skin conditions not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia).\n6. Interstitial Lung Disease (ILD):\n\n   History of ILD or pneumonitis requiring oral\u002FIV steroids within the past year.\n7. Immunosuppressive Therapy:\n\n   Chronic systemic corticosteroids (≥10 mg prednisone equivalent\u002Fday) or other immunosuppressants within 4 weeks prior to enrollment. Inhaled\u002Ftopical steroids are permitted.\n8. Uncontrolled Cardiac Disease: Heart failure (NYHA class ≥2), Unstable angina, Myocardial infarction within the past year, Clinically significant arrhythmias requiring treatment.\n9. Pregnancy\u002FLactation: Pregnant or breastfeeding women (urine\u002Fblood pregnancy test required for women of childbearing potential).\n10. Concurrent Malignancies:\n\n    History of other malignancies except:\n\n    Adequately treated non-melanoma skin cancer, Carcinoma in situ of the cervix, Papillary thyroid carcinoma.\n11. Hypersensitivity: Known allergy to any component of the study drugs or excipients.\n12. Active Infections:\n\n    Systemic infections requiring treatment within 1 week prior to enrollment.\n\n    Live Vaccines:\n13. Administration of live vaccines within 30 days before the first immunotherapy dose.\n14. Organ Transplantation: History of allogeneic organ transplantation.\n15. Other High-Risk Conditions:\n\nAny condition that may compromise patient safety or compliance per investigator assessment (e.g., severe psychiatric disorders, life-threatening comorbidities, or social\u002Ffamilial risk factors).","ALL","18 Years","65 Years",{"count":69,"type":70},456,"ESTIMATED","INTERVENTIONAL",[73],"PHASE3","This phase III trial aims to evaluate the efficacy and safety of induction chemotherapy combined with serplulimab (induction\u002Fmaintenance therapy) with omission of concurrent chemotherapy in patients with locally advanced nasopharyngeal carcinoma (LA-NPC).",[76],"Locally Advanced Nasopharyngeal Carcinoma",[78,79,80,81],"Cisplatin-based concurrent chemoradiotherapy","radiotherapy","Treatment De-escalation","locally advanced nasopharyngeal carcinoma","NOT_YET_RECRUITING","2025-09-16",{"date":85,"type":86},"2025-09-17","ACTUAL",{"date":88,"type":70},"2025-09-25",{"date":90,"type":70},"2031-12-31",{"name":5,"class":6},1]