[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616259":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":45,"collaborators":49,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":18,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":18,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":104,"whyStopped":18,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Guangxi Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Adjuvant Becotatug Vedotin","EXPERIMENTAL","Adjuvant therapy with Becotatug Vedotin",[13],"Drug: Becotatug Vedotin",{"label":15,"type":16,"description":17,"interventionNames":18},"observation","NO_INTERVENTION","Clinical follow-up and surveillance only",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Becotatug Vedotin","This group will receive Becotatug Vedotin at a dose of 2.3 mg\u002Fkg on day 1 of each 3-week cycle for a total of 3 cycles.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"kai hu","CONTACT","+867715359801","hukai@gxmu.edu.cn",[32],{"facility":33,"status":18,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":18},"The First Affiliated Hospital of Guangxi Medical University","Nanning","Guangxi","530021","China","CN",{"type":40,"coordinates":41},"Point",[42,43],108.31667,22.81667,{"lat":43,"lon":42},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Kai Hu","professor",[50,52,54,56,58,60,63,65,67,69,71,74,76,78],{"name":51,"class":6},"Wuzhou Red Cross Hospital",{"name":53,"class":6},"First People's Hospital of Yulin",{"name":55,"class":6},"Guigang People's Hospital",{"name":57,"class":6},"Hainan Cancer Hospital",{"name":59,"class":6},"Affiliated Hospital of North Sichuan Medical College",{"name":61,"class":62},"Lingshan people's Hospital","UNKNOWN",{"name":64,"class":6},"LiuZhou People's Hospital",{"name":66,"class":62},"The Third people's hospital of Hechi",{"name":68,"class":62},"the second People's Hospital of qinzhou",{"name":70,"class":6},"Hunan Cancer Hospital",{"name":72,"class":73},"Fujian Cancer Hospital","OTHER_GOV",{"name":75,"class":62},"Guangxi Nanxishan Hospital",{"name":77,"class":73},"Liuzhou Workers' Hospital",{"name":79,"class":62},"Affiliated Hospital of Youjiang Medical University for Nationalitie","100616259","phase-2-becotatug-vedotin-as-adjuvant-therapy-for-high-risk-nasopharyngeal-carcinoma-100616259",false,"NCT07303283","Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma","Single-agent Becotatug Vedotin as Adjuvant Therapy for High-risk Locoregional Advanced Nasopharyngeal Carcinoma: a Multicentre, Open-label, Parallel-group, Randomised, Controlled, Phase 2 Trial","Inclusion Criteria:\n\n1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II\u002FIII).\n2. Eligible patients with high-risk locoregionally advanced NPC, defined as AJCC (9th edition) stage T4N1M0 or Tany N2-3M0 disease, or persistent high-risk features after induction chemotherapy (SD, PD, or detectable plasma EBV DNA).\n3. ECOG performance status ≤1.\n4. Induction and concurrent chemoradiotherapy with the recommended regimen have been completed.\n5. No later than 6 weeks after the completion of the last radiotherapy treatment.\n6. Adequate hematologic (neutrophil count \\> 1.5×10\\^9\u002FL, hemoglobin \\> 90g\u002FL and platelet count \\> 100×10\\^9\u002FL), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase \\\u003C 2.5×ULN) and renal function (creatinine clearance \\> 50 ml\u002Fmin)\n7. Patients must be informed of the investigational nature of this study and give written informed consent.\n8. Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Patients who could not tolerate or were allergic to Becotatug Vedotin.\n2. Patients with severe chronic or active infection that must be treated with systemic antibacterial, antifungal, or antiviral therapy before randomization, including but not limited to tuberculosis infection.\n3. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.\n4. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).\n5. Interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy within 1 year.\n6. Patients who are known to be intolerant or sensitive to any therapeutic agents.\n7. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \\> 1.5×ULN), and emotional disturbance.","ALL","18 Years","65 Years",{"count":91,"type":92},140,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","This is a phase 2, multicentre, open-label, randomised, controlled trial with a parallel-group design. The study aims to evaluate the efficacy and safety of single-agent Becotatug Vedotin as adjuvant therapy in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (NPC).",[98,99,100],"Nasopharyngeal Carcinoma (NPC)","Locoregionally Advanced Nasopharyngeal Carcinoma","Adjuvant Therapy",[102,103,22],"Nasopharyngeal Carcinoma","Adjuvant therapy","NOT_YET_RECRUITING","2026-06-06",{"date":107,"type":108},"2026-06-09","ACTUAL",{"date":110,"type":92},"2026-09-01",{"date":112,"type":92},"2033-08-31",{"name":47,"class":6},1]