[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638386":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":45,"collaborators":47,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":20,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":78,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant disitamab vedotin + tislelizumab followed by response-adapted surgery","EXPERIMENTAL","Drug: Disitamab Vedotin Administered intravenously at 2.0 mg\u002Fkg every 3 weeks\n\nDrug: Tislelizumab Administered intravenously at 200 mg every 3 weeks\n\nProcedure: Surgery Kidney-sparing surgery (segmental ureterectomy or endoscopic ablation) or radical nephroureterectomy based on predefined criteria",[13],"Drug: RC48 Combined With Tislelizumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","RC48 Combined With Tislelizumab","In this trial, RC48 was scheduled to be administered at a dose of 2.0 mg\u002Fkg every 3 weeks, with the first dose on day 1 of the first cycle. Tislelizumab was administered at a dose of 200 mg every 3 weeks, with the first dose on day 1 of the first 21-day cycle. The drug is diluted with normal saline and administered by intravenous drip for one hour.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"jiwei huang","CONTACT","8613651682825","huangjiwei@renji.com",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":20,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Ethics Committee of Shanghai Renji Hospital","Shanghai","Shanghai Municipality","China","CN",{"type":35,"coordinates":36},"Point",[37,38],121.45806,31.22222,{"lat":38,"lon":37},[41],{"name":42,"role":24,"phone":43,"phoneExt":20,"email":44},"Qi Lu","+86021-68383364","rjllb3364@163.com",{"type":46,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[48,50,52],{"name":49,"class":6},"West China Hospital",{"name":51,"class":6},"Tianjin Medical University Second Hospital",{"name":53,"class":6},"Peking University First Hospital","100638386","phase-2-biomarker-enriched-kidney-preserving-strategy-with-disitamab-vedotin-plus-tislelizumab-in-her2-positive-high-risk-upper-tract-urothelial-carcinoma-100638386",false,"NCT07584733","Biomarker-Enriched Kidney-Preserving Strategy With Disitamab Vedotin Plus Tislelizumab in HER2-Positive High-Risk Upper Tract Urothelial Carcinoma","A Prospective, Multicentre, Single-Arm Phase II Study Evaluating a Response-Adapted Kidney-Preserving Strategy Using Neoadjuvant Disitamab Vedotin Plus Tislelizumab in Patients With HER2-Positive High-Risk Upper Tract Urothelial Carcinoma (DISTINCT-II)","Inclusion Criteria:\n\n* Age ≥18 years at the time of informed consent.\n* Histologically confirmed upper tract urothelial carcinoma (UTUC) arising from the renal pelvis or ureter, based on ureteroscopic biopsy.\n* High-risk UTUC, defined by at least one of the following features: Tumour size ≥2 cm; High-grade cytology or biopsy; Radiographic evidence of local invasion (≥cT2); Hydronephrosis; Multifocal disease\n* Clinical stage cT1-T3, N0-N1, M0, based on radiographic assessment.\n* N1 disease is permitted only if lymph nodes are considered resectable.\n* HER2-positive disease, defined as immunohistochemistry (IHC) score of 1+，2+ or 3+ on tumour tissue, assessed according to predefined criteria.\n* At least one measurable lesion according to RECIST version 1.1.\n* ECOG performance status of 0-1\n* Adequate organ function, including: Hematologic function; Hepatic function; Renal function (no strict upper\u002Flower limit required);\n* Patients must be considered potential candidates for a kidney-preserving treatment strategy, including: Absolute or relative indication for renal preservation (e.g., solitary kidney, baseline renal insufficiency), or Strong preference for kidney preservation after multidisciplinary discussion\n* Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* Evidence of distant metastatic disease (M1).\n* Unresectable or bulky nodal disease (≥N2) not amenable to curative-intent surgery.\n* Prior systemic therapy for urothelial carcinoma, including:Chemotherapy; Immunotherapy; HER2-targeted therapy.\n* Prior radical nephroureterectomy for current disease.\n* Active autoimmune disease requiring systemic treatment within the past 2 years.\n* Current use of immunosuppressive medication, excluding physiologic doses of corticosteroids.\n* Uncontrolled intercurrent illness, including but not limited to: Active infection requiring systemic therapy; Uncontrolled cardiovascular disease; Significant pulmonary disease\n* Known active hepatitis B, hepatitis C, or HIV infection with uncontrolled viral replication.\n* History of another malignancy within the past 5 years, except: Adequately treated basal cell carcinoma; Squamous cell skin cancer; In situ carcinoma.\n* Pregnant or breastfeeding women.\n* Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results.","ALL","18 Years","85 Years",{"count":65,"type":66},50,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","This is a prospective, multicentre, single-arm phase II study evaluating a response-adapted kidney-preserving strategy in patients with HER2-positive high-risk upper tract urothelial carcinoma (UTUC). Patients will receive neoadjuvant disitamab vedotin plus tislelizumab, followed by response-adapted local treatment, including kidney-sparing surgery or radical nephroureterectomy based on predefined criteria.\n\nThe primary objective is to assess whether this multimodal strategy can achieve clinically meaningful oncologic control while preserving renal function, as measured by 1-year kidney-intact event-free survival (KI-EFS). Secondary and exploratory objectives include evaluation of clinical response, survival outcomes, safety, renal function preservation, and longitudinal dynamics of circulating and urinary tumor DNA.",[72],"Upper Tract Urothelial Carcinoma",[74,75,76,77],"upper tract urothelial carcinoma","Kidney-Preserving","Disitamab Vedotin","Tislelizumab","NOT_YET_RECRUITING","2026-05-07",{"date":81,"type":82},"2026-05-13","ACTUAL",{"date":84,"type":66},"2026-05-31",{"date":86,"type":66},"2028-12-31",{"name":5,"class":6},1]