[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604788":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":35,"centralContacts":48,"locations":54,"responsibleParty":71,"collaborators":35,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":35,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":35,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":35,"overallStatus":57,"whyStopped":35,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,15,21,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Low risk arm 1","EXPERIMENTAL","Radiotherapy alone",[13,14],"Radiation: Radical radiotherapy of nasopharynx and neck","Drug: Toripalimab",{"label":16,"type":17,"description":18,"interventionNames":19},"Low risk arm 2","ACTIVE_COMPARATOR","Concurrent chemoradiotherapy",[13,20,14],"Drug: Concurrent chemoradiotherapy (cCRT)",{"label":22,"type":10,"description":23,"interventionNames":24},"High risk arm 1","Adjuvant capecitabine and immunotherapy after concurrent chemoradiotherapy",[13,25,20,14],"Drug: Capecitabine",{"label":27,"type":17,"description":28,"interventionNames":29},"High risk arm 2","Adjuvant immunotherapy after concurrent chemoradiotherapy",[13,20,14],[31,36,41,44],{"type":32,"name":33,"description":33,"armGroupLabels":34,"otherNames":35},"RADIATION","Radical radiotherapy of nasopharynx and neck",[22,27,9,16],null,{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":35},"DRUG","Capecitabine","Adjuvant metronomic capecitabine (650 mg\u002Fm² twice daily) for one year",[22],{"type":37,"name":42,"description":18,"armGroupLabels":43,"otherNames":35},"Concurrent chemoradiotherapy (cCRT)",[22,27,16],{"type":37,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"Toripalimab","Adjuvant Toripalimab (240mg day1, Q3W )",[22,27,9,16],[49],{"name":50,"role":51,"phone":52,"phoneExt":35,"email":53},"Ling-Long Tang","CONTACT","02087343840","tangll@sysucc.org.cn",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":64,"coordinates":65},"Point",[66,67],113.25,23.11667,{"lat":67,"lon":66},[70],{"name":50,"role":51,"phone":52,"phoneExt":35,"email":53},{"type":72,"investigatorFullName":50,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"PRINCIPAL_INVESTIGATOR","Prof.","100604788","phase-3-adaptive-immunotherapy-for-nasopharyngeal-carcinoma-100604788",false,"NCT07154069","Adaptive Immunotherapy for Nasopharyngeal Carcinoma","Adaptive Immunotherapy for Locoregional Nasopharyngeal Carcinoma: a Randomized, Controlled, Multicenter, Phase 3 Clinical Trial","Inclusion Criteria:\n\n* 18-65 years;\n* Newly diagnosed, pathologically confirmed non-keratinizing carcinoma (according to WHO criteria);\n* Locoregionally advanced nasopharyngeal carcinoma (Stage II-III) as defined by the 9th edition of the American Joint Committee on Cancer (AJCC) staging system;\n* ECOG performance status: 0-1;\n* Adequate bone marrow function: white blood cell count \\> 4 × 10⁹\u002FL, hemoglobin \\> 90 g\u002FL, platelet count \\> 100 × 10⁹\u002FL;\n* Normal renal and hepatic function: total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; creatinine clearance ≥ 60 mL\u002Fmin;\n* Normal thyroid function, amylase, lipase, pituitary function;\n* Completion of 3 cycles of GP regimen induction chemotherapy combined with PD-1 inhibitor immunotherapy;\n* Patients must provide signed informed consent and be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures;\n* Female participants of childbearing potential must agree to use reliable contraceptive methods (e.g., condoms, regular use of oral contraceptives as prescribed) from screening until one year after treatment.\n\nExclusion Criteria:\n\n* T3N0-1, according to the American Joint Committee on Cancer (AJCC) Staging System, 9th Edition;\n* Disease progression after induction therapy;\n* Hepatitis B surface antigen (HBsAg) positive with HBV DNA \\>1×10³ copies\u002FmL, or anti-hepatitis C virus (HCV) antibody positive;\n* Anti-HIV antibody positive or diagnosed with acquired immunodeficiency syndrome (AIDS);\n* Active tuberculosis;\n* Active, known, or suspected autoimmune disease. Exceptions include type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia);\n* History of interstitial lung disease or pneumonia requiring oral or intravenous steroid treatment within the past year;\n* Chronic systemic glucocorticoid therapy or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids are eligible;\n* Uncontrolled cardiac disease;\n* Pregnant or lactating women;\n* History or current diagnosis of another malignancy, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma;\n* Known allergy to macromolecular protein preparations or any component of toripalimab;\n* Active infection requiring systemic treatment within one week prior to enrollment;\n* Administration of a live vaccine within 30 days before the first dose of toripalimab;\n* History of organ transplantation;\n* Contraindications to MRI examination, which would prevent the completion of required imaging;\n* Any other condition deemed by the investigators to potentially compromise patient safety or compliance.","ALL","18 Years","65 Years",{"count":85,"type":86},802,"ESTIMATED","INTERVENTIONAL",[89],"PHASE3","1. To assess whether radiotherapy alone is non-inferior to concurrent chemoradiotherapy with respect to event-free survival and superior in reducing treatment-related nausea in low-risk locoregionally advanced nasopharyngeal carcinoma patients who achieve complete or partial response and undetectable serum EBV-DNA following induction chemoimmunotherapy.\n2. To evaluate whether adjuvant capecitabine and immunotherapy after concurrent chemoradiotherapy improves event-free survival compared to adjuvant immunotherapy in high-risk locoregionally advanced nasopharyngeal carcinoma patients with stable disease or detectable serum EBV-DNA after induction chemoimmunotherapy.",[92],"Nasopharyngeal Cancinoma (NPC)","2025-11-24",{"date":95,"type":96},"2025-11-25","ACTUAL",{"date":98,"type":96},"2025-11-13",{"date":100,"type":86},"2033-09",{"name":5,"class":6},1]