[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638056":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":60,"collaborators":63,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":26,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Treatment Arm","ACTIVE_COMPARATOR","Patients in this arm will receive standard concurrent chemoradiotherapy (CCRT) with or without induction chemotherapy (IC). Following CCRT, all patients will receive standard adjuvant therapy, consisting of either a PD-1 inhibitor (administered intravenously every 3 weeks for up to 12 cycles) or metronomic capecitabine (650mg\u002Fm2 orally twice daily for one year), based on the investigator's discretion.",[13,14],"Drug: PD-1 inhibitor","Drug: Capecitabine",{"label":16,"type":17,"description":18,"interventionNames":19},"Experimental Arm: RAIRI-Guided","EXPERIMENTAL","Patients will receive standard CCRT with or without IC. After radiotherapy, patients are stratified using the Response-Adapted Individualized Risk Index (RAIRI) model. Patients identified as RAIRI Low-Risk (predicted 5-year PFS ≥ 85%) will be exempted from adjuvant therapy and undergo regular observation. Patients identified as RAIRI High-Risk (predicted 5-year PFS \\\u003C 85%) will receive adjuvant therapy (PD-1 inhibitor or capecitabine).",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","PD-1 inhibitor","Administered intravenously every 3 weeks for up to 12 cycles as adjuvant therapy.",[16,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Capecitabine","Metronomic capecitabine administered orally at a dose of 650 mg\u002Fm2 twice daily for one year as adjuvant therapy.",[16,9],[32],{"name":33,"affiliation":5,"role":34},"Junlin Yi, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Yang Liu, MD","CONTACT","+86 18801342502","530669421@163.com",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Beijing","Beijing Municipality","100021","China","CN",{"type":50,"coordinates":51},"Point",[52,53],116.39723,39.9075,{"lat":53,"lon":52},[56,59],{"name":33,"role":38,"phone":57,"phoneExt":26,"email":58},"+86-010-87788792","yijunlin1969@163.com",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Yi Junlin","Professor",[64,66,68,70,72,75,77,79,81],{"name":65,"class":6},"Fudan University",{"name":67,"class":6},"Peking University Cancer Hospital & Institute",{"name":69,"class":6},"Hunan Cancer Hospital",{"name":71,"class":6},"Sun Yat-Sen University Cancer Center",{"name":73,"class":74},"Fujian Cancer Hospital","OTHER_GOV",{"name":76,"class":6},"Xiangya Hospital of Central South University",{"name":78,"class":6},"Cancer Hospital of Guizhou Province",{"name":80,"class":6},"Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center",{"name":82,"class":6},"Xijing Hospital","100638056","phase-3-rairi-model-guided-adjuvant-therapy-in-nasopharyngeal-carcinoma-100638056",false,"NCT07590024","RAIRI Model-Guided Adjuvant Therapy in Nasopharyngeal Carcinoma","Individualized Adjuvant Therapy Decision-Making for Locoregionally Advanced Nasopharyngeal Carcinoma Guided by Response-Adapted Individualized Risk Index (RAIRI): A Multicenter, Randomized, Controlled Phase III Study","RAIRI-NPC","Inclusion Criteria\n\n1. Age 18-65 years, regardless of sex.\n2. Histologically confirmed EBER-positive, non-metastatic, non-keratinizing nasopharyngeal carcinoma.\n3. AJCC 9th edition stage II-III disease \u002F AJCC 8th edition stage III-IVA disease, excluding T3-T4N0 and T3N1 disease; or baseline EBV DNA \\>4,000 copies\u002FmL.\n4. Eastern Cooperative Oncology Group performance status score of 0-1.\n5. Availability of complete baseline pretreatment imaging data, including nasopharyngeal and neck MRI with functional MRI sequences, and at least one measurable tumor lesion.\n6. Availability of pretreatment baseline plasma cfEBV-DNA measurement.\n7. Patients must meet the following laboratory criteria: hemoglobin \\>120 g\u002FL and white blood cell count ≥4 × 10⁹\u002FL.\n8. Platelet count ≥100 × 10⁹\u002FL; liver and renal function parameters within 1.25 times the upper limit of normal; and no hearing impairment.\n9. Ability to understand the study and provision of written informed consent.\n10. Agreement to allow the use of personal data and biological samples, including blood and tissue samples, for research purposes.\n11. Adequate function of major organs, except for abnormalities related to nasopharyngeal carcinoma.\n12. Ability and willingness to comply with scheduled follow-up.\n\nExclusion Criteria\n\n1. Absence of pretreatment cfEBV-DNA data or other essential baseline characteristic data.\n2. AJCC 8th edition stage I-II or IVB disease \u002F AJCC 9th edition stage I or IV disease, or T3-4N0 or T3N1 disease.\n3. History of other malignancies, except stage I non-melanoma skin cancer or carcinoma in situ of the cervix.\n4. Pregnant or lactating women, or women of childbearing potential who are not using contraception.\n5. Current participation in another investigational drug trial.\n6. Severe comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, active ulcer disease, psychiatric illness, uncontrolled diabetes mellitus, active autoimmune disease, ongoing systemic immunosuppressive therapy, active infection requiring systemic treatment, history of human immunodeficiency virus infection, positive hepatitis B surface antigen, hepatitis B virus DNA \\>1 × 10³ copies\u002FmL or \\>200 IU\u002FmL, or positive hepatitis C virus antibody.\n7. Inability to comply with regular follow-up.","ALL","18 Years","65 Years",{"count":95,"type":96},651,"ESTIMATED","INTERVENTIONAL",[99],"PHASE3","This study aims to evaluate a personalized approach for treating patients with locoregionally advanced nasopharyngeal carcinoma (NPC). Currently, many high-risk patients receive additional treatment (adjuvant therapy) after standard chemoradiotherapy to prevent the cancer from returning. However, some patients may not actually need this extra treatment and could safely avoid its side effects.\n\nThis trial uses a novel risk prediction model called the Response-Adapted Individualized Risk Index (RAIRI). The RAIRI model evaluates how a patient's tumor and blood markers (such as Epstein-Barr Virus DNA) respond during and immediately after their initial chemoradiotherapy.\n\nIn this study, patients will be randomly assigned to one of two groups:\n\n1. Standard Treatment Group: All patients will receive standard adjuvant therapy (either a PD-1 inhibitor or capecitabine) after completing their initial chemoradiotherapy.\n2. RAIRI-Guided Group (Experimental): Patients will be evaluated using the RAIRI model after initial chemoradiotherapy. Only those identified as \"high-risk\" by the model will receive adjuvant therapy. Those identified as \"low-risk\" will be exempted from adjuvant therapy and will undergo regular observation.\n\nThe main goal of this study is to determine if using the RAIRI model to exempt low-risk patients from adjuvant therapy is as safe and effective as giving adjuvant therapy to everyone, measured by how long patients live without the disease returning or progressing.",[102],"Nasopharyngeal Carcinoma (NPC)",[104,105,106,107,108],"Adjuvant Therapy","RAIRI","EBV-DNA","Risk Stratification","response-adapted","2026-06-03",{"date":111,"type":112},"2026-06-04","ACTUAL",{"date":114,"type":112},"2026-05-01",{"date":116,"type":96},"2030-12-31",{"name":5,"class":6},1]