[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651068":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":42,"locations":52,"responsibleParty":70,"collaborators":72,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":28,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":28,"enrollmentInfo":86,"targetDuration":28,"studyType":89,"phases":90,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":102,"whyStopped":28,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Tianjin Medical University Second Hospital","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Disitamab Vedotin Plus Toripalimab With Pelvic Lymph Node Dissection","EXPERIMENTAL","Participants will receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab and standardized pelvic lymph node dissection.",[13,14,15,16],"Drug: Disitamab Vedotin (RC48)","Drug: Toripalimab","Procedure: Transurethral Resection of Bladder Tumor","Procedure: Pelvic Lymph Node Dissection",{"label":18,"type":19,"description":20,"interventionNames":21},"Disitamab Vedotin Plus Toripalimab Without Pelvic Lymph Node Dissection","ACTIVE_COMPARATOR","Participants will receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab without planned pelvic lymph node dissection.",[13,14,15],[23,29,33,38],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Disitamab Vedotin (RC48)","Disitamab vedotin will be administered in combination with toripalimab according to the study protocol.",[9,18],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Toripalimab","Toripalimab will be administered in combination with disitamab vedotin according to the study protocol.",[9,18],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"PROCEDURE","Transurethral Resection of Bladder Tumor","Maximal transurethral resection of bladder tumor will be performed as part of the bladder-sparing treatment strategy.",[9,18],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"Pelvic Lymph Node Dissection","Standardized pelvic lymph node dissection will be performed in participants assigned to the PLND arm.",[9],[43,48],{"name":44,"role":45,"phone":46,"phoneExt":28,"email":47},"Hailong Hu","CONTACT","+86 13662096232","huhailong@tmu.edu.cn",{"name":49,"role":45,"phone":50,"phoneExt":28,"email":51},"Peng Li","+86 18935803489","lipeng990220@tmu.edu.cn",[53],{"facility":54,"status":28,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"The Second Hospital of Tianjin Medical University","Tianjin","Tianjin Municipality","300211","China","CN",{"type":61,"coordinates":62},"Point",[63,64],117.17667,39.14222,{"lat":64,"lon":63},[67,69],{"name":68,"role":45,"phone":46,"phoneExt":28,"email":47},"Hailong Hu, MD,PhD",{"name":49,"role":45,"phone":50,"phoneExt":28,"email":51},{"type":71,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[73,75],{"name":74,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"name":76,"class":6},"The First Affiliated Hospital with Nanjing Medical University","100651068","bladder-sparing-treatment-with-disitamab-vedotin-and-toripalimab-with-or-without-pelvic-lymph-node-dissection-in-bladder-cancer-100651068",false,"NCT07756008","Bladder-Sparing Treatment With Disitamab Vedotin and Toripalimab With or Without Pelvic Lymph Node Dissection in Bladder Cancer","A Prospective, Multicenter, Randomized Controlled Study of Disitamab Vedotin Plus Toripalimab With or Without Pelvic Lymph Node Dissection for Bladder-Sparing Treatment in Patients With cT2-3N0M0 Bladder Urothelial Carcinoma","Inclusion Criteria:\n\n1. Male or female participants aged 18 years or older.\n2. Histologically confirmed bladder urothelial carcinoma.\n3. Clinical stage cT2-3N0M0 according to the AJCC 8th edition TNM staging system.\n4. HER2 expression of IHC 2+ or higher.\n5. Participants who decline radical cystectomy as assessed by the investigator.\n6. Adequate organ function as defined in the study protocol.\n7. Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to disitamab vedotin, toripalimab, their excipients, or other monoclonal antibodies.\n2. Prior radiotherapy for bladder cancer.\n3. Prior anticancer treatment that may affect efficacy assessment, as defined in the study protocol.\n4. Pregnant or breastfeeding women.\n5. Any serious uncontrolled disease or medical condition that, in the investigator's judgment, would make participation inappropriate.\n6. Participation in another interventional clinical trial that may interfere with this study.","ALL","18 Years",{"count":87,"type":88},114,"ESTIMATED","INTERVENTIONAL",[91,92],"PHASE2","PHASE3","This is a prospective, multicenter, randomized controlled superiority study designed to evaluate whether the addition of pelvic lymph node dissection improves bladder-intact event-free survival in patients with cT2-3N0M0 bladder urothelial carcinoma receiving bladder-sparing treatment. Eligible patients with HER2 expression of IHC 2+ or higher who decline radical cystectomy will be randomized 1:1 to receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab with or without standardized pelvic lymph node dissection. The primary endpoint is the 2-year bladder-intact event-free survival rate. Secondary endpoints include clinical complete response, partial response, disease progression, overall survival, quality of life, safety, treatment cost, and exploratory biomarker analyses.",[95,96,97],"Bladder Urothelial Carcinoma","Muscle-invasive Bladder Cancer","Bladder Cancer",[99,100,30,101],"Bladder-sparing therapy","Disitamab vedotin","Pelvic lymph node dissection","NOT_YET_RECRUITING","2026-08-04",{"date":105,"type":106},"2026-08-10","ACTUAL",{"date":108,"type":88},"2026-08-01",{"date":110,"type":88},"2031-06-20",{"name":5,"class":6},1]