[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631302":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":42,"locations":51,"responsibleParty":67,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":28,"enrollmentInfo":83,"targetDuration":28,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":99,"whyStopped":28,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Disitamab Vedotin Plus Radiotherapy","EXPERIMENTAL","Participants in this arm will receive disitamab vedotin plus radiotherapy as adjuvant treatment after radical surgery for HER2-expressing,cisplatin-ineligible upper tract urothelial carcinoma.",[13,14],"Drug: Disitamab Vedotin (RC48)","Radiation: radiotherapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Gemcitabine Plus Carboplatin","ACTIVE_COMPARATOR","Participants in this arm will receive gemcitabine plus carboplatin as adjuvant treatment after radical surgery for HER2-expressing cisplatin-ineligible upper tract urothelial carcinoma.",[20,21],"Drug: Gemcitabine (1000 mg\u002Fm2)","Drug: carboplatin",[23,29,34,38],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Disitamab Vedotin (RC48)","Disitamab vedotin 2.0 mg\u002Fkg (maximum 120 mg) will be administered intravenously every 2 weeks for 12 cycles as adjuvant treatment after radical surgery.",[9],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"RADIATION","radiotherapy","Adjuvant radiotherapy will be delivered to the regional lymphatic drainage area at 45-50 Gy in 25 fractions over 5 weeks. Suspicious lymph nodes will receive 62.5 Gy in 25 fractions over 5 weeks.",[9],{"type":24,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"Gemcitabine (1000 mg\u002Fm2)","Gemcitabine 1000 mg\u002Fm² will be administered on Days 1 and 8 of each 21-day cycle for 4 to 6 cycles as adjuvant treatment after radical surgery.",[16],{"type":24,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"carboplatin","Carboplatin will be administered intravenously on Day 1 of each 21-day cycle at a target AUC of 4.5 to 5 for 4 to 6 cycles as adjuvant treatment after radical surgery.",[16],[43,48],{"name":44,"role":45,"phone":46,"phoneExt":28,"email":47},"Xuesong Li, Dr.","CONTACT","010-83572418","pineneedle@sina.com",{"name":49,"role":45,"phone":28,"phoneExt":28,"email":50},"Zihao Tao, Dr.","taozihao@pku.edu.cn",[52],{"facility":5,"status":28,"city":53,"state":28,"zip":28,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Beijing","China","CN",{"type":57,"coordinates":58},"Point",[59,60],116.39723,39.9075,{"lat":60,"lon":59},[63,64],{"name":44,"role":45,"phone":46,"phoneExt":28,"email":47},{"name":65,"role":45,"phone":28,"phoneExt":28,"email":66},"Qi Tang, Dr.","drtangq@bjmu.edu.cn",{"type":68,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[70],{"name":71,"class":72},"RemeGen Co., Ltd.","INDUSTRY","100631302","phase-2-disitamab-vedotin-plus-radiotherapy-for-adjuvant-treatment-of-her2-expressing-cisplatin-ineligible-upper-tract-urothelial-carcinoma-100631302",false,"NCT07498907","Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma","A Randomized, Prospective, Multicenter, Phase II Study of Disitamab Vedotin Plus Radiotherapy as Adjuvant Treatment for HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma","LUXUS41","Inclusion Criteria:\n\n* Aged 18 years or older.\n* Histologically confirmed upper tract urothelial carcinoma (UTUC) after radical nephroureterectomy (RNU).\n* Postoperative pathologic stage pT3-pT4N0M0 or pTanyN+M0.\n* HER2 expression confirmed by immunohistochemistry (IHC 1+, 2+, or 3+).\n* Cisplatin-ineligible, defined as meeting at least one of the following criteria: ECOG performance status 2; creatinine clearance \\\u003C60 mL\u002Fmin; CTCAE grade 2 or higher hearing loss; CTCAE grade 2 or higher peripheral neuropathy; or New York Heart Association (NYHA) class III heart failure.\n* Adequate organ function.\n* Expected survival of at least 6 months.\n\nExclusion Criteria:\n\n* History of other active malignancies, except for adequately treated malignancies with low risk of recurrence.\n* Prior systemic antitumor therapy before study treatment, or unresolved toxicities from prior therapy.\n* Known hypersensitivity to disitamab vedotin, related agents, or any component of the study treatment.\n* Severe active infection.\n* Not adequately recovered from surgery.\n* Pregnant or breastfeeding women.\n* Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.","ALL","18 Years",{"count":84,"type":85},192,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","This randomized, open-label, multicenter phase II study is designed to compare disitamab vedotin plus radiotherapy with gemcitabine plus carboplatin as adjuvant treatment in patients with HER2-expressing upper tract urothelial carcinoma after radical nephroureterectomy (RNU). Eligible patients must have postoperative pathologic stage pT3-pT4N0M0 or pTanyN+M0, HER2 expression defined as immunohistochemistry (IHC) 1+, 2+, or 3+, and be cisplatin-ineligible. Patients will be randomized in a 2:1 ratio to receive disitamab vedotin plus radiotherapy or gemcitabine plus carboplatin. The primary endpoint is 3-year disease-free survival. Secondary endpoints include overall survival, metastasis-free survival, local recurrence-free survival, bladder recurrence-free survival, incidence of adverse events, and patient-reported quality of life.",[91],"Upper Tract Urothelial Carcinoma",[93,94,95,96,97,98,91],"UTUC","HER2","Disitamab Vedotin","Radiotherapy","Adjuvant Therapy","Cisplatin-Ineligible","NOT_YET_RECRUITING","2026-03-23",{"date":102,"type":103},"2026-03-27","ACTUAL",{"date":105,"type":85},"2026-05-01",{"date":107,"type":85},"2034-03-01",{"name":5,"class":6},1]