[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"upper-tract-urothelial-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:upper-tract-urothelial-carcinoma":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,53,84,112,133,161,192,217,255,276,306,328,351,373,397],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100640859","non-invasive-urinary-genomics-based-risk-assessment-for-early-urothelial-carcinoma-diagnosis-100640859",false,"NCT07614594","Non-invasive Urinary Genomics-Based Risk Assessment for Early Urothelial Carcinoma Diagnosis","Non-invasive Urinary Genomics-Based Risk Assessment for Early Diagnosis of Urothelial Carcinoma","Inclusion Criteria:\n\nPatients are eligible if they meet all of the following criteria:\n\n1. Age ≥ 18 years.\n2. Presence of gross or microscopic hematuria.\n3. Imaging (B-ultrasonography, CT, or MRI) showing a renal pelvic, ureteral, or bladder lesion.\n4. Scheduled for surgery for tissue histopathological diagnosis.\n5. Able to provide written informed consent.\n\nExclusion Criteria\n\n1. Inadequate urine sample (poor quality or insufficient volume).\n2. Lack of final histopathological diagnosis.","ALL","18 Years",{"count":19,"type":20},800,"ESTIMATED","OBSERVATIONAL","This is a two-stage, prospective, single-center observational diagnostic accuracy study evaluating noninvasive urine testing for the detection of urothelial carcinoma (UC). The study enrolls adult patients presenting with gross or microscopic hematuria and imaging evidence of a space-occupying lesion in the renal pelvis, ureter, or bladder, who are scheduled for diagnostic cystoscopy and\u002For surgical tissue sampling. Histopathological examination serves as the reference standard.\n\nStage 1 (Completed, 8th October 2019 - 31st December 2023):\n\nA total of 113 participants have been enrolled. Owing to sufficient research funding, all participants in this stage underwent four urine-based tests: cytology, fluorescence in situ hybridization (FISH), DNA methylation, and a 17-gene mutation panel.\n\nStage 2 (Ongoing, from 1st January 2024):\n\nThe testing protocol was refined to focus on urine DNA methylation alone, owing to limited research funding and the lower cost of DNA methylation compared with the 17-gene mutation panel. As of registration (May 2026), approximately 330 participants have been enrolled.\n\nAll enrolled participants are categorized into two groups based on histopathology: a UC group (including upper tract urothelial carcinoma \\[UTUC\\] and bladder cancer \\[BC\\]) and a non-UC control group. The primary outcome is the diagnostic accuracy (area under the receiver operating characteristic curve \\[AUC\\] with 95% confidence interval, sensitivity, and specificity) of the four urine-based tests in the Stage 1 cohort. The key secondary outcome is the diagnostic accuracy of urine DNA methylation in the Stage 2 cohort. Other secondary outcomes include paired comparisons of AUCs among the four tests in the Stage 1 cohort. Exploratory analyses will include the diagnostic performance of urine cytology in a subset of Stage 2 participants with UTUC, as well as subgroup analyses by tumor site (UTUC vs. BC).\n\nBecause this study is purely observational and non-interventional, prospective registration was not a regulatory or institutional requirement when enrollment began in 2019. This record is being submitted prior to any data analysis to ensure consistency with current research transparency standards.",[24,25,26,27],"Urothelial Carcinoma (UC)","Upper Tract Urothelial Carcinoma","UTUC","Bladder Cancer (BC)",[29,30,31,32,33,34,35,36,37,38,39],"urothelial carcinoma","upper tract urothelial carcinoma","DNA methylation","17 genes mutation","diagnosis","bladder cancer","diagnostic efficacy","urine sample","cytology","fluorescence in situ hybridization","non-invasive detection","RECRUITING","2026-06-30",{"date":43,"type":44},"2026-07-02","ACTUAL",{"date":46,"type":44},"2019-10-08",{"date":48,"type":20},"2030-12-31",{"name":50,"class":51},"Henan Provincial People's Hospital","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":52},"100617637","radical-nephroureterectomy-with-vs-without-template-lymph-node-dissection-in-high-risk-upper-tract-urothelial-carcinoma-t-lnd-utuc-100617637","NCT07321210","Radical Nephroureterectomy With vs Without Template Lymph Node Dissection in High-Risk Upper Tract Urothelial Carcinoma (T-LND UTUC)","Clinical Efficacy and Safety of Radical Nephroureterectomy With Versus Without Template Lymph Node Dissection in High-Risk Upper Tract Urothelial Carcinoma: A Multicenter, Prospective, Randomized Controlled Clinical Trial","UTLUND","Inclusion Criteria:\n\n* Signed written informed consent form (ICF).\n* Age \\> 18 years at the time of ICF signing.\n* Clinical diagnosis of unilateral Upper Tract Urothelial Carcinoma (UTUC) by imaging (enhanced CT or MRI) and\u002For ureteroscopic biopsy\u002Furinary cytology, and scheduled to undergo Radical Nephroureterectomy (RNU).\n* Clinical assessment indicating that the tumor and regional lymph nodes are completely resectable, with at least one of the following high-risk features:\n\n  1. Locally advanced: Preoperative imaging assessed as cT2 stage or higher (i.e., tumor invades muscularis propria or deeper).\n  2. High-grade: Preoperative ureteroscopic biopsy pathology confirmed as high-grade urothelial carcinoma (or with squamous differentiation\u002Fsarcomatoid differentiation).\n  3. Moderate or severe hydronephrosis: Ipsilateral moderate or severe hydronephrosis due to tumor obstruction.\n  4. Large tumor size: Imaging measures maximum tumor diameter \\> 2 cm.\n  5. cN1: Imaging suggests regional lymph node short-axis diameter \\> 1 cm, and the investigator judges it to be resectable.\n* Presence of at least one measurable lesion according to RECIST v1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function meeting the following requirements (without use of any blood components or colony-stimulating factors within 14 days):\n\nBone marrow function: Neutrophils ≥ 1,500\u002Fmm³, Platelets ≥ 100,000\u002Fmm³, Hemoglobin ≥ 9 g\u002FdL (5.6 mmol\u002FL).\n\nRenal function: Serum creatinine ≤ 1.5 mg\u002FdL and\u002For Creatinine clearance ≥ 60 mL\u002Fmin.\n\nLiver function: Total bilirubin ≤ 1.5 × ULN, AST \\& ALT ≤ 1.5 × ULN.\n\n* For women of childbearing potential (WOCBP): Must agree to use a highly effective medically approved contraceptive method during the treatment period and for 3 months after treatment ends. A negative serum or urine pregnancy test within 7 days before enrollment is required; must be non-lactating. For non-sterilized male patients: Must agree to use effective contraception with their partner during the treatment period and for 3 months after treatment ends.\n* Subject voluntarily joins the study, has good compliance, and agrees to undergo safety and survival follow-up.\n\nExclusion Criteria:\n\n* Previous receipt of any anti-tumor therapy for UTUC, including chemotherapy, radiotherapy, immunotherapy, or targeted therapy.\n* History or concurrent presence of muscle-invasive bladder urothelial carcinoma.\n* Preoperative imaging assesses regional lymph nodes as unresectable: lymph nodes fused into a massive conglomerate, or fully encasing the abdominal aorta\u002Finferior vena cava\u002Fpelvic vessels preventing safe separation.\n* Known bilateral UTUC or hereditary diseases that definitively increase the risk of contralateral upper tract tumors, such as Lynch Syndrome.\n* Diagnosis of other active malignancies within the past 5 years (except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix which have been cured and show no recurrence within 5 years).\n* Presence of any active autoimmune disease or history of autoimmune disease.\n* Current use of immunosuppressants for immunosuppressive purposes, continued within 2 weeks prior to enrollment.\n* Poorly controlled cardiac clinical symptoms or diseases.\n* Coagulation abnormalities or bleeding tendency.\n* Presence of specific active gastrointestinal conditions or uncontrolled tumor bleeding.\n* History of significant bleeding, hemoptysis, or thromboembolic events within specified timeframes.\n* Active infection or unexplained fever \\> 38.5°C during screening or before the first dose.\n* Occurrence of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to surgery.\n* History or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired pulmonary function, etc.\n* Congenital or acquired immunodeficiency.\n* Participation in another clinical study within 1 month prior to enrollment, or potential receipt of other systemic anti-tumor therapy during the study period.\n* Known history of psychotropic drug abuse, alcohol abuse, or drug use.\n* Inability or unwillingness to bear the out-of-pocket costs of examinations and treatments.\n* Any other condition deemed by the investigator to make the subject unsuitable for participation.",{"count":62,"type":20},150,"INTERVENTIONAL",[65],"NA","The goal of this clinical trial is to learn if adding a template lymph node dissection (TLND) to the standard surgery for upper tract urothelial cancer (UTUC) can improve patient survival and prevent the cancer from recurrence. The main questions it aims to answer are:\n\nDo patients who receive standard surgery with LND live longer without their cancer returning? Is adding LND safe, and how does it affect surgery-related complications? Researchers will compare the group receiving standard surgery plus LND to the group receiving standard surgery alone to see if adding LND is more effective.\n\nParticipants will:\n\nBe randomly assigned to one of the two surgical groups. Undergo their assigned surgery and recover in the hospital. Attend regular follow-up visits for checkups and scans for 5 years to monitor for cancer recurrence, with the possibility of long-term follow-up extending to 10 years.",[25,68],"Lymph Node Dissection",[70,71,72,73,74],"Upper tract urothelial carcinoma (UTUC)","Template Lymph node dissection","Nephroureterectomy","High-risk neoplasm","Randomized Controlled Trial","2026-06-22",{"date":77,"type":44},"2026-06-25",{"date":79,"type":44},"2025-09-01",{"date":81,"type":20},"2032-08-30",{"name":83,"class":51},"Tianjin Medical University Second Hospital",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":63,"phases":94,"briefSummary":96,"conditions":97,"keywords":98,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":52},"100638386","phase-2-biomarker-enriched-kidney-preserving-strategy-with-disitamab-vedotin-plus-tislelizumab-in-her2-positive-high-risk-upper-tract-urothelial-carcinoma-100638386","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.","85 Years",{"count":93,"type":20},50,[95],"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.",[25],[30,99,100,101],"Kidney-Preserving","Disitamab Vedotin","Tislelizumab","NOT_YET_RECRUITING","2026-05-07",{"date":105,"type":44},"2026-05-13",{"date":107,"type":20},"2026-05-31",{"date":109,"type":20},"2028-12-31",{"name":111,"class":51},"RenJi Hospital",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":63,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":52},"100635813","flexible-ureterorenoscopy-for-surveillance-of-upper-tract-urothelial-carcinoma-100635813","NCT07557563","Flexible Ureterorenoscopy for Surveillance of Upper Tract Urothelial Carcinoma","Flexible Ureterorenoscopy for Surveillance of Upper Tract Urothelial Carcinoma - A Pilot Study","Inclusion Criteria:\n\n1. Aged 18 years or older\n2. Capable of giving informed consent\n3. Having undergone an kidney-sparing surgery (endoscopic operation or segmental ureterectomy)\n\nExclusion Criteria:\n\n1. Allergy to transurethral lidocaine jelly\n2. On anticoagulation or anti-platelet medication with contraindications for cessation prior to the procedure\n3. Structural abnormalities in the upper urinary tract on the intended side of examination",{"count":120,"type":20},10,[65],"It is a prospective single-arm pilot study to investigate the safety and feasibility of flexible ureteroscopy under local anaesthesia.",[25],"2026-04-29",{"date":126,"type":44},"2026-05-05",{"date":128,"type":20},"2026-06-01",{"date":130,"type":20},"2028-03-31",{"name":132,"class":51},"Chinese University of Hong Kong",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":52},"100631765","multimodal-kidney-sparing-strategy-for-high-risk-upper-tract-urothelial-carcinoma-100631765","NCT07504939","Multimodal Kidney-Sparing Strategy for High-Risk Upper Tract Urothelial Carcinoma","Evaluating a Kidney-sparing Strategy Combining Endoscopic Surgery, Adjuvant Radiotherapy, and HER2-targeted Antibody-Drug Conjugate in High-risk Upper Tract Urothelial Carcinoma: Study Protocol for a Prospective, Multicenter, Non-randomized Comparative Clinical Trial","Inclusion Criteria\n\nParticipants must meet all of the following criteria:\n\nAge 18 years or older Voluntary participation with written informed consent Pathology indicating upper tract urothelial carcinoma with HER2 at least 1+ expression Clinical stage cT1-T2N0M0 based on imaging evaluation Classified as high-risk upper tract urothelial carcinoma according to European Association of Urology (EAU) criteria Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Adequate renal function with split renal function of the affected kidney ≥10 mL\u002Fmin on renal dynamic scintigraphy Expected life expectancy greater than 24 months Ability and willingness to comply with study procedures and follow-up schedule Exclusion Criteria\n\nParticipants will be excluded if any of the following conditions are present:\n\nInability to tolerate or refusal of kidney-sparing treatment Evidence of advanced disease (≥T3), lymph node metastasis, or distant metastasis Synchronous bladder urothelial carcinoma or other urological malignancies Previous systemic anticancer therapy, including chemotherapy, targeted therapy, immunotherapy, or antibody-drug conjugates Prior radiotherapy involving the urinary tract or retroperitoneal region Severe uncontrolled comorbidities such as cardiovascular, pulmonary, neurological, psychiatric, or systemic diseases Active severe infections requiring systemic antimicrobial therapy Known immune-related disorders requiring long-term immunosuppressive treatment Pregnancy or breastfeeding Known allergy to investigational drugs used in this study Concurrent participation in another therapeutic clinical trial Indeterminate postoperative pathological diagnosis",{"count":141,"type":20},36,"UTUC is a cancer that develops in the lining of the kidney or ureter. The standard treatment is radical nephroureterectomy, which removes the kidney and ureter. Although this surgery can control the cancer, it permanently reduces kidney function.\n\nEndoscopic treatment can serve as a kidney-sparing approach for low-risk UTUC; however, in high-risk patients, the high rate of upper tract local recurrence after endoscopic treatment remains the primary failure pattern. This study aims to evaluate the efficacy and safety of radiotherapy-involved kidney-sparing treatment for UTUC.\n\nThe main questions this study aims to answer are: Can this multimodal kidney-sparing strategy reduce local recurrence of UTUC compared with endoscopic treatment alone? Participants in the kidney-sparing group will: Undergo endoscopic surgery to remove the tumor; Receive systemic therapy with disitamab vedotin and toripalimab; Receive targeted radiotherapy after surgery.\n\nParticipants will undergo regular follow-up visits, including imaging examinations and endoscopic evaluations, to monitor for recurrence or disease progression.\n\nThe results of this study may help determine whether a multimodal kidney-sparing treatment strategy could become a safe and effective option for selected patients with high-risk UTUC.",[144,25],"Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy",[26,146,147,100,148,149,150,151],"Kidney-Sparing Surgery","Endoscopic Treatment","Toripalimab","HER2-Targeted Therapy","Radiotherapy","Multimodal Therapy","2026-04-21",{"date":154,"type":44},"2026-04-24",{"date":156,"type":20},"2026-04-01",{"date":158,"type":20},"2030-04-01",{"name":160,"class":51},"Peking University First Hospital",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":63,"phases":170,"briefSummary":171,"conditions":172,"keywords":173,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":52},"100588987","phase-2-photodynamic-diagnosis-of-upper-tract-urothelial-carcinoma-using-fluorescence-endoscopy-and-oral-5-ala-100588987","NCT06948552","Photodynamic Diagnosis of Upper Tract Urothelial Carcinoma Using Fluorescence Endoscopy and Oral 5-ALA","A Phase II Study on Photodynamic Diagnosis of Urological Cancer in the Upper Urinary Tract Using Fluorescence Endoscopy With Cystoscopy and Ureteroscopy With 5-ALA","Inclusion Criteria:\n\n* Patients aged 18 or older undergoing diagnostic or therapeutic ureteroscopy for a known or suspected upper tract urothelial tumor\n* Able to provide informed consent\n* Able to comply with study requirements\n\nExclusion Criteria:\n\n* Known porphyria or hypersensitivity to porphyrins\n* Pregnant or breastfeeding women\n* AST or ALT \\> 2x upper limit of normal within 30 days prior to surgery\n* Participation in another investigational study within 30 days\n* Known allergy or contraindication to 5-ALA or its components","75 Years",{"count":120,"type":20},[95],"This study is evaluating whether a medication called 5-aminolevulinic acid (5-ALA), approved by the FDA for use in brain surgery, can help improve the visibility of upper tract urothelial tumors during surgery. Patients undergoing ureteroscopic tumor resection will receive 5-ALA prior to surgery, and surgeons will use special blue light to help identify abnormal tissue that might not be seen under standard white light. The goal is to assess whether this technique can enhance tumor detection and removal.",[25],[174,175,176,177,178,179,180,181,182,183],"Photodynamic Diagnosis","5-ALA","Gleolan","Ureteroscopy","Fluorescence Endoscopy","Urothelial Cancer","Blue Light","Kidney Cancer","Urologic Oncology","Minimally Invasive Surgery","2026-03-26",{"date":156,"type":44},{"date":187,"type":20},"2026-04",{"date":189,"type":20},"2028-01",{"name":191,"class":51},"Henry Ford Health System",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":63,"phases":202,"briefSummary":203,"conditions":204,"keywords":205,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":52},"100631302","phase-2-disitamab-vedotin-plus-radiotherapy-for-adjuvant-treatment-of-her2-expressing-cisplatin-ineligible-upper-tract-urothelial-carcinoma-100631302","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.",{"count":201,"type":20},192,[95],"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.",[25],[26,206,100,150,207,208,25],"HER2","Adjuvant Therapy","Cisplatin-Ineligible","2026-03-23",{"date":211,"type":44},"2026-03-27",{"date":213,"type":20},"2026-05-01",{"date":215,"type":20},"2034-03-01",{"name":160,"class":51},{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":168,"enrollmentInfo":225,"targetDuration":4,"studyType":63,"phases":227,"briefSummary":229,"conditions":230,"keywords":235,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":52},"100630819","phase-1-dual-target-nectin-4her2-car-nk-cells-in-advanced-urothelial-carcinoma-100630819","NCT07492628","Dual-Target Nectin-4\u002FHER2 CAR-NK Cells in Advanced Urothelial Carcinoma","A Phase 1, Open-Label, Multicenter, Non-Randomized, Dose-Escalation and Dose-Expansion Study of Allogeneic Dual-Target Nectin-4\u002FHER2 CAR-NK Cells Following Fludarabine\u002FCyclophosphamide Lymphodepletion in Adults With Relapsed\u002FRefractory, Locally Advanced or Metastatic Urothelial Carcinoma","DUET-UC-NK","Inclusion Criteria:\n\n* Age 18-75 years at consent.\n* Histologically confirmed urothelial carcinoma of the bladder, ureter, renal pelvis, or urethra that is unresectable locally advanced or metastatic.\n* Disease progression after, intolerance to, or ineligibility for standard therapy, including platinum-based chemotherapy and PD-1\u002FPD-L1 blockade when appropriate for the patient and region. Prior enfortumab vedotin and prior HER2-directed therapy are allowed, but a fresh biopsy is strongly preferred after the latest systemic regimen.\n* At least one measurable lesion per RECIST v1.1.\n* Tumor tissue available for central review demonstrating Nectin-4 positivity (for example, IHC ≥1+ in ≥10% tumor cells) and HER2 status assessed by IHC\u002FISH. At least one of the selected therapeutic targets must be present; dose expansion preferentially enrolls Nectin-4-positive disease.\n* ECOG performance status 0-1.\n* Adequate bone marrow, hepatic, renal, and coagulation function.\n* Life expectancy of at least 12 weeks.\n* Negative pregnancy test for women of childbearing potential and agreement to use highly effective contraception during study treatment and follow-up as defined in the protocol.\n* Ability to understand and sign informed consent.\n\nExclusion Criteria:\n\n* Active or untreated central nervous system metastases or leptomeningeal disease. Previously treated CNS disease is allowed if clinically stable and off escalating corticosteroids.\n* Prior allogeneic hematopoietic stem cell transplant, prior solid-organ transplant, or active graft-versus-host disease.\n* Clinically significant autoimmune disease requiring systemic immunosuppression within the defined washout window.\n* Uncontrolled infection, including uncontrolled hepatitis B, hepatitis C, HIV, sepsis, or active tuberculosis.\n* Clinically significant cardiac disease, active myocarditis, unstable angina, recent myocardial infarction, uncontrolled arrhythmia, or clinically meaningful decline in left ventricular ejection fraction that would increase risk from HER2-directed cell therapy.\n* Clinically significant pulmonary disease (for example, uncontrolled interstitial lung disease or oxygen-dependent respiratory compromise).\n* Use of systemic corticosteroids or other immunosuppressive medications above protocol-allowed limits within the washout window.\n* History of severe hypersensitivity to fludarabine, cyclophosphamide, or cell-product excipients.\n* Pregnancy or breastfeeding.\n* Another active malignancy requiring systemic therapy or likely to interfere with protocol assessments, except for protocol-allowed low-risk cancers.",{"count":226,"type":20},42,[228],"PHASE1","This hypothetical first-in-human study is designed to evaluate the safety, feasibility, and preliminary anti-tumor activity of an allogeneic dual-target Nectin-4\u002FHER2 CAR-NK cell product in adults with relapsed\u002Frefractory locally advanced or metastatic urothelial carcinoma. Based on public urothelial-cancer evidence, Nectin-4 was selected as the lead antigen because it has the strongest disease-specific clinical validation; HER2\u002FERBB2 was chosen as the secondary co-target to broaden tumor coverage and reduce antigen-escape risk. EpCAM is not selected as a therapeutic co-target in this example because of broader normal epithelial expression and weaker tumor specificity in urothelial carcinoma.",[231,232,233,234,25],"Bladder Cancer","Urothelial Carcinoma","Metastatic Urothelial Carcinoma","Locally Advanced Urothelial Carcinoma",[236,237,238,206,239,29,34,240,241,242,243,244],"CAR-NK","allogeneic NK cells","Nectin-4","ERBB2","dual-target","lymphodepletion","solid tumor immunotherapy","EpCAM","RP2D","2026-03-20",{"date":247,"type":44},"2026-03-25",{"date":249,"type":44},"2026-03-02",{"date":251,"type":20},"2028-05-17",{"name":253,"class":254},"Beijing Biotech","INDUSTRY",{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":63,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":52},"100519224","a-home-based-prehabilitation-exercise-intervention-for-improving-physical-function-in-patients-with-bladder-cancer-and-upper-tract-urothelial-cancer-get-moving-trial-100519224","NCT06040762","A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients With Bladder Cancer and Upper Tract Urothelial Cancer, Get Moving Trial","The \"Get Moving Trial\": A Phase I\u002FII RCT of Home-Based (P)Rehabilitation With ExerciseRx in Bladder Cancer and Upper Tract Urothelial Cancer","Inclusion Criteria:\n\n* 18 years of age or older\n* English-speaking\n* Planned treatment with radical cystectomy or radical nephroureterectomy\u002Fureterectomy with or without preceding systemic therapy as indicated by the patient's surgeon with enough time to complete a minimum of 4 weeks of exercises before surgery if enrolled in the (P)REHAB arm\n* Willing and able to participate in trial activities\n\nExclusion Criteria:\n\n* Cognitive\u002Fmental impairment that will preclude ability to participate in routine exercise activities. Significant cognitive or memory impairment or baseline dementia that would preclude a patient's ability to follow instructions or reproduce exercises\n* Immobility, inability\u002Funwillingness to perform personalized exercise program. Inability to perform exercises safely from seated or standing position at home or recent falls or high fall risk. Neurologic or orthopedic condition(s) that restricts participation in unsupervised home exercises, such as prior stroke with neurologic impairment, weight-bearing precautions, or unwillingness to participate in exercises\n* Participants who have nonmuscle-invasive urothelial cancer of the bladder\u002Fupper tract anticipating undergoing organ-preserving treatments, or radiographic evidence of metastatic disease involving other organs including brain metastases.\n* Patients with predominant histology other than urothelial carcinoma of the bladder or upper tracts (e.g. metastasis from another cancer) who would not otherwise be considered candidates for standard definitive or consolidative surgeries (radical cystectomy, ureterectomy, radical nephroureterectomy) with\u002Fwithout treatment with preoperative\u002Fneoadjuvant systemic therapy.\n* Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study\n* Inability to understand or read English\n* Lack of access or lack of sufficient facility to use an Android or iOS smart device with the minimum criteria for using ExerciseRx\n* Not receiving surgery at UWMC\n* Participation in a clinical trial that does not permit enrollment in the Get Moving trial",{"count":263,"type":20},128,[65],"Prehabilitation refers to the process of improving a patient's functional capabilities prior to a surgical procedure with the goal of decreasing post-surgical inactivity and physical decline. This clinical trial evaluates the utility of a personalized home-based prehabilitation exercise intervention for the improvement of physical function and surgical outcomes in patients with urothelial carcinoma undergoing definitive or consolidative surgery of the bladder (radical cystectomy) or upper tract (nephroureterectomy, ureterectomy) with or without preceding neoadjuvant\u002Fsystemic therapy. The exercise intervention includes at-home exercise sessions focused on the improvement of core strength and balance as well as personalized step count goals, delivered to patients remotely via a smart-device-based application (ExerciseRx). Encouraging physical activity before surgery may improve physical function and surgical outcomes in patients who are scheduled to undergo surgery for their bladder or urothelial cancer.",[231,232,25,267],"Renal Pelvis and Ureter Urothelial Carcinoma","2026-02-26",{"date":249,"type":44},{"date":271,"type":44},"2023-12-19",{"date":273,"type":20},"2027-04-30",{"name":275,"class":51},"University of Washington",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":284,"enrollmentInfo":285,"targetDuration":4,"studyType":63,"phases":287,"briefSummary":288,"conditions":289,"keywords":290,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":52},"100624633","phase-2-nectar-study-neoadjuvant-toripalimab--9mw2821-for-local-utuc-100624633","NCT07412171","NECTAR Study: Neoadjuvant Toripalimab + 9MW2821 for Local UTUC","NECTAR Study: A Multicenter, Open-label, Randomized Phase II Study of Neoadjuvant Toripalimab Plus 9MW2821 Versus Upfront Radical Nephroureterectomy With\u002FWithout Lymph Node Dissection in Patients With Local Upper Tract Urothelial Carcinoma (UTUC)","NECTAR","Inclusion Criteria:\n\n* Adults aged 18 to 80 years, male or female.\n* Histologically confirmed upper tract urothelial carcinoma (UTUC) involving the renal pelvis and\u002For ureter, with predominant (≥50%) urothelial histology.\n* Treatment-naïve, non-metastatic disease (M0) with clinical stage T1-T3, as determined by imaging.\n* Eligible for and willing to undergo radical nephroureterectomy with or without lymph node dissection.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, hepatic, renal, and cardiac function as defined by the protocol.\n* Availability of tumor tissue for biomarker analyses.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior systemic anti-tumor therapy for urothelial carcinoma, except for intravesical therapy for non-muscle-invasive disease.\n* Prior treatment with a programmed cell death 1 (PD-1) inhibitor, programmed cell death ligand 1 or 2 (PD-L1\u002FL2) inhibitor, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor, or antibody-drug conjugate.\n* Evidence of metastatic disease (M1) or regional lymph node involvement of N2 or higher.\n* Prior systemic anticancer therapy, including investigational agents, within 3 years prior to study enrollment.\n* Prior radiotherapy to the bladder or upper urinary tract.\n* Active autoimmune disease requiring systemic treatment.\n* Active or uncontrolled infection, including known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) infection, or active tuberculosis.\n* Receipt of a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment.\n* History of allogeneic tissue or solid organ transplantation.\n* Uncontrolled diabetes mellitus, defined as hemoglobin A1c ≥8%, or hemoglobin A1c ≥7% to \\\u003C8% with associated diabetes-related symptoms.\n* Clinically significant cardiovascular disease or thromboembolic events that, in the investigator's judgment, would increase study risk.\n* Ongoing peripheral sensory or motor neuropathy of Grade 2 or higher.\n* Known psychiatric disorder or substance abuse that would interfere with study participation or compliance.\n* Pregnancy or breastfeeding.\n* Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study.","80 Years",{"count":286,"type":20},40,[95],"The NECTAR study is a multicenter, open-label, randomized phase II clinical trial designed to evaluate a neoadjuvant treatment strategy in patients with localized upper tract urothelial carcinoma (UTUC).\n\nIn this study, eligible participants will be randomly assigned to receive either neoadjuvant treatment with toripalimab plus the investigational drug 9MW2821 followed by radical nephroureterectomy with or without lymph node dissection, or upfront radical nephroureterectomy with or without lymph node dissection as standard of care. The purpose of the study is to compare the pathologic response at the time of surgery between the two treatment approaches and to assess treatment safety.\n\nParticipants will be monitored throughout treatment and follow-up for treatment response, adverse events, and other clinical outcomes. The information obtained from this study may help improve future treatment strategies for patients with localized UTUC.",[25],[26,148,291,292,293,294,295,296],"9MW2821","Neoadjuvant Therapy","Radical Nephroureterectomy","Immunotherapy","Phase II","Pathologic Complete Response","2026-02-13",{"date":299,"type":44},"2026-02-17",{"date":301,"type":20},"2026-02",{"date":303,"type":20},"2028-12",{"name":305,"class":51},"Peking University Third Hospital",{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":16,"minAge":313,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":63,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":52},"100610268","phase-2-cisplatin-based-chemotherapy-followed-by-maintenance-avelumab-in-utuc-100610268","NCT07225374","Cisplatin-Based Chemotherapy Followed by Maintenance Avelumab in UTUC","A Prospective Phase II Study of Adjuvant Cisplatin-Based Chemotherapy Followed by Maintenance Avelumab in Upper Tract Urothelial Carcinoma","Inclusion Criteria:\n\n* Must be aged 19 years or more\n* Must have histologically or cytologically proven UTUC arising from renal pelvis and\u002For ureter.\n* Must have histological evidence of high-risk muscle-invasive disease (i.e., pT2\\~ T4) and\u002For N+ disease.\n* Must have an ECOG performance status of 0 to 1\n* Received at least 3 or 4 cycles of adjuvant cisplatin-based chemotherapy, and proved to have no evidence of disease recurrence with imaging studies, urine cytology and cystoscopy\n* At least 3 weeks since the last surgical procedures or chemotherapy prior to enrolment. Subjects must have recovered to \\\u003CGrade 2 from all acute toxicities or toxicity must be deemed irreversible by the investigator.\n* Adequate marrow function without growth factor support or transfusion dependency A. Neutrophil 1,500 cells\u002FμL or more B. Platelet count 100,000\u002FμL or more C. Hemoglobin 9.0 g\u002FdL or more\n* Adequate renal function with serum creatinine 1.5 x ULN or a calculated creatinine clearance ≥ 50 mL\u002Fmin using the CockcroftGault or MDRD formulas\n* Adequate hepatic function A. Bilirubin 1.5 times upper limit of normal (x ULN) or less; does not apply to subjects with Gilbert's syndrome diagnosed as per institutional guidelines. B. AST (SGOT) and ALT (SGPT) 3 x ULN or less; if liver metastases are present, then 5 x ULN is allowed.\n* Women of childbearing potential must use effective contraception continuously for at least 30 days after the final dose of avelumab. At least one method classified as \"highly effective\" (failure rate \\\u003C 1%) must be employed (see Table 1).\n* Written and voluntary informed consent understood, signed and dated.\n* Negative serum or urine pregnancy test at screening for women of childbearing potential.\n\nExclusion Criteria\n\n* Ongoing treatment with an anticancer agent not contemplated in this protocol\n* Radiologic finding consistent with metastatic disease\n* Severe medical or psychological illness that preclude participation to study, including any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years, New York Heart Association (NYHA) grade III or greater congestive heart failure, cerebrovascular attack within the prior year, or current serious cardiac arrhythmia requiring medication except atrial fibrillation\n* Non-tolerable \\> Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1\n* Major surgery, other than diagnostic surgery or transurethral resection, within 4 weeks prior to Cycle 1 Day 1, without complete recovery\n* Double primary cancer of other site(s) or a history of other malignancies, except for cured ones at the discretion of investigator\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.\n* Subjects who have exhibited allergic reactions to study treatment.\n* Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.\n* Subject with legal incapacity or limited legal capacity. Dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol. Unwillingness or inability to comply with the study protocol for any reason.\n* Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). 12) Active autoimmune disease requiring systemic immunosuppressive treatment. Patients with controlled autoimmune disease not requiring systemic immunosuppressive treatment including diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.\n* Prior organ transplantation including allogenic stem-cell transplantation.\n* Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines.\n* Persisting toxicity related to prior therapy (NCI CTCAE Grade \\>\n\n  1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.\n* Lactating Women Must discontinue breastfeeding during study treatment and for at least 30 days after administration of the final dose of study drug.","20 Years",{"count":315,"type":20},48,[95],"A Prospective Phase II Study of Adjuvant Cisplatin-Based Chemotherapy followed by Maintenance Avelumab in Upper Tract Urothelial Carcinoma",[25],"2025-11-04",{"date":321,"type":44},"2025-11-06",{"date":323,"type":44},"2025-09-16",{"date":325,"type":20},"2029-07-02",{"name":327,"class":51},"Samsung Medical Center",{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":63,"phases":335,"briefSummary":336,"conditions":337,"keywords":338,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":350},"100581327","phase-1-ambulatory-flexible-urs-for-utuc-surveillance-100581327","NCT06848868","Ambulatory Flexible URS for UTUC Surveillance","Flexible Ureterorenoscopy for Surveillance of Upper Tract Urothelial Carcinoma-A Pilot Study",{"count":120,"type":20},[228],"This is a a prospective single-arm pilot study to investigate the safety and feasibility of flexible ureteroscopy under local anaesthesia. All consecutive patients who have undergone kidney-sparing surgery for managing upper tract urothelial carcinoma will be screened for study eligibility. The primary outcome is the procedural technical success rate. Secondary outcomes include the 30-day complication rate following flexible ureteroscopy, readmission rates, cost analysis, and patient-reported outcomes. Ureterorenoscopy will be conducted in the recruited patients under local anaesthesia in the ambulatory urology centre. Procedural details, technical success rates, adverse events and patient reported outcomes will be documented. The anticipated risks of this intervention are not expected to exceed those associated with the standard of care, that is ureterorenoscopy under anaesthesia. This pilot study aims to recruit a total of 10 subjects to assess the safety and feasibility of flexible ureterorenoscopy in an ambulatory care setting.",[25],[26,339,340,341],"Upper tract urothelial carcinoma","Ureterorenoscopy","Flexible ureterorenoscopy","2025-09-09",{"date":344,"type":44},"2025-09-15",{"date":346,"type":44},"2025-07-01",{"date":348,"type":20},"2029-06-30",{"name":132,"class":51},2,{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":63,"phases":360,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":52},"100602638","phase-2-neoadjuvant-tislelizumab-in-combination-with-nab-paclitaxel-for-utuc-100602638","NCT07126119","Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for UTUC","Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for Upper Tract Urothelial Carcinoma: An Open-Label, Single-Center, Single-Arm, Phase II Clinical Trial (TRUCE-U02)","Inclusion Criteria:\n\n1. Males or females aged no less than 18 years old;\n2. UTUC indicated by ureteroscopic biopsy and imageological examination (including CT, MRI, or PET-CT), without evidences of metastasis in chest CT scan and abdominal CT scan (T1-4N0-2M0); High risk disease confirmed in accordance with the EAU guidelines.\n3. Histologically confirmed urothelial carcinoma or urothelial carcinoma as the major pathological component \\>50% in the specimen from ureteroscopic biopsy;\n4. Suitable and planned to receive RNU.\n5. Expected survival time of more than 12 weeks;\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;\n\n6.Agree to provide blood, urine, and tissue samples (for testing PD-L1 expression, HER-2, tumor mutation burden, etc.); 7.The organ function levels must meet the following requirements: Hematological indicators: Absolute neutrophil count ≥1.5×10\\^9\u002FL, platelet count ≥80×10\\^9\u002FL, hemoglobin ≥6.0 g\u002FdL (can be maintained through symptomatic treatment); Liver function: Total bilirubin ≤1.5 times the upper limit of normal, alanine transaminase and aspartate transaminase ≤2.5 times the upper limit of normal; Renal function: Baseline ECT renography indicates a total renal glomerular filtration rate (GFR) ≥15 ml\u002Fmin.\n\n8.Participants are willing to join the study and be able to sign and comply the protocol.\n\nExclusion Criteria:\n\n1. Concurrent primary malignancies in other sites are excluded, except for those with a history of other malignancies that have been treated and are currently stable.\n2. Confirmed bilateral upper tract urothelial carcinoma (UTUC).\n3. Presence of urothelial carcinoma in bladder is excluded, except for non-muscle-invasive bladder cancer that can be completely resected via transurethral resection of bladder tumor (TURBT).\n4. Received a live attenuated vaccine within 4 weeks before treatment or plan to receive during the study period;\n5. Active, known or suspected history of autoimmune disease;\n6. Known history of primary immunodeficiency;\n7. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n8. Pregnant or breastfeeding female patients;\n9. Untreated acute or chronic active Hepatitis B or Hepatitis C infection. Patients receiving antiviral therapy may be eligible if viral load is under monitored, at the discretion of the physician based on the patient's individual condition;\n10. Receiving immunosuppressive medication within 4 weeks prior to starting treatment, except nasal, inhaled, topical steroids, or systemic corticosteroids at physiological doses (i.e., not exceeding 10 mg\u002Fday of prednisone or equivalent dose of other corticosteroids);\n11. Known or suspected allergy to Tislelizumab or Nab-Paclitaxel;\n12. Active tuberculosis;\n13. Previous treatment with PD-1\u002FPD-L1\u002FCTLA-4 immune checkpoint inhibitors or other immunotherapies;\n14. Participation in another clinical study;\n15. Fertile men or women without effective contraception;\n16. Uncontrolled concurrent illness, including but not limited to:\n\n(1)HIV infection (HIV antibodies positive); (2)Uncontrolled severe infection; (3)Uncontrolled systemic disease (such as severe psychiatric, neurological disorders, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver, or kidney disease, uncontrolled hypertension \\[i.e., hypertension of CTCAE grade 2 or higher despite treatment\\]); (4)Active hemorrhage or newly developed thrombotic disease. (5)Renal failure with CKD grade 5 and undergoing dialysis treatment.",{"count":359,"type":20},35,[95],"This study is designed as an open-label, single-arm, single center, phase II clinical trial, aiming to evaluate the efficacy of neoadjuvant Tislelizumab combined with Nab-Paclitaxel for patients with non-metastatic upper tract urothelial carcinoma (UTC). Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo radical nephroureterectomy (RNU). The assessment of efficacy is based on the histology of specimen from RNU, and treatment-related adverse events (TRAEs) will be recorded and evaluated according to CTCAE 5.0.",[25,292,363,364],"PD-1 Inhibitor","Nab-paclitaxel","2025-08-15",{"date":367,"type":44},"2025-08-17",{"date":369,"type":44},"2025-07-05",{"date":371,"type":20},"2030-12-30",{"name":83,"class":51},{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":284,"enrollmentInfo":380,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":382,"conditions":383,"keywords":384,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":4},"100577434","heftme-system-for-adjuvant-therapeutic-selection-of-locally-advanced-utuc-postoperativelya-perspective-cohort-study-100577434","NCT06798246","HEFTME System for Adjuvant Therapeutic Selection of Locally Advanced UTUC Postoperatively：A Perspective Cohort Study","Hematoxylin-eosin Staining-based Tumor Microenvironment Subtype System Adjuvant Therapeutic Selection for Locally Advanced Upper Tract Urothelial Carcinoma After Radical Surgery：A Perspective Cohort Study","Inclusion Criteria:\n\n* pathological diagnose of UTUC;\n* Met more than muscle-invasion stages(pT2+) or lymph nodes metastasis.\n\nExclusion Criteria:\n\n* Patients with early-local stages (pTa\u002FT1\u002FTis) without LNM+ and those with incomplete pathologic and prognostic information were excluded",{"count":381,"type":20},200,"This multicenter, real-world study introduces a novel Hematoxylin-eosin staining(H\\&E)-based four tumor microenvironment (TME) system (HEFTME system) assisting in prognostic prediction and precise adjuvant treatment selection for laUTUC postoperatively.",[25],[385,386,387,388],"HE-stained slides","Tumor microenvironment","Precise subtype","Adjuvant therapy","2025-01-22",{"date":391,"type":44},"2025-01-29",{"date":393,"type":20},"2025-02-01",{"date":395,"type":20},"2030-01-01",{"name":160,"class":51},{"id":398,"slug":399,"hasResults":11,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":403,"eligibilityCriteria":404,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":63,"phases":407,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":416,"locationsCount":52},"100509724","phase-2-a-study-of-rc48-adc-combined-with-js001-for-postoperative-adjuvant-treatment-of-upper-tract-urothelial-carcinoma-100509724","NCT05917158","A Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma","An Open-label, Single-arm Study to Evaluate the Efficacy and Safety of RC48-ADC Combined with JS001 in Postoperative Adjuvant Treatment of HER2-positive Upper Tract Urothelial Carcinoma (UTUC)","1","Inclusion Criteria:\n\n* Written informed consent\n* ≥18 years of age\n* Post radical nephro-ureterectomy for upper tract tumour with predominant TCC component-squamoid differentiation or mixed TCC\u002FSCC is permitted.\n* Histologically confirmed TCC staged pT2-pT4 pN0-2 M0 or pTany N1-2 M0 (providing all grossly abnormal nodes are resected).\n* Pathological tissue immunohistochemistry HER2 2\\~3+\n* Fit and willing to receive adjuvant therapy with first cycle to be commenced within 90 days of radical nephro-ureterectomy if allocated\n* ECOG(Eastern Cooperative Oncology Group) performance is 0\\~2.\n* Available for long-term follow-up\n\nExclusion Criteria:\n\n* Evidence of distant metastases\n* Pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology\n* Un-resected macroscopic nodal disease\n* Concurrent muscle invasive bladder cancer (patients with concurrent Non-muscle invasive bladder cancer (NMIBC) will be eligible)\n* Significant co-morbid conditions that would interfere with administration of protocol treatment\n* Pregnancy; lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception (male patients should also use contraception if sexually active);\n* Previous malignancy in the last 5 years except for previous NMIBC, adequately controlled non melanoma skin tumours, CIS of cervix or LCIS of breast or localised prostate cancer in patients who have a life expectancy of over 5 years upon trial entry.",{"count":406,"type":20},30,[95],"This study will evaluate the efficacy and safety of intravenous RC48-ADC combined with JS001 in postoperative adjuvant therapy for HER2-positive upper tract urothelial carcinoma.",[410,25,26],"Carcinoma","2025-01-20",{"date":389,"type":44},{"date":414,"type":44},"2022-11-23",{"date":303,"type":20},{"name":417,"class":51},"Jinling Hospital, China"]