[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601443":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":61,"collaborators":22,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":22,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":88,"whyStopped":22,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Toripalimab group","EXPERIMENTAL","NPC Patients without cervical lymph node metastasis (N0 or N1 restricted to retropharyngeal lymph nodes) received two cycles of toripalimab, followed by cisplatin concurrent chemoradiotherapy without prophylactic neck irradiation, and adjuvant toripalimab up to 8 cycles.",[13,14,15],"Radiation: Without prophylactic neck irradiation","Drug: PD-1 antibody (Toripalimab)","Drug: Cisplatin",[17,23,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"RADIATION","Without prophylactic neck irradiation","Intensity-modulated radiotherapy restricted to the primary tumor, omitting prophylactic neck irradiation.",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"DRUG","PD-1 antibody (Toripalimab)","Toripalimab 240mg every 2 weeks with a total of 2 cycles as neoadjuvant anti-PD-1 immunotherapy; Toripalimab 240mg every 3 weeks with a total of 8 cycles as adjuvant anti-PD-1 immunotherapy after CCRT",[9],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":22},"Cisplatin","Cisplatin 100mg\u002Fm2(every three weeks), Day 1, Day 22, Day 43 of intensity modulated radiotherapy",[9],[33],{"name":34,"affiliation":35,"role":36},"Haiqiang Mai, MD,PhD","Sun Yat-sen Universitty Cancer Center","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":22,"email":42},"Qiuyan Chen, MD,PhD","CONTACT","86-20-87343380","chenqy@sysucc.org.cn",[44],{"facility":35,"status":22,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Guangzhou","Guangdong","510060","China","CN",{"type":51,"coordinates":52},"Point",[53,54],113.25,23.11667,{"lat":54,"lon":53},[57],{"name":58,"role":40,"phone":59,"phoneExt":22,"email":60},"Hai-Qiang Mai, MD,PhD","+862087343643","maihq@sysucc.org.cn",{"type":36,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Hai-Qiang Mai,MD,PhD","Professor","100601443","phase-2-radiotherapy-omitting-prophylactic-neck-irradiation-with-neoadjuvant-and-adjuvant-toripalimab-in-nasopharyngeal-carcinoma-100601443",false,"NCT07110558","Radiotherapy Omitting Prophylactic Neck Irradiation With Neoadjuvant and Adjuvant Toripalimab in Nasopharyngeal Carcinoma","A Single-arm, Phase II Trial of Radiotherapy Without Prophylactic Neck Irradiation in Combination With Neoadjuvant and Adjuvant Anti-PD-1 Antibody Toripalimab for Nasopharyngeal Carcinoma","PUPA","Inclusion Criteria:\n\n1. Age: 18 Years to 70 Years;\n2. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III\n3. Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1\n4. TNM stage based on AJCC 9th edition with N0-1 (retroperitoneal lymph nodes only), and either one following criteria:\n\n   1. T2 and primary gross tumor volume (GTV) greater than 30.0 cm3;\n   2. T3-4;\n5. Patients' lymph node without adverse features (no central necrosis, no muscle\u002Fskin invasion, no lymph node fusion).\n6. Male and no pregnant female\n7. Normal bone marrow function: white blood cell count \\> 4×10\\^9\u002FL, hemoglobin \\> 90g\u002FL, platelet count \\> 100×10\\^9\u002FL;\n8. Normal liver function: total bilirubin (TBIL) \\\u003C upper limit of normal (ULN), alanine transaminase (ALT) and aspartate transaminase (AST) \\\u003C 1.5 × ULN;\n9. Normal kidney function: creatinine clearance rate ≥ 60 ml\u002Fmin;\n10. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule;\n\nExclusion Criteria:\n\n1. Patients have evidence of relapse or distant metastasis\n2. Histologically confirmed keratinizing squamous cell carcinoma (WHO I)\n3. Patients with positive cervical lymph nodes\n4. Patients who have been treated with inhibitors of immune regulation (CTLA-4, PD-1, PD-L1, etc.).\n5. Receiving radiotherapy or chemotherapy previously\n6. Patients with active immunodeficiency disease and history of immunodeficiency disease\n7. Anti-human immunodeficiency virus (HIV) positive or diagnosed with acquired immune deficiency syndrome (AIDS)\n8. Chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg prednisone per day) or any other form of immunosuppressive therapy. Subjects who used inhaled or topical corticosteroids were eligible.\n9. Active tuberculosis: active tuberculosis in the past 1 year should be excluded regardless with treatment, history of active tuberculosis over 1 year should be excluded except that previous regulatory anti-tuberculosis treatment is proved.\n10. HBV DNA \\>2000 cps\u002Fml (or HBV DNA \\> 2000 IU\u002Fml); or HCV RNA \\>1000 cps\u002Fml; Hepatitis B surface antigen (HBsAg) positive and HCV antibody positive.\n11. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.\n12. Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.\n13. Uncontrolled heart disease, for example: 1) heart failure (NYHA level ≥ 2), 2) unstable angina, 3) myocardial infarction in past 1 year, 4) supraventricular or ventricular arrhythmia requiring treatment or intervention.\n14. Patients with significantly lower heart, liver, lung, kidney and bone marrow function.\n15. Severe, uncontrolled medical conditions and infections.\n16. At the same time using other test drugs or in other clinical trials.\n17. Refusal or inability to sign informed consent to participate in the trial.\n18. Other treatment contraindications.\n19. Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.","ALL","18 Years","70 Years",{"count":76,"type":77},59,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","This single-arm, phase 2 trial evaluates the efficacy and safety of de-escalated radiotherapy (restricted to the primary tumor, omitting prophylactic neck irradiation) combined with neoadjuvant and adjuvant toripalimab immunotherapy, and concurrent chemotherapy in patients with nasopharyngeal carcinoma staged N0 or N1, where nodal involvement is strictly confined to the retropharyngeal lymph nodes.",[83],"Nasopharyngeal Cancinoma (NPC)",[85,86,87],"nasopharyngeal carcinoma","radiotherapy","immunotherapy","NOT_YET_RECRUITING","2025-07-31",{"date":91,"type":92},"2025-08-07","ACTUAL",{"date":94,"type":77},"2025-08-15",{"date":96,"type":77},"2032-08-14",{"name":5,"class":6},1]