[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"upper-urinary-tract-urothelial-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:upper-urinary-tract-urothelial-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,50,81,111,130,154,175,200],{"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":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100575580","phase-3-a-phase-3-single-arm-study-of-ugn-104-for-the-treatment-of-low-grade-upper-tract-urothelial-cancer-100575580",false,"NCT06774131","A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer","A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-104, a Novel Formulation of UGN-101, for the Treatment of Patients With Low-grade Upper Tract Urothelial Cancer (LG-UTUC)","Inclusion Criteria:\n\n1. Provide written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and protocol.\n2. Naive or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system, with the following disease characteristics:\n\n   1. At least 1 measurable papillary LG tumor, evaluated visually, ≤ 15 mm. The largest lesion should not exceed 15 mm. Debulking to ≤ 15 mm is permitted.\n   2. Biopsy taken from at least 1 tumor located above the ureteropelvic junction revealing LG urothelial carcinoma (UC). Patients who have been biopsied within 8 weeks before Screening for this study and shown to have LG UC may have these historical biopsies used for enrollment into the study and do not require repeat biopsy during Screening.\n   3. Patient should have at least 1 remaining papillary LG tumor evaluated visually with a diameter of at least 5 mm post-biopsy.\n   4. Wash urine cytology sampled from the pyelocalyceal system documenting the absence of high-grade (HG) UC, diagnosed not more than 8 weeks before Screening.\n   5. Patients with bilateral LG-UTUC may be enrolled if at least 1 side meets the inclusion criteria for the study and if the other kidney does not require further treatments. (The disease in the other kidney must be completely ablated before receiving treatment in the study.) Note: If both upper tracts meet inclusion criteria, the treating urologist in consultation with the sponsor's medical monitor can decide which side to treat in the study. The pyelocalyceal system not under study must be free of cancer before the first instillation on the side to be treated in the study.\n3. Patients with Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C 3 (with Karnofsky \\> 40).\n4. Patients with life expectancy \\> 24 months at time of Screening.\n5. Patients must have adequate organ and bone marrow function as determined by the following routine laboratory tests:\n\n   1. Leukocytes ≥ 3,000\u002FμL (≥ 3 × 10\\^9\u002FL).\n   2. Absolute neutrophil count ≥ 1,500\u002FμL (≥ 1.5 × 10\\^9\u002FL).\n   3. Platelets ≥ 100,000\u002FμL (≥ 100 × 10\\^9\u002FL).\n   4. Hemoglobin ≥ 9.0 g\u002FdL.\n   5. Total bilirubin ≤ 1.5 × upper limit of normal (ULN).\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.\n   7. Alkaline phosphatase ≤ 2.5 × ULN.\n   8. Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin.\n6. Patient has no active urinary tract infection (UTI) as confirmed by urine culture or urinalysis. Note: In case of a symptomatic UTI the patient will be treated with antibiotics and the instillation will be postponed until resolution. In the case of asymptomatic bacteriuria, the use of prophylactic antibiotics and postponement of treatment is at the discretion of the investigator.\n7. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for clinical study participants.\n\nFemale patients of childbearing potential (defined as premenopausal women who have not been sterilized) and male patients with female partners of childbearing potential must agree to use 2 acceptable forms of effective contraception from enrollment through 6 months post treatment. Sexually active male patients must agree to use a condom during intercourse for at least 48 hours after each instillation.\n\nAcceptable methods of birth control considered to have a low failure rate (ie, less than 1% per year) when used consistently and correctly include implants, injectable, combined (estrogen\u002Fprogesterone) oral contraceptives, intrauterine devices (only hormonal), condoms with spermicide, sexual abstinence\\* or vasectomized partner.\n\n\\* Sexual abstinence is defined as refraining from intercourse from enrollment through 6 months post treatment. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is NOT an acceptable method of contraception.\n\nExclusion Criteria:\n\n1. UC specific exclusions:\n\n   1. Patient received Bacillus Calmette-Guérin (BCG) treatment for UC during the 6 months before enrollment.\n   2. The patient has untreated concurrent UC in locations other than the target area (unless treated and resolved during Screening); ie, ureteral and lower urinary tract tumors must be completely ablated before entry.\n   3. Patient has a history of carcinoma in situ (CIS) in the urinary tract.\n   4. Patient has a history of invasive UC in the past 5 years.\n   5. Patient has a history of HG papillary UC in the urinary tract in the past 2 years.\n2. Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the study.\n3. Any other malignancy diagnosed within 2 years before enrollment with the exception of:\n\n   1. Basal or squamous cell skin cancers.\n   2. Noninvasive cancer of the cervix.\n   3. Any other cancer deemed to be of low risk for progression or patient morbidity during the study period in the opinion of the investigator.\n4. Patient with urinary obstruction such that there is an inability to deliver the study treatment to the pyelocalyceal system either via ureteral catheter (retrograde administration) or nephrostomy tube (antegrade administration).\n5. Known allergy or sensitivity to any component of the study treatment (including excipients) that in the investigator's opinion cannot be readily managed.\n6. Patient has an intractable bleeding disorder (eg, coagulation factors deficiencies, Von Willebrand disease).\n7. Patient is currently receiving any other investigational product, has participated in a research protocol involving administration of an investigational product in the past 30 days, or plans to participate in a research protocol involving administration of an investigational product during study conduct.\n8. Patient was previously treated with JELMYTO (product code UGN-101) for UTUC.\n9. Women who are pregnant (positive urine or serum pregnancy test), planning to become pregnant during the study period, or who are breastfeeding are not eligible to enroll.\n10. Patient has any other medical or mental condition(s) that make(s) his\u002Fher participation in the study unadvisable in the opinion of the investigator.\n11. Where applicable per country regulation, the patient must not be currently committed to an institution by virtue of an order issued by either judicial or administrative authorities.","ALL","18 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This study will evaluate the efficacy and safety of UGN-104, a new formulation of UGN-101 (approved in the United States and Israel as JELMYTO \\[mitomycin\\] for pyelocalyceal solution), instilled in the upper urinary tract (UUT) of patients with low-grade upper tract urothelial cancer (LG-UTUC).",[26,27],"Upper Urinary Tract Urothelial Carcinoma","Urothelial Carcinoma",[29,30,31,32,33,34,35,36],"UTUC","Low Grade UTUC","Low-grade Upper Tract Urothelial Cancer","UGN-104","Mitomycin","Nephrostomy Tube","LG-UTUC","UGN-101","RECRUITING","2026-06-12",{"date":40,"type":41},"2026-06-16","ACTUAL",{"date":43,"type":41},"2025-08-06",{"date":45,"type":20},"2028-03",{"name":47,"class":48},"UroGen Pharma Ltd.","INDUSTRY",62,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100637899","phase-2-hero-utuc-intravesical-rc48-after-rnu-for-her2-utuc-100637899","NCT07591805","HERO-UTUC: Intravesical RC48 After RNU for HER2+ UTUC","A Prospective Phase II Study of Single Postoperative Intravesical Disitamab Vedotin to Prevent Bladder Recurrence After Radical Nephroureterectomy in HER2-Positive Upper Tract Urothelial Carcinoma","HERO-UTUC","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically or radiologically suspected UTUC planned for RNU\n3. HER2-positive tumor defined as IHC 1+, 2+, or 3+ on preoperative or surgical specimen testing.\n4. ECOG performance status 0-1.\n5. No prior or concomitant bladder urothelial carcinoma within 5 years.\n6. Adequate hematologic, hepatic, and renal function.\n7. Ability to comply with protocol-required surveillance.\n8. Written informed consent. -\n\nExclusion Criteria:\n\n1.Evidence of metastatic disease before enrollment. 2.Prior treatment with disitamab vedotin. 3.Prior intravesical anti-cancer therapy within 12 months. 4.Active uncontrolled infection. 5.Pregnancy or breastfeeding. 6.Severe uncontrolled cardiovascular, pulmonary, hepatic, or systemic disease. 7.Known hypersensitivity to study drug components. 8.Any condition that, in the investigator's judgment, would compromise participation or interpretation.\n\n\\-","85 Years",{"count":60,"type":20},49,[62],"PHASE2","This is a prospective, single-center, single-arm phase II study evaluating whether a single postoperative intravesical instillation of disitamab vedotin (RC48) can reduce bladder recurrence after radical nephroureterectomy (RNU) in patients with HER2-positive upper tract urothelial carcinoma (UTUC). Eligible patients will receive one intravesical instillation of RC48 within 96 hours after surgery. The primary objective is to determine the 12-month intravesical recurrence rate. Serial urine samples will be prospectively collected to evaluate urinary methylation biomarkers for early recurrence detection.",[26],[26,66,67,68],"Bladder Recurrence","Disitamab Vedotin","Radical Nephroureterectomy","NOT_YET_RECRUITING","2026-05-15",{"date":72,"type":41},"2026-05-18",{"date":74,"type":20},"2026-05-16",{"date":76,"type":20},"2028-01-31",{"name":78,"class":79},"RenJi Hospital","OTHER",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100598896","the-danish-bladder-cancer-group-23-study---a-european-study-on-cancer-in-the-upper-urinary-tract-100598896","NCT07077447","The Danish Bladder Cancer Group 23 Study - A European Study on Cancer in the Upper Urinary Tract","DaBlaCa 23 - The European Collaborative Study on Upper Urinary Tract Urothelial Carcinoma","EuroCUT","Inclusion Criteria:\n\n* Patients with confirmed histopathology of UTUC\n* Age ≥ 18 years\n* Informed patient consent\n\nExclusion Criteria:\n\n* Patient not willing or able to give informed consent",{"count":90,"type":20},2500,"OBSERVATIONAL","This is a study looking at how patients with a rare type of cancer in the pelvis and ureter of the kidney - called upper urinary tract urothelial carcinoma (UTUC) - is currently treated. The gold standard treatment of UTUC is the complete removal of the kidney, renal pelvis and ureter. The use of kidney-sparing surgery, which preserves the kidney while treating the cancer, was only considered for patients who were too frail to undergo kidney removal, had a solitary functioning kidney, or suffered from severe chronic kidney disease. Since 2018 international guidelines have incorporated kidney sparing surgery for all patients but only offered to patients that have been diagnosed with very low risk tumors to ensure the safety of the patients. The latest update of the UTUC Guidelines from the European Association of Urology has revised the criteria, so that certain features previously classified as high-risk are no longer considered high-risk on their own, provided the tumor otherwise appears benign. Nonetheless, ongoing research is essential to support this evolving approach and to further enhance the guidelines.\n\nKidney sparing surgery comprise of a strict follow up schedule that often demands supplemental surgeries under general anesthesia, which can cause strain on patients.\n\nPreservation of the kidney is important since a decrease in kidney function can result in increased risk of cardiovascular disease and death.\n\nThe main question we want to answer is:\n\nCan more patients with superficial non-invasive UTUC safely be treated with kidney-sparing surgery instead of the more aggressive surgery that removes the entire kidney and ureter without increasing the risk of the cancer coming back and while maintaining quality of life? Furthermore, we are interested in learning more about patients who later develop bladder cancer after treatment of UTUC (intravesical recurrences), the affection of kidney function over time and a subgroup of UTUC patients that are diagnosed with Lynch syndrome (a genetic condition that increases cancer risk and development of UTUC is the third most common cancer) where UTUC presents differently than other patients.\n\nParticipants Anyone diagnosed with UTUC can take part in the study. We will collect information from their medical records when they join and again after one, three, five, and ten years. Participants will also be asked to fill out quality-of-life questionnaires at the beginning of entering the study and at one, three and five years.",[26],[29,26,95,96,97,98,99,100],"Kidney Sparing Surgery","Prospective cohort study","Ureteroscopy","Radical nephroureterectomy","Lynch Syndrome","Endoscopic management of UTUC","2025-12-15",{"date":103,"type":41},"2025-12-22",{"date":105,"type":41},"2025-11-26",{"date":107,"type":20},"2040-06-30",{"name":109,"class":79},"Zealand University Hospital",5,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":21,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":80},"100532260","phase-2-a-clinical-study-of-the-efficacy-and-safety-of-disitamab-vedotin-in-combination-with-radiotherapy-for-the-adjuvant-treatment-of-her2-overexpressing-utuc-patients-with-high-risk-factors-for-recurrence-after-radical-surgery-100532260","NCT06210490","A Clinical Study of the Efficacy and Safety of Disitamab Vedotin in Combination With Radiotherapy for the Adjuvant Treatment of HER2 Overexpressing UTUC Patients With High Risk Factors for Recurrence After Radical Surgery","Inclusion Criteria:\n\n1. Voluntary enrollment and signing of written informed consent;\n2. Age ≥ 18 years, male or female;\n3. Pathologically confirmed UTUC with at least any one of the following conditions: ① pT2 (need to be combined with at least simultaneous G3\u002Fhigh-grade tumor multiple, multifocal positive margins and one of the high-risk recurrence factors); ② pT3 to pT4; ③ pN+;\n4. Cisplatin intolerance or not receiving platinum-based drugs for adjuvant therapy;\n5. No recurrent metastasis confirmed by imaging ≥4 weeks postoperatively;\n6. HER2 immunohistochemistry (IHC) results of IHC 3+ or 2+, subject's previous test results (confirmed by the investigator), and study center results are acceptable;\n7. Expected survival time ≥ 6 months;\n8. Eastern Cooperative Oncology Group (ECOG) Physical Status (PS) score of 0 to 1;\n9. Normal major organ function, i.e., fulfillment of the following criteria:\n\n   * Routine blood tests (no blood transfusion and no G-CSF use within 14 days prior to screening): a) Hemoglobin ≥ 90 g\u002FL; b) Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL; c) Leukocyte count ≥ 3.0 × 10\\^9 \u002FL; d) Platelet count ≥ 80 × 10\\^9\u002FL ②Blood biochemistry (no albumin use within 14 days prior to screening): a) Albumin ≥ 28 g\u002FL; b) Total bilirubin ≤ 2 x upper limit of normal (ULN); c) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 x ULN in the absence of liver metastases, and ALT, AST, and ALP ≤ 5 x ULN in the presence of liver metastases; d) Creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 50 mL\u002Fmin calculated by the Cockcroft-Gault formula ③Coagulation: a) International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 x ULN; b) Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n\nExclusion Criteria:\n\n1. A history of malignancy other than uroepithelial carcinoma, except in the following two cases: a) The patient has received potentially curative therapy and has had no evidence of the disease for 5 years; b) Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the uterine cervix, and other carcinomas in situ for which resection was successfully received;\n2. Prior allogeneic stem cell or parenchymal organ transplantation;\n3. Patients who have received other prior anti-tumor systemic therapy (including herbal medicine with anti-tumor indications) less than 4 weeks after completion of therapy and prior to dosing in this study, or who have not recovered from adverse events caused by prior therapy to ≤ CTCAE grade 1 (with the exception of alopecia and hyperpigmentation);\n4. Prior or current congenital or acquired immunodeficiency disease;\n5. Active or previously documented autoimmune or inflammatory diseases (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, pituitary gland inflammation, hyper- or hypothyroidism, and asthma requiring bronchodilator therapy), with vitiligo, or asthma that has resolved completely in childhood and does not require any intervention in adulthood;\n6. Treatment with systemic immunosuppressive medication within 2 weeks prior to enrollment or anticipated need for systemic immunosuppressive medication during the study period, with the exception of the following: a) Intranasal, inhaled, topical, or locally injected (e.g., intra-articular injection) corticosteroids; b) Systemic corticosteroids in doses not exceeding 10 mg\u002Fday of prednisone or other equivalent effect; c) Prophylactic corticosteroids for hypersensitivity reactions;\n7. Patients with a known or suspected history of hypersensitivity to vedicilumab and similar drugs, or a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or to excipients of the study drug;\n8. Prior thrombosis or thromboembolic event within the previous 6 months, such as stroke and\u002For transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc;\n9. Patients assessed by a physician to be at risk for severe bleeding, including but not limited to severe bleeding (\\> 30 ml within 3 months), hemoptysis (\\> 5 ml within 4 weeks), with gastroscopy\u002Fassessment in the event of any of the above, whichever is based on the microscopic assessment or active bleeding or coagulation abnormality, with a propensity to hemorrhage or undergoing thrombolytic, anticoagulant, or antiplatelet therapy;\n10. clinically significant cardiovascular disease including, but not limited to, acute myocardial infarction, severe\u002Funstable angina or coronary artery bypass grafting within the previous 6 months, congestive heart failure (New York Heart Association NYHA classification \\> grade 2), arrhythmias that are poorly controlled or require pacemaker therapy, hypertension that is uncontrolled by medications (systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg);\n11. Other significant clinical and laboratory abnormalities that, in the opinion of the investigator, compromise the safety evaluation, e.g., uncontrolled diabetes mellitus, chronic kidney disease, grade II or greater peripheral neuropathy (CTCAE V5.0), abnormal thyroid function;\n12. Serious infections that are active or poorly controlled clinically active infections, including: a) Positive for the AIDS virus (HIV) (HIV1\u002F2 antibodies); b) Active Hepatitis B (HBsAg positive or HBV DNA \\> 2000 IU\u002Fml and abnormal liver function); c) Active hepatitis C (HCV antibody positive or HCV RNA ≥103 copies\u002Fml and abnormal liver function); d) Active tuberculosis; e) Other uncontrolled active infection (CTCAE V5.0 \\> grade 2);\n13. Not yet recovered from surgery, e.g. presence of unhealed incisions or serious postoperative complications;\n14. Women who are pregnant or breastfeeding, and female or male patients of childbearing potential who are unwilling or unable to use effective contraception;\n15. other conditions that the investigator deems inappropriate for inclusion.",{"count":118,"type":20},60,[62],"In this study, 60 patients with HER2 overexpression UTUC with high-risk recurrence factors after radical surgery were proposed to be enrolled, and were assigned to Cohort I (receiving adjuvant therapy group) and Cohort II (refusing to receive adjuvant therapy group) according to the subjects' wishes. Cohort I subjects were treated with vedicloxacinumab in combination with radiotherapy, and vedicloxacinumab treatment lasted for 6 months. Cohort II subjects receive close observation and best supportive care. Safety evaluations and efficacy evaluations will be performed during the study period. Safety Evaluations: Safety evaluations will be conducted within 3 days prior to each dose and will continue until 30 days after the last study dose or initiation of new antitumor therapy for subjects who have received at least one dose of study drug. Evaluation of effectiveness: effectiveness evaluations will be conducted every 12 weeks (±3 days) until imaging-confirmed tumor recurrence, subject death, withdrawal of informed consent, loss to follow-up, or study termination, whichever occurs first. Tumor assessment was performed according to the Criteria for Evaluation of Efficacy in Solid Tumors (RECIST v1.1). For subjects with disease progression, postoperative tumor recurrence, or initiation of other antitumor therapy, survival follow-up was performed every 3 months (window period ± 14 days) from the date of notification to collect information on the subject's subsequent antitumor therapy and survival until the subject's death, withdrawal of informed consent, loss of visit, or study termination, whichever occurred first.",[26],"2025-12-07",{"date":101,"type":41},{"date":125,"type":41},"2024-02-20",{"date":127,"type":20},"2028-05-31",{"name":129,"class":79},"Peking University First Hospital",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":21,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":80},"100509391","phase-2-combination-of-dv-and-tislelizumab-for-renal-preservation-in-high-risk-utuc-patients-100509391","NCT05912816","Combination of DV and Tislelizumab for Renal Preservation in High-risk UTUC Patients","Perioperative Disitamab Vedotin and Tislelizumab Followed by Nephron-Sparing Surgery in High-Risk Upper Tract Urothelial Carcinoma: A Phase 2 Trial (DISTINCT-I)","Inclusion Criteria:\n\n1. ECOG 0\\~2;\n2. HER-2 IHC 0-3+;\n3. Subjects underwent cystoscopic\u002Fureteroscopic biopsy, exfoliation cytology, and CT\u002FMRI diagnosis;\n4. Patients were judged to be high-risk urothelial carcinoma of the upper urinary tract (meeting any of the following risk factors: hydronephrosis, tumor diameter ≥2cm, high-grade, multiple tumors in cytology, previous history of radical cystectomy for high-grade bladder cancer, biopsy pathology with other tissue components);\n5. High-risk UTUC(excluding low-risk UTUC),including renal pelvic tumors (cT1-T3, N0) or ureteral tumors (cT1-T3, N0-N1) M0;\n6. Patients with indications of absolute or relative renal protection (only kidney, renal insufficiency: eGFR \\\u003C 60 ml\u002Fmin)\n7. Have the desire to protect the kidney;\n8. There is no indication of absolute or relative kidney preservation, but patients have a strong desire to preserve kidney.\n9. Has and agrees to provide cystoscopic\u002Fureteroscopic biopsy tissue specimens and to reserve pre-treatment blood,\n10. Urine and biopsied biological samples;\n11. Predicted survival ≥3 months;\n12. Major organ function is normal (14 days prior to enrollment)\n13. International Normalized ratio (INR), activated partial thromboplastin time (aPTT) : ≤1.5× ULN (This criterion only applies to patients who are not receiving anticoagulant therapy; Patients receiving anticoagulant therapy should keep anticoagulants within therapeutic limits);\n14. Did not receive systemic corticosteroid medication within 4 weeks prior to treatment;\n15. Fertile men or women who are at risk of becoming pregnant must use a highly effective contraceptive method during the trial (such as oral contraceptives, intrauterine devices, controlled sexual desire or barrier contraception combined with spermicide) and continue using contraception for 12 months after the end of treatment;\n16. The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n1. Previously received anti-PD-1, anti-PD-L1, anti-PD-L2 therapy, including adjuvant therapy stage;\n2. Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components;\n3. Had received other antitumor therapy (including corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks prior to the study treatment, or had not recovered from the previous toxicity (except for 2 degrees of hair loss and 1 degree of neurotoxicity);\n4. Pregnant or lactating women;\n5. Positive HIV test result;\n6. People with active hepatitis B or C\n7. HBsAg or HBcAb positive patients also detected HBV DNA copy number positive (quantitative detection limit is 500IU\u002Fml, or reach the positive value of the study center); Screening studies of such patients must test for HBV DNA;\n8. Patients who tested positive for HCV antibodies were enrolled in this study only if the PCR results of HCV RNA were negative.\n9. A clear history of active tuberculosis;\n10. Have active autoimmune diseases that have required systemic treatment within the past 2 years (e.g., with disease-regulating drugs, corticosteroids, or immunosuppressive drugs) that allow for relevant replacement therapy (e.g., thyroxine, pancreatic hormone, or physiologic corticosteroid replacement therapy for renal or pituitary insufficiency);\n11. Other serious, uncontrolled concomitant diseases that may affect protocol adherence or interfere with interpretation of results, These include active opportunistic or progressive (severe) infections, uncontrolled diabetes, cardiovascular disease (heart failure of Grade Ⅲ or Ⅳ as defined by the New York Heart Association scale, heart block above grade Ⅱ, myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc.) Or pulmonary disease (history of interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm);\n12. Received live vaccine within 4 weeks prior to the start of treatment;\n13. Have previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;\n14. Major surgical procedures (excluding diagnostic surgery) within 4 weeks prior to the start of treatment; Those who have a history of psychotropic drug abuse and cannot abstain or have a history of mental disorders;\n15. A large amount of pleural effusion or ascites accompanied by clinical symptoms or requiring symptomatic treatment;\n16. Have had other unhealed malignancies in the past 5 years, excluding those that are apparently cured or curable, such as basal or squamous cell skin cancer, localized low-risk prostate cancer, carcinoma in situ of the cervix or carcinoma in situ of the breast; Remarks: Patients with localized low-risk prostate cancer (defined as stage ≤T2a, Gleason score ≤6, and PSA≤10ng\u002FmL at the time of prostate cancer diagnosis (as measured) who had received radical therapy and had no biochemical recurrence of prostate specific antigen (PSA) were eligible to participate in this study);\n17. Bladder cancer (MIBC);\n18. Other severe, acute, or chronic medical or psychiatric conditions or laboratory abnormalities that, according to the investigator, may increase the risks associated with study participation or may interfere with the interpretation of the study results.","90 Years",{"count":139,"type":20},20,[62],"This is a prospective, open, multiple-center clinical study of renal preservation therapy in high-risk upper urinary tract urothelial carcinoma patients . The study was conducted in accordance with the Good Practice for Quality Control of Clinical Trials for Pharmaceutical Products (GCP). Approximately 20 subjects will be enrolled to evaluate the efficacy and safety of RC48 (2.0 mg\u002Fkg intravenously every 3 weeks) combined with Tislelizumab (200mg intravenously every 3 weeks).",[26,143,144,145],"Kidney Preservation","HER-2 ADC","PD-1antibody","2025-12-02",{"date":148,"type":41},"2025-12-09",{"date":150,"type":41},"2023-06-10",{"date":152,"type":20},"2026-12-30",{"name":78,"class":79},{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":173,"locationsCount":80},"100543312","phase-2-dv-combined-with-toripalimab-for-renal-preservation-in-solitary-kidney-or-renal-insufficiency-or-bilateral-multiple-utuc-100543312","NCT06354231","DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC","A Prospective, Open-label, Single-arm, Clinical Study of Disitamab Vedotin Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple Upper Urinary Tract Urothelial Carcinoma","Inclusion Criteria:\n\n* ≥18 years old;\n* Histologically confirmed isolated renal or renal insufficiency or bilateral upper urinary tract urothelial carcinoma;\n* Refusal or ineligibility for RNU;\n* Preoperative risk stratification was defined as high-risk UTUC, defined as patients with any of the following factors:\n\n  1. Hydronephrosis;\n  2. Tumor diameter ≥2cm;\n  3. Urine cytology suggests a high-grade tumor;\n  4. A ureteroscopic biopsy suggests a high-grade tumor;\n  5. CT showed a localized invasion;\n  6. Multifoci diseases;\n  7. With multiple histological subtypes;\n* ECOG 0\\~1;\n* Major organ function is normal (14 days prior to enrollment) if the following criteria are met:\n\n  1. The blood routine examination criteria should meet (no blood transfusion and no granulocyte colony stimulation agent treatment within 14 days before enrollment): HB≥90 g\u002FL; ANC≥1.5×109 \u002FL; PLT≥100×109 \u002FL;\n  2. Non-functional organic diseases shall meet the following criteria: T-BIL≤1.5×ULN (upper limit of normal value); ALT and AST≤2.5 x ULN; Serum creatinine ≤2×ULN, or endogenous creatinine clearance ≥ 30ml\u002Fmin(Cockcroft-Gault formula);\n* Subjects (or their legal representatives) must sign an informed consent form (ICF) indicating that they understand the purpose and procedures of the study and are willing to participate in the study.\n* Pregnant women must have a negative pregnancy test result (beta-hCG) (urine or serum) within 7 days before the first administration of the randomized or study drug.\n\nExclusion Criteria:\n\n* Histopathological examination revealed any small cell component of ureter or pelvis, simple adenocarcinoma, simple squamous cell carcinoma, or simple squamous CIS;\n* Previous treatment with other PD-1\u002FPD-L1 inhibitors and\u002For HER-2 inhibitors;\n* Active malignancies other than the disease being studied for treatment (i.e., disease progression within the last 24 months or requiring a change in treatment), only the following special cases are allowed: i. Skin cancer that has been treated within the last 24 months and has been completely cured ii. Adequately treated lobular carcinoma in situ (LCIS) and ductus CIS iii. History of local breast cancer and is receiving antihormonal drugs or history of local prostate cancer (N0M0) and is receiving androgen blocking therapy;\n* History of uncontrolled cardiovascular disease, including: 1) any of the following in the past 3 months: unstable angina pectoris, myocardial infarction, ventricular fibrillation, torsion ventricular tachycardia, cardiac arrest, or known congestive New York Heart Association Class III-IV heart failure, cerebrovascular accident, or transient ischemic attack; 2) QTc interval prolongation confirmed by ECG evaluation at screening (Fridericia; QTc \\> 480 ms); 3) Pulmonary embolism or other venous thromboembolism within the past 2 months;\n* Pregnant or lactating women;\n* Human immunodeficiency virus (HIV) infection is known unless the subject has been on stable antiretroviral therapy for the past 6 months or longer, has not developed an opportunistic infection in the past 6 months, and has a CD4 count \\> 350 in the past 6 months.\n* Known history of clinically significant liver disease, including viral hepatitis \\[active HBV infection, i.e., HBV DNA positive (\\>1×104 copies \u002FmL or \\>2000 IU\u002Fml) must be excluded for known hepatitis B virus (HBV) carriers; Known hepatitis C virus infection (HCV) and HCV RNA positive (\\>1×103 copies \u002FmL), or other hepatitis, cirrhosis\\];\n* Have not recovered from the toxic effects of previous anticancer treatment (except for those that are not clinically significant, such as hair loss, skin discoloration, neuropathy, and hearing impairment);\n* Delayed wound healing, defined as skin\u002Fbedsore ulcers, chronic leg ulcers, known stomach ulcers, or non-healing of incisions;\n* Major surgery within 4 weeks before day 1 of Cycle 1 (TURBT is not considered a major surgery);\n* Other patients assessed by the investigator as unsuitable for participation in the study.",{"count":139,"type":20},[62],"Approximately 20 participants will be enrolled in the study to evaluate the efficacy and safety of the combination of DV (DV, 2.0 mg\u002Fkg, intravenously administered every 2 weeks) and toripalimab (toripalimab, 3.0mg\u002Fkg, intravenously administered every 2 weeks). Subjects will receive 6 cycles of DV and toripalimab, followed by laser surgery to remove ureteral or renal pelvis tumors, followed by 12 cycles of DV and 1 year of toripalimab consolidation therapy. Efficacy and safety were evaluated by cystoscopy, ureteroscopy, laboratory tests, and imaging examinations after treatment.",[165,26,166],"Renal Insufficiency","Solitary Kidney","2024-04-09",{"date":169,"type":41},"2024-04-11",{"date":171,"type":41},"2023-07-20",{"date":152,"type":20},{"name":174,"class":79},"Fudan University",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":184,"conditions":185,"keywords":186,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":80},"100529104","translational-cancer-observational-protocol-100529104","NCT06169436","Translational Cancer Observational Protocol","2014 Transizionali - Observational Study on the Occurrence of Relapses and on the Quality of Life in Patients Who Underwent Nephroureterectomy Surgery","Inclusion Criteria:\n\n* 18 years or older\n* Upper tract urothelial cancer diagnosis\n* Indication to cancer removal through nephroureterectomy surgery\n* Ability to read and sign the informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Absence of upper tract urothelial cancer\n* Inability to read and sign the informed consent",{"count":183,"type":20},1250,"Observational study on relapse occurrence and on the quality of life in patients who underwent nephroureterectomy surgery",[26],[26,187,188,189,190],"Nephroureterectomy surgery","Relapse","Quality of life","Diagnosis and Treatment strategies","2023-12-05",{"date":193,"type":41},"2023-12-13",{"date":195,"type":41},"2014-07-17",{"date":197,"type":20},"2064-07-17",{"name":199,"class":79},"IRCCS San Raffaele",{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":208,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":21,"phases":211,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":228},"100501543","phase-3-single-dose-intravesical-chemotherapy-after-diagnostic-urs-100501543","NCT05810623","Single-Dose Intravesical Chemotherapy After Diagnostic URS","Single-Dose Intravesical Instillation of Chemotherapy After Diagnostic\u002FTherapeutic Flexible Ureteroscopy for Upper Tract Urothelial Carcinoma in the Prevention of Intravesical Recurrence: Prospective Randomized Multicenter Trial","MINERVA","Inclusion Criteria:\n\nSubjects must meet all the following inclusion criteria to participate in this study:\n\n* Age ≥ 18 years\n* Diagnosis primary localized UTUC\n* Imaging examinations show no distant metastasis\n* Patients who agree to receive SI after URS for UTUC and will undergo the standard treatment, postoperative management, and follow-up in accordance with current guidelines\n\nExclusion Criteria:\n\n* Any concurrent systemic therapy for any cancer\n* Prior bladder cancer within 5 years\n* Prior radical cystectomy\n* Concomitant bladder cancer\n* Bilateral UTUC\n* Pregnancy\n* Patient refused to participate\n* Life expectancy of less than one year\n* Solitary kidney",true,{"count":210,"type":20},394,[23],"Study design This study is a Phase III, randomized, open-label, multi-center, global study to determine the efficacy of a single immediate intravesical chemotherapy instillation (SI) in the prophylaxis of intravesical recurrence after diagnostic uretero-renoscopy (URS) of patients 18 years of age or older with the fist diagnosis of UTUC.\n\nThis study will randomize 394 patients globally Patients will be randomized in a 1:1 ratio to the interventional arm or to observation.\n\nStudy period This study will include a screening period, a treatment and disease assessment period, safety follow-up visits and a 5-year survival follow-up period to begin immediately after the treatment.\n\nScreening period: The period up to 28 days prior to intervention during which the screening procedures occur.\n\nTreatment and disease assessment period: The period starting the day of diagnostic URS (Day 0) during which patients receive their assigned treatment (Day 0 to day 1) and disease assessments are performed. All patients must follow the disease assessment schedule, which includes disease assessments at screening and every 3 months (±1 week) from the date of intervention until 24 months from the date of randomization, and then every 6 months for up to 5 years. The treatment and disease assessment period will end at the time of intravesical recurrence, death, or MINERVA-CTU decision to terminate the trial early.\n\nSafety follow-up visits: Every patient in this study will be assessed for the occurrence of adverse events (AEs) and serious adverse events from the time of signed informed consent until 90 days after the administration of SI. All patients who receive SI will have safety visits 4, 8, and 12 weeks following administration of SI. Safety assessments include targeted physical examination, complications according to Dindo-Clavien classification and patient-reported outcomes (PRO) assessments.\n\nSurvival follow-up period: Patients will be followed up at in-clinic site visits, by telephone contact, or by contact with the patient's current physician for up to 5 years from the date of randomized into this study.\n\nObjectives Primary objective Efficacy of a SI in the prophylaxis of intravesical recurrence after diagnostic URS for UTUC\n\nSecondary objectives\n\n* Time to intravesical recurrence\n* 5-years intravesical recurrence rates\n* Incidence of high-grade BCa recurrence\n* Incidence and gravity of adverse events (AEs) due to the SI\n* To collect and store blood, urine and tissue samples according to each country's local and ethical procedures for identifying candidate markers that may correlate with likelihood of clinical benefit (optional)\n* To collect and store DNA according to each country's local and ethical procedures for future exploratory research into somatic mutations and genes\u002Fgenetic variations that may influence oncologic outcomes, to study treatments and susceptibility to disease (optional)\n* To assess disease-related symptoms and HRQoL in patients with UTUC treated with SI compared those undergoing observation\n* To assess patient-reported treatment tolerability directly using specific PRO-CTCAE symptoms\n\nTarget study population The study population includes patients 18 years of age or older with a primary diagnosis of UTUC, scheduled for diagnostic URS\n\nDuration of treatment Patients randomized to the interventional arm will receive a SI within 24h after diagnostic URS. In case of multiple diagnostic URS during the follow-up (including 2nd look for incomplete ablation, non-diagnostic first URS or UTUC recurrence) patients randomized to the interventional arm will receive a SI after each diagnostic URS for 2 years after the day of first diagnostic URS.\n\nFollow-up of subjects post discontinuation of study treatment Patients who have discontinued study treatment due to toxicity, symptomatic deterioration, intravesical recurrence or investigator's decision will be followed up for survival until 5 years from the date of diagnostic URS.\n\nSurvival All randomized patients, regardless of disease status, will be followed up for survival until 5 years from the date of diagnostic URS.\n\nInvestigational product, dosage, and mode of administration Patients randomized to the interventional arm will receive a SI. The chemotherapy will be at investigator's discretion and institutional availability.\n\nThe selected chemotherapy must be approved by the MINERVA-CTU in discussion with the local investigator.\n\nStatistical methods This study will randomize 394 patients globally. Patients will be randomized 1:1 to SI or observation.\n\nRandomization will be stratified by the following factors:\n\n1. Center\n2. EAU UTUC risk stratification",[26,214],"Bladder Cancer",[29,216,217,218],"intravesical chemotherapy","bladder cancer","recurrence","2023-03-31",{"date":221,"type":41},"2023-04-12",{"date":223,"type":20},"2023-06-01",{"date":225,"type":20},"2026-12-31",{"name":227,"class":79},"David D'Andrea",2]