[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urinary-bladder-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urinary-bladder-neoplasms":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,47,92,115,131,143,165,193,225,253,276,324,347,377,405,437,466,494,520,557,583,618,644,671],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053764","phase-3-a-study-of-vepugratinib-ly3866288-in-participants-with-cancer-in-the-urinary-tract-100053764",false,"NCT07218380","A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract","FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab in Adults With Untreated Locally Advanced or Metastatic Urothelial Carcinoma With an FGFR3 Genetic Alteration","FORAGER-2","Inclusion Criteria:\n\n* Have histologically confirmed, unresectable locally advanced or metastatic urothelial cancer (mUC). Individuals with mixed histology other than small cell or neuroendocrine carcinoma are eligible if a urothelial component is present.\n* Have a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration determined via molecular testing from a tumor or blood sample obtained at or any time after diagnosis of advanced or metastatic urothelial cancer.\n* Have measurable disease by investigator assessment defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Have adequate laboratory parameters\n\nExclusion Criteria:\n\n* Have received prior systemic therapy for locally advanced or metastatic urothelial cancer (mUC).\n* Have any unresolved toxicities greater than Grade 1 Common Terminology Criteria for Adverse Events (\\[CTCAE\\] version 5.0) from prior neoadjuvant or adjuvant systemic therapy.\n* Have ongoing sensory or motor neuropathy of Grade 2 or higher\n* Have untreated or uncontrolled central nervous system (CNS) involvement or any history of leptomeningeal disease.\n* Current evidence corneal keratopathy or retinal disorder confirmed by ocular examination at screening.","ALL","18 Years",{"count":20,"type":21},450,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to test a new medicine, vepugratinib, in comparison with placebo, to see if it is safe and can help people with a bladder cancer that is advanced or has spread.\n\nVepugratinib or placebo will be administered in combination with enfortumab vedotin and pembrolizumab.\n\nStudy participation could last up to approximately 6 years.",[27,28,29],"Carcinoma, Transitional Cell","Urinary Bladder Neoplasms","Neoplasm Metastasis",[31,32,33],"FGFR3","Advanced Urothelial Carcinoma","Metastatic Urothelial Carcinoma","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2025-12-12",{"date":42,"type":21},"2033-05",{"name":44,"class":45},"Eli Lilly and Company","INDUSTRY",286,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100636474","phase-3-enfortumab-vedotin-in-combination-with-pembrolizumab-vs-concurrent-chemoradiotherapy-ccrt-in-people-with-muscle-invasive-bladder-cancer-ev-309-100636474","NCT07566156","Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)","A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE ENFORTUMAB VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB IN ADULT PARTICIPANTS WITH MUSCLE-INVASIVE BLADDER CANCER WHO ARE INELIGIBLE FOR OR HAVE ELECTED NOT TO UNDERGO CYSTECTOMY","Inclusion Criteria:\n\n* Has histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology staged cT2-T4aN0M0\n* Tissue comprising muscle-invasive urothelial cancer must be submitted for clinical staging at baseline\n* Eligible for and agree to receive chemoradiotherapy and one of the protocol-specified radiosensitizing chemotherapy regimens\n* Fit for systemic therapy and elect bladder preservation, including participants who are ineligible for or have elected not to undergo cystectomy\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n\nExclusion Criteria:\n\n* Advanced or metastatic disease (N+, M1), non-urothelial carcinoma, diffuse or multifocal CIS, urothelial carcinoma or histological variant at any site outside the urinary bladder within previous 24 months prior to randomization except Ta\u002FT1\u002FCIS of the upper urinary tract including renal pelvis and ureter if the participant had undergone complete nephrectomy\n* Has received any prior systemic treatment, chemoradiation, and\u002For radiation for MIBC or NMIBC\n* Prior pelvic radiation for any reason\n* Inadequate bladder function\n* Other active malignancies within 3 years prior to randomization\n* Previously treated with enfortumab vedotin or other MMAE-based antibody-drug conjugates (ADCs)\n* Previously treated with a PD(L)-1 inhibitor, defined as a PD-1 inhibitor or PD-L1 inhibitor\n* Uncontrolled diabetes\n* Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of randomization. Routine antimicrobial prophylaxis is permitted\n* Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection\n* Received major surgery (defined as requiring general anesthesia and \\>24 hour inpatient hospitalization) within 4 weeks prior to randomization\n* Known severe (≥ Grade 3) hypersensitivity to any enfortumab vedotin excipient contained in the drug formulation of enfortumab vedotin\n* Known genetic disorders associated with radiosensitivity (eg, ataxia telangiectasia, Nijmegen breakage syndrome, Fanconi syndrome)\n* Active keratitis or corneal ulcerations\n* History of autoimmune disease that has required systemic treatment in the past 2 years\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n* Prior allogeneic stem cell or solid organ transplant\n* Received a live attenuated vaccine within 30 days prior to randomization",{"count":55,"type":21},390,[24],"This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together as a bladder preservation approach to treat patients with muscle invasive bladder cancer. The study will compare these drugs to concurrent chemoradiotherapy that is usually used to treat this cancer (standard of care). The study will enroll patients with muscle-invasive bladder cancer (MIBC) who have cancer that has not spread outside the bladder.",[59,28],"Urothelial Cancer",[61,62,63,64,65,66,67,68,69,70,71,28,72,73,74,75,76,77,78,59,79,80,81],"Urologic Neoplasms","Urogenital Neoplasms","Neoplasms by Site","Neoplasms","Female Urogenital Diseases","Female Urogenital Diseases and Pregnancy","Complications","Urogenital Diseases","Urinary Bladder Diseases","Urologic Diseases","Male Urogenital Diseases","Cisplatin","Fluorouracil","Mitomycin","Gemcitabine","Muscle Invasive Bladder Cancer","Enfortumab vedotin","Pembrolizumab","Urothelial Carcinoma","Bladder-sparing","Bladder Preservation","2026-07-01",{"date":84,"type":38},"2026-07-02",{"date":86,"type":38},"2026-05-11",{"date":88,"type":21},"2032-02-29",{"name":90,"class":45},"Astellas Pharma Global Development, Inc.",11,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100580113","phase-2-a-clinical-study-of-intismeran-autogene-v940-and-bcg-in-people-with-bladder-cancer-v940-011interpath-011-100580113","NCT06833073","A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011\u002FINTerpath-011)","A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n\\- Is an individual whose most recent TURBT was performed within 12 weeks before randomization\u002Fallocation and showed BICR-confirmed high-risk NMIBC histology\n\nCohort A:\n\n* Has high-risk non-muscle invasive (HG Ta, T1, and\u002For CIS) UC of the bladder\n* Is BCG-naïve defined as either having never received BCG or having received BCG more than 2 years before high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post BCG\n\nCohort B:\n\n* Has CIS +\u002F-papillary non-muscle invasive UC of the bladder\n* Is ineligible for, or refusing, any IVESIC therapy\n* Is either BCG-naïve (as defined above) or BCG-exposed but did not receive protocol-specified minimum dosing of BCG and experienced recurrence of high-risk NMIBC within 2 years of the last dose of BCG\n* Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a history of or concurrent locally-advanced (ie, T2, T3, T4) or metastatic UC\n* Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or a history of extravesical non-muscle invasive UC that recurred within the last 2 years, with certain exceptions\n* Has a known additional malignancy that is progressing or has required active treatment within the last 3 years\n* Has had a myocardial infarction within 6 months of randomization\u002Fallocation\n* Has received any systemic anticancer therapy including investigational agents within 4 weeks before randomization\u002Fallocation\n* Has received prior treatment with a cancer vaccine\n* Has immunodeficiency or is receiving chronic systemic steroid therapy\n* Has active autoimmune disease that has required systemic treatment in the last 2 years\n* Has any contraindication to IV contrast and gadolinium or is otherwise unable to have imaging with either computerized tomography urogram (CTU) or Magnetic resonance urography (MRU)\n\nCohort A:\n\n* Has current active tuberculosis\n* Has a known history of HIV infection\n\nCohort B:\n\n\\- HIV-infected individuals with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease",{"count":100,"type":21},308,[102],"PHASE2","Researchers are looking for new ways to treat people with high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment. HR NMIBC can also include carcinoma in situ (CIS). CIS is bladder cancer that appears flat and is only in the inner layer (surface) of the bladder. CIS is not raised and is not growing toward the center of the bladder.\n\nThe standard treatment for HR NMIBC is a procedure to remove the tumor called transurethral resection of the bladder tumor (TURBT) followed by Bacillus Calmette-Guerin (BCG). Standard treatment is something that is considered the first line of treatment for a condition. BCG is an immunotherapy, which is a treatment that helps the immune system fight cancer. However, BCG may not work to treat HR NMIBC in some people. Researchers want to learn if adding intismeran autogene, the study treatment, to standard treatment can help treat HR NMIBC. Intismeran autogene is designed to help a person's immune system attack their specific cancer.\n\nThe goal of this study are to learn if people who receive V940 with BCG live longer and without the cancer growing, spreading, or coming back compared to people who receive BCG alone.",[28,105,106],"Non-Muscle Invasive Bladder Neoplasms","Carcinoma in Situ",{"date":84,"type":38},{"date":109,"type":38},"2025-03-11",{"date":111,"type":21},"2031-09-03",{"name":113,"class":45},"Merck Sharp & Dohme LLC",89,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":130,"locationsCount":4},"100644897","expanded-access-for-vepugratinib-ly3866288-in-participants-with-fibroblast-growth-factor-receptor-3-fgfr3-altered-solid-tumors-100644897","NCT07675057","Expanded Access for Vepugratinib (LY3866288) in Participants With Fibroblast Growth Factor Receptor 3 (FGFR3) Altered Solid Tumors","Expanded Access for Vepugratinib in Participants With Fibroblast Growth Factor Receptor 3 (FGFR3) Altered Solid Tumors","Inclusion Criteria:\n\n* Have metastatic urothelial carcinoma (UC) or other solid tumor with a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration.\n* Have exhausted other approved treatments, including erdafitinib for UC.\n* Are not eligible for an ongoing vepugratinib clinical trial\n\nExclusion Criteria:\n\n* Currently enrolled in an ongoing clinical study of vepugratinib\n* Have a known severe (greater than or equal to (≥) Grade 3) hypersensitivity to any component or excipient of vepugratinib.\n* Current evidence of corneal keratopathy or retinal disorder confirmed by ocular examination. Exception: Individuals with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk.\n* Significant cardiovascular disease:\n* Are pregnant, breastfeeding, or intent to become pregnant during the study or within 6 months of the last dose of study intervention.","EXPANDED_ACCESS","The treating physician\u002Finvestigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.",[28,29,27],[33],"AVAILABLE","2026-06-23",{"date":129,"type":38},"2026-06-30",{"name":44,"class":45},{"id":132,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":25,"conditions":135,"keywords":136,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":140,"leadSponsor":141,"locationsCount":142},"100609730",{"count":20,"type":21},[24],[27,28,29],[31,32,33],"2026-06-19",{"date":127,"type":38},{"date":40,"type":38},{"date":42,"type":21},{"name":44,"class":45},284,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},"100610046","phase-1-a-clinical-study-of-mk-3120-in-people-with-bladder-cancer-mk-3120-003-100610046","NCT07222488","A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)","Phase 1\u002F2 Study of Intravesical MK-3120 in BCG-Naïve or BCG-Exposed High-Risk Non-muscle Invasive Bladder Cancer","Inclusion Criteria:\n\n* Has histologically confirmed carcinoma in situ (CIS) +\u002F- papillary high-risk non-muscle invasive bladder cancer (NMIBC), confirmed locally.\n* Is an individual whose most recent transurethral resection of bladder tumor (TURBT) was performed within 12 weeks before allocation and showed high-risk NMIBC histology. For individuals with papillary tumors (Ta and T1), a complete TURBT must have been performed, as characterized by attainment of a visually complete resection of all papillary tumors (Ta and T1).\n* Is either: a) Bacillus Calmette-Guérin (BCG)-naïve, defined as either having never received BCG or having received BCG more than 2 years before CIS +\u002F- papillary high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post-BCG OR; b) BCG-exposed and received adequate BCG therapy and had recurrence of CIS +\u002F- papillary high-risk NMIBC \\>12 months but ≤24 months after the last BCG dose.\n* Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy.\n* Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation.\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n\nExclusion Criteria:\n\n* Has history of or current locally advanced (ie, T2, T3, T4) or metastatic urothelial cancer (UC).\n* Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or history of extravesical non-muscle invasive UC that recurred within the last 2 years.\n* Has active total bladder incontinence, active urinary tract infection, neurogenic bladder, or urethral stricture.\n* Has a condition that would prohibit normal voiding (or holding bladder voiding for 1 to 2 hours).\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>470 ms, and\u002For other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing.\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has active infection requiring systemic therapy.\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids, or has current pneumonitis\u002FILD.\n* Has not adequately recovered from major surgery or has ongoing surgical complications.",{"count":151,"type":21},45,[153,102],"PHASE1","Researchers are looking for new ways to treat high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder and has not spread to the bladder muscle or outside of the bladder. In standard treatment for HR NMIBC, doctors first remove the tumor with a procedure called transurethral resection of the bladder tumor (TURBT). Researchers want to learn if using MK-3120, the study medicine, can treat HR NMIBC after TURBT. The goal of this study is to learn about the safety of MK-3120 and if people tolerate it.",[156,28],"Bladder Cancer","2026-06-18",{"date":127,"type":38},{"date":160,"type":38},"2025-12-09",{"date":162,"type":21},"2029-02-28",{"name":113,"class":45},14,{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},"100486489","phase-1-forager-1-a-study-of-loxo-435-ly3866288-in-participants-with-cancer-with-a-change-in-a-gene-called-fgfr3-100486489","NCT05614739","FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3","FORAGER-1: A Phase 1, Open-Label, Multicenter Study of LOXO-435 (LY3866288) in Locally Advanced or Metastatic Solid Tumors Including Urothelial Cancer With FGFR3 Alterations","FORAGER-1","Inclusion Criteria:\n\n* Have solid tumor cancer with an FGFR3 pathway alteration on molecular testing in tumor or blood sample that is deemed as actionable\n\n  * Cohort A1: Presence of an alteration in FGFR3 or its ligands\n  * Cohort A2, B2, B3, and B5: Histological diagnosis of urothelial cancer (UC) that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration\n  * Cohorts B1 and B4: Histological diagnosis of urothelial cancer that is locally advanced or metastatic\n  * Cohort C1: Must have histological diagnosis of a non-urothelial solid tumor malignancy that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration\n* Measurability of disease:\n\n  * Cohort A1 and B3: Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v1.1)\n  * Cohorts A2, B1, B2, B4, B5, and C1: Measurable disease required as defined by RECIST v1.1\n* Have adequate tumor tissue sample available. Participants with inadequate tissue sample availability may still be considered for enrollment upon review\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for Cohorts A1, A2, B3, and B5\n\n  * Less than or equal to 2 for Cohorts B1, B2, B4, and C1\n* Prior Systemic Therapy Criteria:\n\n  * Cohort A1\u002FC1: Participant has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating Investigator; OR the participant is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies.\n  * Cohort A2, B2, B3 participants must have received at least one prior regimen, and cohorts B1 and B4 participants at least 2 prior regimens, in the locally advanced or metastatic setting\n  * There is no restriction on number of prior therapies\n* Cohort B5: Participants have not received prior systemic therapy for locally advanced or metastatic UC\n* FGFR inhibitor specific requirements:\n\n  * Cohort A1\u002FA2\u002FB3: Prior FGFR inhibitor treatment is permitted but not required\n  * Cohort B1\u002FB4: Participants must have been previously treated with erdafitinib\n  * Cohort B2, B5, and C1: Participants must be FGFR inhibitor naïve\n\nExclusion Criteria:\n\n* Participants with primary central nervous system (CNS) malignancy\n* Untreated or uncontrolled CNS metastases\n* Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible\n* Any serious unresolved toxicities from prior therapy\n* Significant cardiovascular disease\n* Prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF)\n* Active uncontrolled systemic infection or other clinically significant medical conditions\n* Participants who are pregnant, lactating, or plan to breastfeed during the study or within 6 months of the last dose of study treatment. Participants who have stopped breastfeeding may be enrolled",{"count":174,"type":21},535,[153],"The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435 by itself or when it is combined with other standard medicines that treat cancer. LOXO-435 may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Participation could last up to 30 months (2.5 years) and possibly longer if the disease does not get worse.",[28,29,178],"Ureteral Neoplasms",[156,180,181,182,183,184],"Bladder Urothelial Carcinoma","Urinary Bladder Cancer","Urinary Tract Cancer","Renal Pelvis Cancer","Ureter Cancer","2026-06-17",{"date":157,"type":38},{"date":188,"type":38},"2023-01-12",{"date":190,"type":21},"2027-06",{"name":44,"class":45},82,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":209,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100589912","phase-3-perioperative-durvalumab-with-neoadjuvant-ddmvac-or-gemcitabinecisplatin-in-patients-with-muscle-invasive-bladder-cancer-niagara-2-100589912","NCT06960577","Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine\u002FCisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)","A Phase IIIb, Open-label, Single-arm, Global Study of Perioperative Durvalumab With Neoadjuvant ddMVAC or Gem\u002FCis in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)","Inclusion Criteria:\n\n* Participants with clinical tumour stage T2-T4aN0\u002F1M0 or T1N1M0 with transitional or mixed transitional cell histology\n* Patients must be planning to undergo radical cystectomy\n* Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of muscle-invasive bladder cancer\n* ECOG performance status of 0 or 1\n* Minimum life expectancy of 12 weeks at first dose of study medication\n\nExclusion criteria:\n\n* Evidence of lymph node (N2-N3) or metastatic (M1) disease\n* Inoperable tumour(s) with fixation to the pelvic wall on clinical examination\n* Prior exposure to immune-mediated therapy including, but not limited to, other anti CTLA-4, anti-PD 1, anti-PD L1 and anti-PD-L2 antibodies, excluding Bacillus Calmette-Guérin\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab\n* Any concomitant medication known to be contraindicated to the chemotherapy (ddMVAC or gem\u002Fcis).\n* Uncontrolled intercurrent illness.",{"count":201,"type":21},150,[24],"The Phase IIIb NIAGARA-2 study aims to expand on the data from the Phase III NIAGARA study by investigating perioperative durvalumab in combination with investigator-selected cisplatin-based neoadjuvant chemotherapy (either ddMVAC or gemcitabine\u002Fcisplatin) in a clinical practice setting.",[28,205,206,207,208,72,75],"Immune Checkpoint Inhibitors","Methotrexate","Vinblastine","Doxorubicin",[210,156,211,212,213,214,75,72],"Muscle-invasive Bladder Cancer","Immunotherapy","Durvalumab","Perioperative Durvalumab","ddMVAC","2026-06-10",{"date":217,"type":38},"2026-06-11",{"date":219,"type":38},"2025-05-15",{"date":221,"type":21},"2028-10-31",{"name":223,"class":45},"AstraZeneca",59,{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":235,"briefSummary":237,"conditions":238,"keywords":239,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":252},"100548449","fapi-and-fdg-petmri-in-diagnosis-and-therapy-prediction-of-bladder-cancer-100548449","NCT06421142","FAPI and FDG PET\u002FMRI in Diagnosis and Therapy Prediction of Bladder Cancer","Application Research of FAPI Positron Emission Tomography(PET)\u002FMRI, 18F-Fluorodeoxyglucose (FDG) PET\u002FMRI, and MRI in the Diagnosis of Muscular Invasive Bladder Cancer and Evaluation of Neoadjuvant Therapy Efficacy","Inclusion Criteria:\n\n* Inclusion criteria for MIBC diagnostic studies\n\n  1. Patients with suspected muscle-invasive bladder cancer;\n  2. Completion of FAPI PET\u002FMRI, FDG PET\u002FMRI and MRI;\n  3. Complete clinical laboratory and pathological data.\n* Inclusion criteria for MIBC neoadjuvant therapy efficacy evaluation study\n\n  1. Patients diagnosed with muscle invasive bladder cancer;\n  2. Completion of FAPI PET\u002FMRI, FDG PET\u002FMRI, and MRI before neoadjuvant therapy;\n  3. Complete clinical laboratory and pathological data.\n\nExclusion Criteria:\n\n* Exclusion criteria for MIBC diagnostic study\n\n  1. Combined with other malignant tumors;\n  2. Not receiving surgical treatment;\n  3. Receiving neoadjuvant therapy before surgery;\n  4. Previous allergy to contrast components or similar components;\n  5. Serious organ function abnormalities, such as heart, lung, liver, kidney function serious abnormalities;\n  6. Incomplete clinicopathological data\n* Exclusion criteria of MIBC neoadjuvant therapy efficacy evaluation study\n\n  1. Combination of other malignant tumors;\n  2. FAPI PET\u002FMRI, FDG PET\u002FMRI and MRI were not completed after neoadjuvant therapy;\n  3. Prior hypersensitivity to contrast components or similar components;\n  4. Serious organ function abnormalities, such as serious abnormalities of heart, lung, liver and kidney function;\n  5. Incomplete clinicopathological data.","80 Years",{"count":234,"type":21},80,[236],"NA","The aim of this trial is to investigate the value of FAPI PET\u002FMRI, FDG PET\u002FMRI and MRI in diagnosing MIBC and predicting the efficacy of neoadjuvant therapy for MIBC patients, so as to guide the clinic to adjust the treatment plan in time and benefit MIBC patients.",[28],[240,241],"Neoadjuvant Chemotherapy","Neoplasm Staging","2026-05-28",{"date":244,"type":38},"2026-06-01",{"date":246,"type":38},"2024-08-02",{"date":248,"type":21},"2029-06-01",{"name":250,"class":251},"First Affiliated Hospital of Fujian Medical University","OTHER",1,{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":266,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":4},"100638046","phase-2-hope-07-mibc-disitamab-vedotin-plus-immunotherapy-vs-chemoimmunotherapy-in-resectable-her2-expressing-mibc-100638046","NCT07608224","HOPE-07-MIBC: Disitamab Vedotin Plus Immunotherapy vs Chemoimmunotherapy in Resectable HER2-Expressing MIBC","A Prospective, Randomized Controlled Study of Perioperative Disitamab Vedotin Plus Immunotherapy Versus Chemotherapy Plus Immunotherapy in Patients With Resectable HER2-Expressing Muscle-Invasive Bladder Cancer (HOPE-07-MIBC Study)","HOPE-07-MIBC","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent and comply with study requirements and scheduled assessments.\n2. Male or female patients aged ≥18 years at the time of signing informed consent.\n3. Histologically or radiologically confirmed muscle-invasive bladder cancer (MIBC) staged as cT2-T4aN0\u002F1M0 according to AJCC 8th edition, with residual disease after transurethral resection of bladder tumor (TURBT) as assessed by the investigator. All patients must have histological evidence of muscularis propria invasion. For mixed histology tumors, urothelial carcinoma must be the predominant component (≥50%).\n4. HER2 expression ≥1+ confirmed by immunohistochemistry (IHC) testing of pretreatment tumor tissue in a local laboratory.\n5. Deemed suitable for radical cystectomy as assessed by the investigator.\n6. No prior systemic chemotherapy or immunotherapy for muscle-invasive bladder cancer.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n8. Adequate organ function as defined by the following laboratory criteria obtained within 14 days prior to enrollment (unless otherwise specified):\n\n   Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL Platelet count ≥100 × 10⁹\u002FL Hemoglobin ≥90 g\u002FL International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN) Total bilirubin ≤1.5 × ULN AST, ALT, and alkaline phosphatase ≤2.5 × ULN Creatinine clearance (CrCl) \\>40 mL\u002Fmin Left ventricular ejection fraction (LVEF) ≥50% For borderline renal function: CrCl ≥40 to \\\u003C60 mL\u002Fmin (defined subgroup); adequate renal function: CrCl ≥60 mL\u002Fmin\n9. Women of childbearing potential must agree to use highly effective contraception during the study and for at least 180 days after the last dose of disitamab vedotin or toripalimab (whichever occurs later). A negative urine or serum pregnancy test is required within 7 days prior to enrollment.\n10. Non-sterilized male patients must agree to use highly effective contraception during the study and for at least 180 days after the last dose of disitamab vedotin or toripalimab (whichever occurs later).\n11. Life expectancy of more than 12 months.\n12. Willing and able to comply with study procedures and follow-up visits.\n\nExclusion Criteria:\n\n1. Prior treatment with therapies targeting PD-1, PD-L1, PD-L2, CTLA-4, HER2, or any other immune checkpoint or T-cell co-stimulatory pathways.\n2. Receipt of any systemic anticancer therapy or systemic immunomodulatory agents (e.g., interferon, interleukin-2, tumor necrosis factor) within 28 days prior to enrollment.\n3. Prior radiotherapy for bladder cancer.\n4. Prior systemic antitumor therapy for bladder cancer (e.g., chemotherapy), except for intravesical chemotherapy or immunotherapy completed at least 2 weeks prior to initiation of study treatment.\n5. Major surgery or significant traumatic injury within 28 days prior to enrollment. Placement of vascular access devices and transurethral resection of bladder tumor (TURBT) are not considered major surgery.\n6. Severe infections requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to enrollment (hepatitis B virus infection is addressed in exclusion criterion 12).\n7. Receipt of live vaccines within 28 days prior to enrollment (inactivated influenza vaccines are allowed; intranasal vaccines are considered live vaccines and are not allowed).\n8. Use of traditional Chinese medicine or proprietary Chinese medicine with anti-cancer intent within 14 days prior to enrollment.\n9. Active autoimmune disease requiring systemic treatment that may interfere with study therapy as judged by the investigator.\n10. Requirement for long-term systemic corticosteroids or other immunosuppressive therapy that may interfere with study treatment.\n11. Any uncontrolled comorbid conditions that may affect study participation, including but not limited to significant electrolyte abnormalities, hypoalbuminemia, interstitial lung disease, non-infectious pneumonitis, uncontrolled tuberculosis, neurological disorders, psychiatric disorders, or uncontrolled systemic diseases. This includes uncontrolled cardiovascular disease such as active cardiac disease within 6 months prior to enrollment, including severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, or clinically significant arrhythmias requiring treatment.\n12. Chronic hepatitis B infection with HBV DNA ≥500 IU\u002FmL (2500 copies\u002FmL) without adequate antiviral therapy. Patients with inactive HBsAg carrier status or well-controlled HBV infection (HBV DNA \\\u003C500 IU\u002FmL under antiviral therapy) may be eligible. HBV DNA testing is required only in HBsAg-positive patients.\n13. Active hepatitis C infection. Patients who are HCV antibody negative, or HCV antibody positive with negative HCV RNA, are eligible. HCV RNA testing is required for HCV antibody-positive patients.\n14. History of immunodeficiency, including HIV infection, other acquired or congenital immunodeficiency disorders, or prior allogeneic stem cell transplantation or solid organ transplantation.\n15. Known hypersensitivity to any study drug, its excipients, or other monoclonal antibodies.\n16. Pregnant or breastfeeding women.\n17. Concurrent participation in another interventional clinical trial.\n18. Presence of another active malignancy, except for adequately treated non-melanoma skin cancer or other malignancies considered cured.\n19. Any condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study",{"count":262,"type":21},240,[102,24],"This is a multicenter, randomized controlled clinical trial (HOPE-07) designed to evaluate the efficacy and safety of perioperative treatment with disitamab vedotin (RC48) combined with toripalimab compared with toripalimab combined with chemotherapy in patients with resectable HER2-expressing (HER2 1+, 2+, or 3+) muscle-invasive bladder cancer (MIBC, cT2-4aN0\u002F1M0).A total of 240 patients will be enrolled and randomized in a 1:1 ratio to receive either RC48 plus toripalimab or chemotherapy plus toripalimab, with 120 patients in each arm.\n\nThe primary objective is to compare 2-year event-free survival (2-year EFS) between the two treatment groups.\n\nSecondary endpoints include pathological complete response (pCR), event-free survival (EFS), disease-free survival (DFS), 1-year event-free survival (1-year EFS), metastasis-free survival (MFS), overall survival (OS), R0 resection rate, and safety outcomes including adverse events (AEs), serious adverse events (SAEs), vital signs, physical examination, ECOG performance status, laboratory tests, and electrocardiography, assessed according to CTCAE v5.0.\n\nExploratory objectives include assessment of quality of life using EQ-5D-5L and EORTC QLQ-C30, evaluation of associations between biomarkers (HER2 expression, PD-L1 expression, circulating tumor DNA) and treatment efficacy, and multi-omics analyses using tumor tissue, ctDNA, and urinary tumor DNA to identify potential predictive biomarkers.",[28],"NOT_YET_RECRUITING","2026-05-24",{"date":269,"type":38},"2026-05-27",{"date":271,"type":21},"2026-06-20",{"date":273,"type":21},"2030-12-31",{"name":275,"class":251},"West China Hospital",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":22,"phases":285,"briefSummary":286,"conditions":287,"keywords":299,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":323},"100392410","phase-1-a-study-of-sigvotatug-vedotin-in-advanced-solid-tumors-100392410","NCT04389632","A Study of Sigvotatug Vedotin in Advanced Solid Tumors","A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors","Inclusion Criteria:\n\n* Disease indication\n\n  * Participants must have histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the tumor types listed below (dependent on study part).\n\n    * Non-small cell lung cancer (NSCLC)\n    * Head and neck squamous cell cancer (HNSCC)\n    * Advanced HER2-negative breast cancer\n    * Esophageal squamous cell carcinoma (ESCC)\n    * Esophageal\u002FGastro-esophageal junction adenocarcinoma (EAC\u002FGEJ)\n    * Cutaneous squamous cell cancer (cSCC)\n    * Exocrine pancreatic adenocarcinoma\n    * Bladder cancer\n    * Cervical cancer\n    * Gastric cancer\n    * High grade serous ovarian cancer (HGSOC)\n  * Part A only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies and should have no appropriate standard-of-care therapeutic options.\n  * Part B only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies. Participants must have received platinum-based therapy and a PD-1\u002FPD-(L)1 inhibitor, if applicable and available.\n  * Part C only: For pembrolizumab combination cohorts, participants must be eligible for pembrolizumab per local standard of care. For pembrolizumab with cisplatin or carboplatin, participants must be eligible for both pembrolizumab and the platinum agent per local standard of care. Participants must be treatment naïve for locally advanced or metastatic systemic therapy (prior definitively intended or \\[neo\\]adjuvant therapy is allowed).\n  * Part D only: Participants must be treatment naïve for locally advanced or metastatic systemic therapy.\n* Participants enrolled in the following study parts should have a tumor site accessible for biopsy and agree to biopsy as follows:\n\n  * Disease-specific expansion cohorts (Part B and Part D): A baseline fresh tumor biopsy is required. An archival biopsy collected within 90 days prior to first dose of study drug may be used.\n  * Biology expansion cohort: pretreatment biopsy and on-treatment (Cycle 1) biopsy\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Measurable disease per the RECIST v1.1 at baseline\n\nExclusion Criteria\n\n* History of another malignancy within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.\n* Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:\n\n  * are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,\n  * have no new or enlarging brain metastases, and\n  * are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug.\n  * In Part D, participants with untreated, asymptomatic CNS metastases smaller than 1 cm may be enrolled without definitive treatment as long as they have no neurological symptoms, no or minimal surrounding edema, and no requirements for corticosteroids.\n* Carcinomatous meningitis\n* Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6\n* Pre-existing neuropathy Grade 1 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) for Parts C and D cohorts with cisplatin or carboplatin; Grade 2 or greater per the NCI CTCAE v5.0 for all other cohorts\n* Any uncontrolled Grade 3 or higher (per NCI CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of sigvotatug vedotin.\n\n  * Routine antimicrobial prophylaxis is permitted\n* Grade ≥3 pulmonary disease unrelated to underlying malignancy. This includes clinically severe pulmonary function compromise resulting from clinically significant pulmonary illnesses\n* Part C and D: Prior therapy with a PD-1 inhibitor, anti-PD-(L)1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a Grade 3 or higher immune-mediated adverse event (IMAE).\n* History of noninfectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening\n* Known diffusing capacity of the lung for carbon monoxide (DLCO; adjusted for hemoglobin) \\\u003C50% predicted\n* Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.",{"count":284,"type":21},1006,[153],"This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors.\n\nThe study will have four parts.\n\n* Part A of the study will find out how much sigvotatug vedotin should be given to participants.\n* Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors.\n* Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs.\n* Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors.\n* In Parts C and D, participants will receive sigvotatug vedotin with either:\n\n  * Pembrolizumab or,\n  * Pembrolizumab and carboplatin, or\n  * Pembrolizumab and cisplatin.",[288,289,290,291,292,293,294,295,296,28,297,298],"Carcinoma, Non-Small Cell Lung","Squamous Cell Carcinoma of Head and Neck","HER2 Negative Breast Neoplasms","Esophageal Squamous Cell Carcinoma","Esophageal Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Ovarian Neoplasms","Cutaneous Squamous Cell Cancer","Exocrine Pancreatic Adenocarcinoma","Uterine Cervical Neoplasms","Stomach Neoplasms",[300,301,302,303,304,305,306,307,308,309,310,311,156,312,313,314],"NSCLC","HNSCC","cSCC","ESCC","EAC","GEJ","HGSOC","Advanced HER2-Negative Breast Cancer","High Grade Serous Ovarian Cancer","Non-Small Cell Lung Cancer","Head and Neck Squamous Cell Cancer","Esophageal Cancer","Cervical Cancer","Gastric Cancer","Seattle Genetics","2026-05-08",{"date":86,"type":38},{"date":318,"type":38},"2020-06-08",{"date":320,"type":21},"2029-03-22",{"name":322,"class":45},"Seagen, a wholly owned subsidiary of Pfizer",159,{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":22,"phases":334,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":346},"100584708","phase-2-comparing-3-vs-6-cycles-of-platinum-based-chemotherapy-prior-to-maintenance-avelumab-in-advanced-urothelial-cancer-100584708","NCT06892860","Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer","A Randomised Phase II Study Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer","DISCUS","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent.\n2. Ability to comply with the protocol, including but not limited to, the repeated completion of the EORTC QLQ-C30 questionnaires.\n3. Age ≥ 18 years.\n4. Histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Patients with squamous or sarcomatoid differentiation or mixed cell types are eligible but a component of urothelial cancer is required.\n5. Measurable disease by RECIST v1.1.\n6. Eligible for gemcitabine\u002F cisplatin or gemcitabine\u002Fcarboplatin. The following criteria are established for the use of carboplatin (patients not fulfilling the following carboplatin criteria should be considered for gemcitabine\u002F cisplatin):\n\n   1. GFR \\\u003C60 mL\u002Fmin but ≥30 mL\u002Fmin (measured by the Cockcroft-Gault formula or by local accepted standards). Subjects with a GFR ≥50 mL\u002Fmin and no other cisplatin ineligibility criteria may be considered cisplatin-eligible based on the investigator's clinical judgement.\n   2. ECOG or WHO performance status of 2.\n   3. NCI CTCAE Grade ≥2 audiometric hearing loss.\n   4. NYHA Class III heart failure.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2.\n8. Adequate haematologic and organ function as defined below:\n9. Negative serum or urine pregnancy test within 2 weeks of Day 1 Cycle 1 for female patients of childbearing potential only.\n10. Agreement to use adequate contraceptive measures\n\nExclusion Criteria:\n\n* 1\\. Prior treatment with a PD-(L)-1 inhibitor for any advanced malignancy. Treatment with PD-(L)-1 inhibitors in the neoadjuvant or adjuvant setting for UC are permitted.\n\n  2\\. Prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions: a platinum containing regimen (cisplatin or carboplatin) in the neoadjuvant or adjuvant setting if more than 6 months since last cycle have occurred. Patients who received adjuvant or neoadjuvant immune therapy for muscle invasive or non-muscle invasive disease are eligible.\n\n  3\\. Pregnant and lactating female patients. 4. Known history of active CNS metastases. Patients with treated CNS metastases are permitted on the study if all of the following are true: 5. Prior allogeneic stem cell or solid organ transplantation. 6. Administration of a live, attenuated vaccine within 4 weeks prior to enrolment or anticipation that such a live, attenuated vaccine will be required during the study.\n\n  7\\. Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin \\[IL\\]-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrolment (see section 11.26).\n\n  8\\. Concurrent treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to enrolment.\n\n  9\\. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome).\n\n  10\\. Malignancies other than urothelial carcinoma within 3 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer (Gleason score ≤ 3 + 4 and PSA \\\u003C 10 ng\u002FmL undergoing active surveillance and treatment naive). .\n\n  11\\. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction or cerebral vascular accident\u002Fstroke within 6 months prior to enrolment, unstable arrhythmias, or unstable angina.\n\n  12\\. Radiotherapy within 2 weeks prior to C1D1. Patients must have recovered adequately from toxicities resulting from the intervention prior to starting study treatment.\n\n  13\\. Major surgery (defined as requiring general anaesthesia and \\>24-hour inpatient hospitalization) within 4 weeks prior to randomisation. Patients must have recovered adequately from complications from the intervention prior to starting study treatment.\n\n  14\\. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan (History of radiation pneumonitis in the radiation field (fibrosis) is permitted).\n\n  15\\. Active hepatitis infection (defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen \\[anti-HBc\\] antibody test) are eligible.\n\n  16\\. Positive HIV test. 17. Active tuberculosis. 18. Active autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.\n\n  19\\. History of autoimmune-related hypothyroidism, unless on a stable dose of thyroid replacement hormone.\n\n  20\\. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies.\n\n  21\\. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of avelumab.\n\n  22\\. Active infection requiring systemic therapy. 23. Persisting toxicity related to prior therapy (NCI CTCAE Grade \\> 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.\n\n  24\\. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results 25. Participants with previous or known history of allergic reaction to cisplatin, gemcitabine, carboplatin or other platinum containing compounds, or any component of the chemotherapy formulations.\n\n  26\\. Patients with bleeding tumours 27. Any other contraindication for gemcitabine\u002F cisplatin or gemcitabine\u002Fcarboplatin treatment as per SmPC.",{"count":333,"type":21},320,[102],"This is an adaptive, open-label, randomised phase II trial that aims to evaluate the impact of 3 vs 6 cycles of first-line platinum-based chemotherapy followed by maintenance avelumab in the quality of life of patients with locally advanced or metastatic urothelial cancer. Initially, 224 eligible and evaluable patients (112 in each arm) will receive 3 cycles vs 6 cycles of 3-weekly gemcitabine plus cisplatin\u002Fcarboplatin, followed by 2-weekly maintenance avelumab until disease progression or intolerable toxicities. Avelumab treatment will be given up to a maximum of 2 years from the end of chemotherapy.",[28],"2026-05-05",{"date":339,"type":38},"2026-05-06",{"date":341,"type":38},"2021-12-16",{"date":343,"type":21},"2027-12-22",{"name":345,"class":251},"Queen Mary University of London",3,{"id":348,"slug":349,"hasResults":11,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":22,"phases":357,"briefSummary":358,"conditions":359,"keywords":363,"overallStatus":266,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":252},"100610763","hyperthermic-intravesical-chemotherapy-hivec-in-bcg-non-responsive-high-grade-nmibc-patients-100610763","NCT07231809","Hyperthermic Intravesical Chemotherapy (HIVEC) in BCG-Non-Responsive High-Grade NMIBC Patients","Hyperthermic Intravesical Chemotherapy (HIVEC) In Patients With BCG-Non Responsive Or Intolerant High-Grade BCG-Infiltrating Non-Muscle-Infiltrating Bladder Cancer And Not Eligible For Radical Cystectomy: Phase II Study (SMG-Bladder 01).","HIVEC","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed high-grade non-muscle-invasive bladder cancer (NMIBC), including Ta, T1, and\u002For carcinoma in situ (CIS).\n* BCG-unresponsive or BCG-intolerant disease according to international definitions (persistent or recurrent high-grade NMIBC after adequate BCG therapy).\n* Patient is ineligible for, or refuses, radical cystectomy.\n* Candidate for hyperthermic intravesical chemotherapy (HIVEC) according to clinical judgment.\n* ECOG Performance Status 0-2.\n* Adequate organ function according to institutional standards.\n* Ability and willingness to comply with study procedures and follow-up schedule.\n* Written informed consent obtained.\n\nExclusion Criteria:\n\n* Muscle-invasive bladder cancer (≥ T2) or metastatic disease.\n* Active urinary tract infection at baseline.\n* Previous treatment with HIVEC or other intravesical hyperthermia systems.\n* Known hypersensitivity to Mitomycin C or contraindications to intravesical chemotherapy.\n* Active uncontrolled bleeding or gross hematuria preventing intravesical instillation.\n* Upper urinary tract urothelial carcinoma.\n* Pregnant or breastfeeding women.\n* Any medical or psychological condition that, in the investigator's judgment, could interfere with study participation or compromise patient safety.",{"count":356,"type":21},50,[236],"This is a Phase II, prospective, single-arm, open-label clinical study evaluating hyperthermic intravesical chemotherapy (HIVEC) with Mitomycin C in patients with high-grade, non-muscle-invasive bladder cancer (NMIBC) who are BCG-non-responsive or BCG-intolerant and are ineligible for, or refuse, radical cystectomy. Mitomycin C is an approved medicinal product used within routine clinical practice and administered with a CE-marked recirculation device (BRS Combat system) that maintains the solution at approximately 43°C for 60 minutes. The treatment schedule consists of 6 weekly induction instillations followed by 9 monthly maintenance instillations.\n\nThe co-primary objectives are to describe the safety and toxicity profile of HIVEC, including treatment discontinuations due to procedure-related toxicity, and to estimate the 12-month recurrence-free survival (12moRFS). Secondary objectives include characterizing patterns of non-muscle-invasive and muscle-invasive recurrences, bladder cancer-specific survival, overall survival, and quality of life. Approximately 50 patients will be enrolled in this single-center pilot study to generate exploratory safety and efficacy data in this high-risk population and to support the design of future randomized trials",[360,156,361,28,362],"Non Muscle Invasive Bladder Cancer","Carcinoma in Situ of Bladder","Carcinoma, Transitional Cell, Bladder",[353,364,365,366,367,368],"Hyperthermic Intravesical Chemotherapy","Mitomycin C","BRS Combat System","Bladder Tumor Recurrence","High-Grade Bladder Cancer","2026-05-04",{"date":339,"type":38},{"date":372,"type":21},"2026-10-15",{"date":374,"type":21},"2028-05-31",{"name":376,"class":45},"AC.TA. S.r.l.",{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":384,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":392,"overallStatus":266,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":404},"100635674","an-international-multicenter-clinical-study-on-application-of-uromed-ai-doctor-based-on-large-language-models-100635674","NCT07555756","An International Multicenter Clinical Study on Application of UroMed AI Doctor Based on Large Language Models","AN INTERNATIONAL MULTICENTER CLINICAL STUDY ON APPLICATION OF UROMED AI DOCTOR BASED ON LARGE LANGUAGE MODELS","Inclusion Criteria:\n\n* Diagnosed with kidney stones, benign prostatic hyperplasia, or bladder cancer in line with the Chinese Guidelines for the Diagnosis and Treatment of Urological and Andrological Diseases (2022 Edition) and requiring hospitalization for surgery.\n\nAged 18 to 60 years with good communication skills. Voluntarily agrees to participate in the clinical study and has signed the informed consent form.\n\nExclusion Criteria:\n\n* Suffers from psychiatric disorders. Refuses to participate in medical activities involving the use of artificial intelligence systems.\n\nUnable to engage in effective communication with the research team. Has multiple underlying diseases with unstable clinical conditions.","60 Years",{"count":386,"type":21},1080,[236],"This study evaluates our team's urology-specific AI (UroMed AI Doctor) for its safety, professionalism, knowledge and Q\\&A ability, and tests its effectiveness against traditional manual urology care, to confirm if it can be a safe auxiliary tool and improve patients' preoperative experience.\n\nBefore the study, we will test the AI with urology questions, compare it to international AI models (DeepSeek, ChatGPT, Google Gemini), and have two senior chief physicians evaluate it.\n\nIn the clinical trial, patients at The First Affiliated Hospital of Guangxi Medical University will be randomly split into two groups: AI-assisted care or traditional care by a specialist.\n\nTwo senior specialists will evaluate both groups blindly; each group will get preoperative education (AI or physician), with anxiety and satisfaction surveyed.\n\nSubsequently, a multi-center validation will be conducted with 11 domestic and international hospitals.",[390,391,28],"Kidney Calculi","Prostatic Hyperplasia",[393,394],"UroMed AI Doctor","Urology","2026-04-21",{"date":397,"type":38},"2026-04-29",{"date":399,"type":21},"2026-05-01",{"date":401,"type":21},"2029-07-31",{"name":403,"class":251},"First Affiliated Hospital of Guangxi Medical University",5,{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":414,"phases":4,"briefSummary":415,"conditions":416,"keywords":420,"overallStatus":266,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":435,"locationsCount":4},"100633335","immune-stromal-landscape-in-muscle-invasive-bladder-cancer-100633335","NCT07525349","Immune-Stromal Landscape in Muscle-Invasive Bladder Cancer","The Immune-Stromal Landscape of Muscle-Invasive Urothelial Bladder Carcinoma: A Morphological Histopathological Study","Inclusion Criteria:\n\n* Patients who underwent radical cystectomy for muscle invasive urothelial carcinoma.\n* Treated at the South Egypt Cancer Institute (SECI) between 2018 and 2024.\n\nExclusion Criteria:\n\n* Cases with non-urothelial histological subtypes (e.g., pure squamous cell carcinoma).\n* Patients who received neoadjuvant chemotherapy or radiotherapy.\n* Cases with missing or inaccessible clinical follow-up data.\n* History of prior or concurrent malignancy.",{"count":413,"type":21},100,"OBSERVATIONAL","Bladder cancer is a significant global health issue. When the cancer spreads into the muscle layer of the bladder (muscle-invasive bladder cancer), a common treatment is the surgical removal of the bladder (radical cystectomy). However, even after surgery, it can be difficult for doctors to accurately predict how an individual patient's disease will progress using standard staging methods.\n\nThis retrospective observational study aims to find better ways to predict patient outcomes by examining the tumor microenvironment, which is the environment immediately surrounding the cancer cells. Specifically, researchers are looking at the relationship between the tumor cells, the surrounding supportive tissue (the stroma), and the patient's natural immune cells.\n\nThe study will review existing medical records and archived tumor tissue samples from at least 100 patients who underwent radical cystectomy at the South Egypt Cancer Institute between 2018 and 2024. Under a microscope, researchers will assess three main features:\n\n* Tumor-Stroma Ratio (TSR): The amount of tumor tissue compared to the surrounding supportive tissue.\n* Tumor-Infiltrating Lymphocytes (TILs): The number of immune cells that have moved into the tumor to try and fight it.\n* Tertiary Lymphoid Structures (TLS): Organized clusters of immune cells that form near the tumor.\n\nBy analyzing these features, the researchers hope to determine if specific patterns of immune and supportive cells are linked to better or worse survival rates, such as Overall Survival and Disease-Free Survival. Understanding this immune-stromal landscape could lead to more personalized risk assessments and better treatment plans for future bladder cancer patients.",[417,418,156,419,28],"Muscle-Invasive Bladder Carcinoma","Urothelial Carcinoma (UC)","Muscle-Invasive Urothelial Bladder Carcinoma",[421,79,422,423,424,425,426,427,428],"Muscle-Invasive Bladder Cancer (MIBC)","Radical Cystectomy","Tumor Microenvironment","Tumor-Stroma Ratio (TSR)","Tumor-Infiltrating Lymphocytes (TILs)","Tertiary Lymphoid Structures (TLS)","Glasgow Microenvironment Score (GMS)","Klintrup-Mäkinen (KM) Score","2026-04-07",{"date":431,"type":38},"2026-04-13",{"date":433,"type":21},"2026-05",{"date":190,"type":21},{"name":436,"class":251},"Assiut University",{"id":438,"slug":439,"hasResults":11,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":17,"minAge":445,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":22,"phases":448,"briefSummary":449,"conditions":450,"keywords":452,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":464,"locationsCount":252},"100631007","early-vs-delayed-intravesical-blad-care-during-bcg-therapy-100631007","NCT07495072","Early vs Delayed Intravesical Blad-Care During BCG Therapy","Optimal Timing of Intravesical GAG Restoration Therapy for BCG-Induced Bladder Toxicity in Patients With Non-Muscle-Invasive Bladder Cancer: A Prospective Randomized Study","PRO-GAG","Inclusion Criteria:\n\n* Adults aged ≥19 years\n* Histologically confirmed non-muscle-invasive bladder cancer\n* Candidates for intravesical BCG therapy\n* Negative urine culture prior to BCG therapy\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Hypersensitivity to components of Blad-Care\n* Contraindication to BCG therapy\n* Neurogenic bladder or significant urinary tract abnormalities\n* Severe renal dysfunction\n* Any condition considered unsuitable for study participation by the investigator","19 Years",{"count":447,"type":21},56,[236],"Intravesical Bacillus Calmette-Guérin (BCG) therapy is the standard adjuvant treatment for patients with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC). However, BCG therapy frequently induces local bladder irritation symptoms including urinary frequency, urgency, dysuria, hematuria, and suprapubic pain, which may reduce quality of life and lead to treatment interruption.\n\nBlad-Care™ is an intravesical therapy containing hyaluronic acid and chondroitin sulfate, key components of the urothelial glycosaminoglycan (GAG) layer. Restoration of the GAG layer may protect the bladder mucosa and reduce inflammation-induced bladder irritation symptoms.\n\nThis prospective randomized study aims to determine whether early administration of intravesical Blad-Care during BCG induction improves BCG-induced bladder toxicity compared with delayed administration after completion of BCG induction therapy.",[28,451],"BCG-Induced Cystitis",[453,454,455,456,457],"Hyaluronic Acid","BCG-induced Cystitis","BCG-related Bladder Pain","Non-Muscle Invasive Bladder Cancer (NMIBC)","Interstitial Cystitis","2026-03-21",{"date":460,"type":38},"2026-03-27",{"date":462,"type":38},"2025-11-03",{"date":190,"type":21},{"name":465,"class":251},"BLAD-HYA Group",{"id":467,"slug":468,"hasResults":11,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":414,"phases":4,"briefSummary":475,"conditions":476,"keywords":480,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":493},"100459570","lymphedema-after-urologic-surgery-100459570","NCT05264337","Lymphedema After Urologic Surgery","Lymphedema in the Lower Extremities After Urologic Surgery With Lymph Node Dissection","Inclusion Criteria:\n\n* Patients undergoing urologic surgery with lymph node dissection\n\nExclusion Criteria:\n\n* None",{"count":474,"type":21},400,"Lymphedema of the extremities is common after lymph node surgery in treating several forms of cancer, e.g., breast cancer. However, very little is known of the occurrence of lymphedema of the lower extremities after urologic surgery with lymph node dissection. This project aims to describe the frequency and grade of lymphedema arising after urologic surgery, using the Lymphedema Quality of Life Questionnaire (LymQOL), Delfin MoistureMeter D, and lower limb volume measurements.",[28,477,478,479],"Prostatic Neoplasms","Testicular Neoplasms","Penile Cancer",[481,482],"Lymphedema","Lymph Node Excision","2026-01-15",{"date":485,"type":38},"2026-01-16",{"date":487,"type":38},"2022-03-14",{"date":489,"type":21},"2030-01",{"name":491,"class":492},"Vastra Gotaland Region","OTHER_GOV",2,{"id":495,"slug":496,"hasResults":11,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":501,"enrollmentInfo":502,"targetDuration":4,"studyType":22,"phases":504,"briefSummary":506,"conditions":507,"keywords":508,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":252},"100390869","early-phase-1-virtual-histology-of-the-bladder-wall-for-bladder-cancer-staging-100390869","NCT04369560","Virtual Histology of the Bladder Wall for Bladder Cancer Staging","Virtual Histology of the Bladder Wall for Bladder Cancer Staging; A Novel Intravesical Contrast-Enhanced MRI for Bladder Cancer Staging","Inclusion Criteria:\n\n1. 18 to 90 years of age\n2. Able to understand and willing to sign a written informed consent document\n3. A papillary tumor identified by cystoscopy that has been scheduled for TURBT OR histologically proven MIBC that is clinically localized and amenable to surgical resection with curative intent.\n4. Performance status of ECOG 0 or 1\n5. Normal renal function as defined as creatinine less than 1.5 x institutional upper limit of normal (ULN) OR creatinine clearance greater than or equal to 50 mL\u002Fmin\u002F1.73 m2 by Cockcroft-Gault formula for subjects with creatinine levels greater than or equal to 1.5 x ULN.\n\nExclusion Criteria:\n\n1. Severe hypersensitivity reaction to gadobutrol or ferumoxytol.\n2. Severe claustrophobia that will prevent completion of the MRI study.\n3. Any MRI-non-compatible implanted device, prosthetic or pacemaker.\n4. Known or suspected metastatic disease.\n5. Women with active pregnancy, lactation or plans to conceive\n6. Untreated urinary tract infection\n7. Known urethral stricture disease that would prohibit placement of foley catheter.\n8. Any other conditions considered as unacceptable risk by the treating physician","90 Years",{"count":503,"type":21},42,[505],"EARLY_PHASE1","This is a phase Ib study of the safety and performance of a novel intravesical contrast-enhanced Magnetic Resonance Imaging protocol for determination of bladder cancer stage prior to transurethral resection of bladder tumor (21 subjects) or prior to radical cystectomy for muscle invasive disease (21 subjects). Subjects will undergo a single MRI study: a pre-contrast, single breath hold image followed by sterile placement of a temporary urethral catheter for instillation of a 50mL solution containing Gadobutrol (4 mM) plus ferumoxytol (5 mM) and then a second, post-contrast image. Images will be reviewed by two dedicated abdominal radiologists, who are blinded to the pathologic staging, for determination of tumor presence and depth of bladder wall penetration.",[28],[509,510],"TURBT","Complete Cystectomy","2025-12-11",{"date":513,"type":38},"2025-12-17",{"date":515,"type":38},"2025-05-23",{"date":517,"type":21},"2028-12-30",{"name":519,"class":251},"Jodi Maranchie",{"id":521,"slug":522,"hasResults":11,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":526,"eligibilityCriteria":527,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":22,"phases":530,"briefSummary":531,"conditions":532,"keywords":534,"overallStatus":266,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":252},"100607533","phase-2-toripalimab--sequential-intravesical-gemcitabine-mitomycin-c-for-bcg-unresponsive-intolerant-high-risk-nmibc-open-label-randomized-phase-2-study-100607533","NCT07189793","Toripalimab ± Sequential Intravesical Gemcitabine-Mitomycin C for BCG-Unresponsive\u002F-Intolerant High-Risk NMIBC: Open-Label Randomized Phase 2 Study","Toripalimab With Sequential Intravesical Gemcitabine-Mitomycin C Versus Toripalimab Alone for the Treatment of BCG-Unresponsive\u002F-Intolerant High-Risk Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized, Multicenter, Phase 2 Study","OHAI-NMIBC-01","Inclusion Criteria:\n\n1. Age ≥18 years; sex: all; signed written informed consent by the participant or legally authorised representative.\n2. Histologically confirmed high-risk non-muscle-invasive bladder cancer (HR-NMIBC), defined as any T1, high-grade Ta, and\u002For carcinoma in situ (CIS).\n3. BCG-intolerant (unable to continue BCG because of severe adverse reactions) or meeting at least one definition of BCG treatment failure:\n\n   1. Persistent or recurrent CIS within 12 months after completion of adequate BCG (with or without concomitant NMIBC);\n   2. Recurrent high-grade Ta\u002FT1 within 6 months after completion of adequate BCG;\n   3. High-grade T1 at the first evaluation after BCG induction (\\~3 months);\n   4. Ta high-grade and\u002For CIS present or recurrent at \\~3 months after receiving ≥5 BCG instillations.\n\n   Adequate BCG, for the purposes of this protocol, is defined as receipt of at least 5 of 6 induction instillations (maintenance not required).\n4. ECOG performance status 0-2.\n5. Adequate organ function per protocol laboratory criteria.\n6. No intravesical chemotherapy or immunotherapy between the most recent cystoscopy\u002FTURBT and study start; a single immediate postoperative intravesical chemotherapy at the time of the most recent cystoscopy\u002FTURBT is allowed during screening per local practice.\n7. Willing and able to comply with study procedures.\n\nExclusion Criteria:\n\n1. Muscle-invasive bladder cancer (T2-T4).\n2. Low-grade (LG) recurrence during or after BCG therapy.\n3. Concomitant upper tract urothelial carcinoma, or lymph-node\u002Fdistant metastasis.\n4. Indwelling ureteral stent or known vesicoureteral reflux.\n5. Contraindications to intravesical instillation, including within 2 weeks after TURBT, bladder perforation, symptomatic urinary tract infection, or gross haematuria.\n6. Known hypersensitivity or contraindication to gemcitabine, mitomycin C, or toripalimab.\n7. Systemic chemotherapy, small-molecule targeted therapy, or radiotherapy within 2 weeks before first study treatment.\n8. Prior immune checkpoint inhibitor therapy.\n9. Pregnant, planning pregnancy, or breastfeeding women.\n10. Ongoing acute or chronic systemic infection, or history of active tuberculosis.\n11. Other malignancy requiring active treatment.\n12. Any condition that, in the investigator's judgment, makes participation not in the patient's best interest or could confound study results.\n\nStudy Population Adults with BCG-unresponsive or BCG-intolerant HR-NMIBC treated at participating centres in China.",{"count":529,"type":21},106,[102],"This open-label, randomised, multicentre, phase 2 study (OHAI-NMIBC-01) compares toripalimab plus sequential intravesical gemcitabine followed by mitomycin C (GEM→MMC) with toripalimab alone in adults with BCG-unresponsive or BCG-intolerant high-risk non-muscle-invasive bladder cancer (HR-NMIBC). Two prespecified cohorts are analysed: (1) CIS cohort (CIS with\u002Fwithout Ta\u002FT1) and (2) non-CIS cohort (high-risk Ta\u002FT1 without CIS). In the combination arm, intravesical GEM→MMC is given weekly for 6 weeks (induction) and, for patients without recurrence at the first tumour assessment (\\~month 3), monthly maintenance continues up to 24 months or until progression\u002Funacceptable toxicity; toripalimab IV every 3 weeks starts during the first intravesical cycle and continues up to 24 months or until progression\u002Funacceptable toxicity. The monotherapy arm receives toripalimab IV every 3 weeks up to 24 months or until progression\u002Funacceptable toxicity. Cystoscopy and urine cytology are performed every 3 months; imaging every 24 weeks. Primary endpoints are 3-month complete response (CR) rate in the CIS cohort and median recurrence-free survival (RFS) in the non-CIS cohort. Secondary endpoints include landmark CR, PFS and OS, RFS\u002FHG-RFS landmarks in the non-CIS cohort, and safety (CTCAE v5.0). Exploratory analyses will assess outcomes by protocol-defined PD-L1 status. Approximately 106 participants will be enrolled at multiple sites in China.",[28,27,361,533],"Non-Muscle-Invasive Bladder Cancer",[535,536,537,538,539,540,541,542,543,75,365,544,545,546,547],"NMIBC","High-Risk NMIBC","BCG-Unresponsive","BCG-Intolerant","BCG Failure","Carcinoma in Situ (CIS)","Intravesical Therapy","Ta","T1","GEM-MMC","Toripalimab","PD-1 Inhibitor","Bladder-Sparing","2025-09-17",{"date":550,"type":38},"2025-09-24",{"date":552,"type":21},"2025-10",{"date":554,"type":21},"2028-10",{"name":556,"class":251},"First Affiliated Hospital of Wenzhou Medical University",{"id":558,"slug":559,"hasResults":11,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":564,"enrollmentInfo":565,"targetDuration":4,"studyType":22,"phases":567,"briefSummary":568,"conditions":569,"keywords":570,"overallStatus":266,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":252},"100583792","antarctic-krill-oil-functional-food-mitigates-bladder-cancer-treatment-side-effects-100583792","NCT06880939","Antarctic Krill Oil Functional Food Mitigates Bladder Cancer Treatment Side Effects","Randomized, Double-Blind, Parallel-Controlled, Multicenter Clinical Study on the Efficacy of Antarctic Krill Oil Functional Food in Alleviating Side Effects of Intravesical Therapy for Bladder Cancer","Inclusion Criteria:\n\n* 1\\. Diagnosed bladder cancer: The patient needs to be diagnosed with bladder cancer through pathological examination and have undergone bladder cancer surgery.\n* 2\\. Planned to receive bladder infusion therapy: Patients need to plan to receive bladder infusion therapy after surgery and agree to participate in the study.\n* 3\\. Age range: 18 to 75 years old.\n* 4\\. Normal blood, liver and kidney function: Laboratory tests showed that the patient's blood routine, liver function and kidney function were within the normal range.\n* 5\\. Signed informed consent: The patient understands the content of the study and voluntarily signs the informed consent.\n\nExclusion Criteria:\n\n* 1\\. Serious comorbidities: including but not limited to heart disease, severe liver and kidney insufficiency, uncontrolled hypertension, diabetes, etc.\n* 2\\. History of allergies: Patients with a known history of allergy to krill oil or perfusion drug components.\n* 3\\. History of prior chemotherapy: Patients who have received perfusion therapy prior to this study.\n* 4\\. History of other malignant tumors: Patients with a history of other malignant tumors.\n* 5\\. Pregnancy or lactation: Female patients who are pregnant or lactating.\n* 6\\. Psychiatric illness: Patients with a history of severe psychiatric illness or currently receiving treatment for psychiatric illness.\n* 7\\. Poor study compliance: Patients who believe that they are unable to complete the entire trial process as required by the study.\n* 8\\. Other: Other conditions that the investigator considers unsuitable to participate in this study.","75 Years",{"count":566,"type":21},210,[236],"This randomized, double-blind, placebo-controlled, multicenter trial evaluates the efficacy and safety of Antarctic krill oil in reducing side effects of intravesical therapy for non-muscle-invasive bladder cancer (NMIBC). A total of 210 participants (18-75 years) will be randomized to receive either 2g\u002Fday of krill oil capsules (containing phospholipids, DHA, EPA, and astaxanthin) or placebo during intravesical treatment (epirubicin, pirarubicin, or BCG).\n\nPrimary outcomes include bladder irritation symptoms (IPSS score), systemic adverse events, hematuria, and urinary tract infections. Secondary outcomes assess quality of life (QoL). Safety will monitor adverse events per CTCAE v5.0.\n\nThe study follows GCP standards and includes rigorous data management and ethical oversight. Results may offer a dietary intervention to improve treatment tolerance and QoL for bladder cancer patients.",[28],[156,571,541,572,573],"Krill Oil","Adverse Effects","Randomized Controlled Trial","2025-07-20",{"date":576,"type":38},"2025-07-24",{"date":578,"type":21},"2025-07-15",{"date":580,"type":21},"2028-05-30",{"name":582,"class":251},"Qilu Hospital of Shandong University",{"id":584,"slug":585,"hasResults":11,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":22,"phases":591,"briefSummary":592,"conditions":593,"keywords":604,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":616,"locationsCount":404},"100511807","phase-1-htl0039732-in-participants-with-advanced-solid-tumours-100511807","NCT05944237","HTL0039732 in Participants With Advanced Solid Tumours","A Cancer Research UK Phase I\u002FIIa Trial of HTL0039732, Given Orally as Monotherapy and in Combination With Immunotherapy or Other Approved Therapies in Participants With Advanced Solid Tumours","Inclusion Criteria:\n\n1. Written (signed and dated) informed consent and capable of co-operating with investigational medicinal product administration and follow-up.\n2. Phase 1, dose escalation phase\n\n   Part A (HTL0039732 monotherapy):\n   * Histologically or cytologically proven advanced solid tumour, refractory to conventional treatment, or for which no further conventional therapy is considered appropriate by the Investigator or is declined by the potential participant.\n   * At least 1 measurable lesion according to RECIST v1.1, which (in the Investigator's opinion) has had objective radiological progression on or after the last therapy, or at least one assessable lesion e.g. pleural or peritoneal thickening that does not fulfil RECIST v1.1 criteria for measurable disease.\n\n     a. Consent for fresh tumour biopsy sample(s) at time of PD, if the participant has accessible disease and is eligible to receive atezolizumab. Optional at time of disease progression.\n   * Consent to access and analysis of any available archival tissue or a fresh tumour sample at baseline, if archival tissue is unavailable.\n   * Consent for fresh tumour biopsy sample(s) at time of PD, if the participant has accessible disease and is eligible to receive atezolizumab. Optional at time of disease progression.\n\n   Phase 1 Part B:\n\n   \\- Histologically proven advanced solid tumour where PGE2\u002FEP4 signalling is believed to be more prevalent or significant (such as microsatellite stable colorectal cancer (MSS CRC), gastro-esophageal cancer, head and neck squamous cell carcinoma (HNSCC), mCRPC, pancreatic cancer, lung cancer, bladder cancer, mesothelioma, cervical cancer, renal cancer, sarcoma, pheochromocytoma and cancers with PI3K\u002FAKT\u002FmTOR pathway activating mutations using a clinically-validated assay).\n\n   Phase 2a:\n\n   \\- Histologically proven advanced solid tumour, in line with indications listed below, refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the potential participant:\n   1. MSS CRC with PIK3CA or HER2 mutation, and\u002For other driver mutation as agreed with the Sponsor (genomic alteration to have been previously identified using a validated next-generation sequencing method performed on either tumour tissue or circulating tumour DNA \\[ctDNA\\]);\n   2. Gastric or gastroesophageal junction (GOJ) adenocarcinoma;\n   3. Clear cell renal cell carcinoma;\n   4. mCRPC\n\n   Phase 1 Part B and Phase 2a:\n   * Consent to access and analysis of any available archival tissue.\n   * Consent for fresh tumour biopsy samples at baseline and on treatment. However, the following exceptions will be permitted if archival tissue is available at the recruiting site:\n\n     1. Patients with mCRPC: biopsies are not required for those whose only safely accessible lesions are bone metastases that lack an accessible soft tissue component.\n     2. For the first 12 participants in each indication: the on-trial biopsy is optional; and the baseline biopsy is mandatory if there is a safely accessible lesion but may be omitted for patients who have no safely accessible lesion, to permit their inclusion in the study. This will continually be assessed through the study.\n   * Disease refractory to conventional treatment, or for which no further conventional therapy is considered appropriate by the Investigator or is declined by the participant.\n   * Except for mCRPC, at least 1 measurable lesion according to RECIST v1.1, which (in the Investigator's opinion) has had objective radiological progression on or after the last therapy. Potential participants with mCRPC may instead have had PD according to PCWG3 criteria.\n\n     1. Previously irradiated lesions cannot be counted as target lesions unless clearly progressed after the radiotherapy.\n     2. Lesions that are intended to be biopsied should not be counted as target lesions (those undergoing biopsy must have at least one target lesion that is not intended to be biopsied).\n   * For indications where anti-PD-1\u002FPD-L1 therapy is standard of care (such as clear cell renal cell carcinoma, or gastric or GOJ adenocarcinoma with elevated PD-L1 expression), patients must have received that therapy and must be considered to have had progressive disease by the Investigator either on, or within 6 months after, that treatment.\n3. Life expectancy of at least 12 weeks.\n4. Eastern Cooperative Oncology Group performance status of 0 or 1.\n5. Haematological and biochemical indices within the protocol specified ranges.\n6. Stable thyroid function tests. Stable doses of thyroxine replacement are permitted.\n7. Aged 18 years or over at the time consent is given.\n\nExclusion Criteria:\n\n1. Radiotherapy (except for palliative reasons), chemotherapy, non chemotherapy systemic anti-cancer therapy (apart from life-long hormone suppression such as luteinising hormone-releasing agents in participants with mCRPC) or investigational medicinal products during the 4 weeks prior to enrolment; or first dose of an immunotherapy during the previous 12 weeks before first dose of HTL0039732.\n2. Ongoing toxic manifestations of previous treatments that are Grade \\>1 per CTCAE v5.0.\n3. Any central nervous system metastases (unless potential participants have had local therapy and are asymptomatic, radiologically stable and have been off steroids for ≥4 weeks prior to enrolment).\n4. Women of child-bearing potential (or who are already pregnant or lactating). Exceptions apply.\n5. Men with partners of childbearing potential. Exceptions apply.\n6. Major thoracic or abdominal surgery from which the potential participant has not yet recovered.\n7. At high medical risk because of non-malignant systemic disease, including active uncontrolled infection.\n8. Known history of current or latent tuberculosis, HIV or Hepatitis B or C infection.\n9. Prior treatment with EP4 inhibitor.\n10. Treatment with selective cyclooxygenase-2 inhibitor in the 8 weeks prior to enrolment.\n11. Known hypersensitivity or intolerance to hydroxypropyl methylcellulose.\n12. Use of systemic immunosuppressive agent in the 2 weeks prior to enrolment. Exceptions apply.\n13. Significant cardiovascular disease.\n14. Known active peptic ulcer disease, or symptoms of gastritis, dyspepsia or gastro-esophageal reflux disease (one or more episodes per week).\n15. Current or planned participation in another interventional clinical trial, whilst taking part in this trial of HTL0039732.\n16. Limited ability to swallow or absorb oral medications.\n17. Any other condition that, in the Investigator's opinion, would mean that the trial is not in the best interests of the potential participant.\n\n    Phase 1 Part B and Phase 2a:\n18. Any live vaccines in the 4 weeks prior to enrolment.\n19. Diagnosis of immunodeficiency.\n20. Active autoimmune disease requiring systemic treatment in the 2 years prior to enrolment.\n21. History or clinical suspicion of interstitial lung disease, history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.\n22. Hypersensitivity to atezolizumab or any of its excipients.\n23. Prior adverse reaction to cancer immunotherapy that required steroid or other immunosuppressive treatment or led to discontinuation of that treatment.",{"count":201,"type":21},[153,102],"The purpose of this trial is to evaluate a new drug, HTL0039732, that will be administered on its own (as a monotherapy) and in combination with atezolizumab or with other approved anti-cancer therapies, in participants with advanced solid tumours.",[64,594,298,595,596,597,598,599,28,600,297,601,602,603],"Prostatic Neoplasms, Castration-Resistant","Esophageal Neoplasms","Head and Neck Neoplasms","Colorectal Neoplasms","Pancreatic Neoplasms","Lung Neoplasms","Mesothelioma, Malignant","Kidney Neoplasms","Sarcoma","Pheochromocytomas",[605,606,607,608,609],"EP4 antagonist","Anti-PD-1\u002FPD-L1 agents","PGE2","EP4","COX inhibitor","2025-06-05",{"date":612,"type":38},"2025-06-08",{"date":614,"type":38},"2023-07-13",{"date":190,"type":21},{"name":617,"class":251},"Cancer Research UK",{"id":619,"slug":620,"hasResults":11,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":564,"enrollmentInfo":625,"targetDuration":4,"studyType":22,"phases":627,"briefSummary":628,"conditions":629,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":636,"startDateStruct":638,"completionDateStruct":640,"leadSponsor":642,"locationsCount":252},"100549980","phase-3-multicenter-clinical-trial-on-the-effectiveness-and-safety-of-instillation-of-bcg-and-alternative-bcg-protocols-for-intermediate-and-high-risk-non-muscle-invasive-bladder-cancer-100549980","NCT06441110","Multicenter Clinical Trial on the Effectiveness and Safety of Instillation of BCG and Alternative BCG Protocols for Intermediate and High-risk Non-muscle Invasive Bladder Cancer","Multicentre Clinical Trial of the Efficacy and Safety of Tislelizumab in Combination With BCG Bladder Instillation in the Prevention of Postoperative Recurrence in Intermediate and High-risk Non-muscle Invasive Bladder Cancer","Inclusion Criteria:\n\n1. Voluntary participation in the trial with signed informed consent;\n2. Patients aged ≥18 and ≤75 years, regardless of gender, with an expected survival of ≥2 years;\n3. Histologically confirmed non-muscle-invasive bladder urothelial carcinoma with positive PD-L1 expression. According to the 2014 guidelines of the Chinese Urological Association (CUA), patients are assessed as having a medium to high risk of recurrence or progression. (For patients considering a second transurethral resection, they may be included in the study after completing the procedure and if pathology confirms medium to high risk non-muscle-invasive bladder urothelial carcinoma);\n4. Performance status score (Eastern Cooperative Oncology Group, ECOG) of 0-2;\n5. Completion of screening-related examinations (complete blood count, coagulation function, liver and kidney function, infectious disease screening, 12-lead ECG, urinary system ultrasound, pelvic MR, and tissue pathology examination), without surgical contraindications.\n\nExclusion Criteria:\n\n1. Any of the following conditions:\n\n   Immune deficiency or impairment (such as AIDS patients), current use of immunosuppressive drugs or radiation therapy that may cause systemic BCG disease reaction; allergy to BCG components; patients with fever and acute infectious diseases, including active tuberculosis or those undergoing anti-tuberculosis treatment; those with severe chronic cardiovascular or cerebrovascular diseases or chronic kidney disease;\n2. Concurrent urogenital system tumors or tumors in other organs;\n3. Muscle-invasive bladder urothelial carcinoma (stage T2 and above) patients;\n4. Patients who have received chemotherapy, radiotherapy, or immunotherapy within the past 4 weeks (except immediate postoperative bladder instillation chemotherapy);\n5. Pregnant or lactating women, women of childbearing age not using effective contraception, or those planning to conceive during the trial period (including male participant partners);\n6. Known or suspected intraoperative bladder perforation;\n7. Presence of gross hematuria prior to enrollment, suspected unhealed surgical wounds or damaged urinary mucosa;\n8. Severe urethral stricture preventing cystoscopy, history of bladder contracture, or functional bladder volume less than 100mL;\n9. Accompanying cystitis, or those who have received other bladder instillation medications and have severe bladder irritation signs expected to affect the assessment of this study;\n10. Patients with various mental disorders, severe coagulation function, liver and kidney function, hematopoietic function disorders, etc., that cannot tolerate surgical treatment;\n11. Participation in other drug clinical trials within 3 months before enrollment;\n12. Known or suspected opioid or alcohol dependence;\n13. Any condition that the researcher believes may increase the risk to the participant or interfere with the execution of the clinical trial.",{"count":626,"type":21},76,[24],"Previous studies have reported the efficacy of Bacillus Calmette-Guérin (BCG) combined with other drugs for the treatment of bladder cancer. However, research on the combination of tislelizumab and BCG for bladder cancer treatment has largely been retrospective. Currently, ongoing clinical trials have not discussed the effectiveness of PD-1\u002FPD-L1 inhibitors combined with BCG instillation in reducing postoperative recurrence in intermediate-risk NMIBC. Therefore, this study aims to explore the clinical efficacy and safety of tislelizumab combined with BCG in the treatment of intermediate and high-risk NMIBC. For this purpose, investigators have established strict screening criteria to include eligible patients in the study and have recruited suitable patients from multiple medical centers.Investigators have also developed a meticulous implementation process and follow-up considerations, hoping to better verify the clinical efficacy and safety of the combined use of these two drugs.",[28,630,631,632,633,634],"BCG Vaccine","Immunotherapy, Active","Multicenter Study","Treatment Outcome","Neoplasm Recurrence, Local","2024-06-03",{"date":637,"type":38},"2024-06-04",{"date":639,"type":38},"2023-06-01",{"date":641,"type":21},"2035-06-01",{"name":643,"class":251},"Fujian Medical University Union Hospital",{"id":645,"slug":646,"hasResults":11,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":650,"eligibilityCriteria":651,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":501,"enrollmentInfo":652,"targetDuration":4,"studyType":414,"phases":4,"briefSummary":654,"conditions":655,"keywords":656,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":252},"100360479","prospective-sample-collection-for-cancer-of-bladder-100360479","NCT03973671","Prospective Sample Collection for Cancer of Bladder","Flemish Prospective Clinical and Pathological Database for Urothelial Cancer","ProCaB","Inclusion Criteria:\n\n* who are aged between 18-90,\n* who are of male or female sex,\n* who give their informed consent to collect their clinical and pathological data,\n* who are planned to undergo TURBT for BC,\n* who are planned to undergo (salvage) radical cystectomy with or without an extended pelvic lymph node dissection,\n* who are planned to undergo tumor biopsy (from primary or metastatic tumor),\n* who are planned to undergo radical nephroureterectomy ± partial cystectomy or segmental ureterectomy, with or without a lymph node dissection,\n* who are planned to undergo endoscopic tumor biopsy or resection,\n* from whom metastases will be surgically removed.\n\nExclusion Criteria:\n\n* patients who do not give their informed consent to collect their clinical and pathological data,\n* patients who withdraw their informed consent to use their clinical and pathological data,\n* patients who refuse the planned treatment,\n* women who are pregnant or have suspicion of pregnancy.",{"count":653,"type":21},300,"The goal of the Flemish Databank for Urothelial Cancer is to collect clinical and pathological data of patients treated for urothelial cancer (UC).",[28],[657,658,659,660,661],"Risk stratification","Recurrence","Progression","Non-muscle-invasive bladder cancer","Muscle-invasive bladder cancer","2024-03-26",{"date":664,"type":38},"2024-03-28",{"date":666,"type":38},"2020-05-29",{"date":668,"type":21},"2032-05",{"name":670,"class":251},"Universitaire Ziekenhuizen KU Leuven",{"id":672,"slug":673,"hasResults":11,"nctId":674,"briefTitle":675,"officialTitle":676,"acronym":4,"eligibilityCriteria":677,"healthyVolunteers":11,"sex":678,"minAge":679,"maxAge":564,"enrollmentInfo":680,"targetDuration":4,"studyType":22,"phases":682,"briefSummary":683,"conditions":684,"keywords":688,"overallStatus":266,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":697,"locationsCount":252},"100464247","urinary-continence-of-female-poprc-and-oin-100464247","NCT05325216","Urinary Continence of Female POPRC and OIN","Urinary Continence of Female Pelvic Organ-preserving Radical Cystectomy and Orthotopic Ileal Neobladder: A Randomized Controlled Study","Inclusion Criteria:\n\n1. Female patients aged between 55-75.\n2. Patients those who are diagnosed with organ-confined urothelial carcinoma（\\\u003CpT3）\n3. Patients those who are capable for radical cystectomy with orthotopic ileal neobladder.\n4. ECOG score between 0-2;\n5. Normal renal function;\n6. Patients those who volunteer to participate in this study and sign the informed consents.\n7. Patients those who are able to cooperate in the study.\n\nExclusion Criteria:\n\n1. Absence of tumour in bladder neck or urethra;\n2. Patients thsoe who are diagnosed distant metastasis before surgery.\n3. Previous history of malignancy of pelvic organs or surgical resection of pelvic organs;\n4. Patients those who are diagnosed with other malignancies.;\n5. Patients those who had received pelvic radiotherapy or major pelvic operation.\n6. Pregnancy status;\n7. Any other conditions that the researcher considers to be excluded from this study","FEMALE","55 Years",{"count":681,"type":21},58,[236],"To compare the urinary continence rate and long-term oncological outcomes of pelvic-organ preserving radical cystectomy (POPRC) with orthotopic ileal neobladder (OIN) versus standard radical cystectomy(SRC) with OIN.",[28,685,686,633,687],"Woman","Sexual Dysfunction, Physiological","Urinary Incontinence",[689],"Bladder cancer, Female, Pelvic organ preserving-radical cystectomy, Radical cystectomy, Orthotopic ileal neobladder","2022-04-12",{"date":692,"type":38},"2022-04-13",{"date":694,"type":21},"2022-04",{"date":696,"type":21},"2028-04-01",{"name":698,"class":251},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University"]