[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bladder-urothelial-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bladder-urothelial-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,48,78,106,127,152,177,211,237,257,284,315],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100624850","phase-2-a-study-of-radiation-therapy-and-cemiplimab-with-or-without-fianlimab-in-people-with-bladder-cancer-100624850",false,"NCT07414992","A Study of Radiation Therapy and Cemiplimab With or Without Fianlimab In People With Bladder Cancer","Neoadjuvant STereotActic Body Radiotherapy and Cemiplimab With or Without Fianlimab for Cisplatin-Ineligible or Cisplatin-Declining Patients With Muscle-Invasive Bladder Cancer (NeoSTAR Bladder)","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of informed consent\n* ECOG 0-1\n* Histologically confirmed diagnosis of urothelial carcinoma.\n\n  ° Variant histology is acceptable if there is a predominant urothelial component. Any neuroendocrine \u002F small cell components are excluded (Investigators are encouraged to discuss with study team and PI)\n* Cystoscopically and radiographically confirmed cT2-4a cN0 cM0 disease per American Joint Committee on Cancer Staging Manual, 8th edition.\n\n  * Patients with cT4a disease invading into the prostatic stroma with no cystoscopic confirmation of muscle invasion are eligible.\n  * Clinically node-negative pelvis (cN0) on CT or MRI within 56 days: no pelvic lymph node ≥15 mm short-axis. Pelvic nodes 10-14 mm are permitted if not suspicious by GU radiology morphology; if deemed suspicious, biopsy or repeat imaging in 4-6 weeks must confirm cN0 prior to enrollment. PET may inform adjudication but is not required.\n* Patients declines cisplatin-based therapy or is ineligible for cisplatin-based therapy based on any of the following criteria:\n\n  * Estimated or calculated creatinine clearance ≥ 30ml\u002Fmin but \\\u003C 60 ml\u002Fmin\n  * Grade 2 or above audiometric hearing loss (per CTCAE v5.0)\n  * Grade 2 or above peripheral neuropathy (per CTCAE v5.0)\n* Availability of tumor specimen block or 20 unstained slides from diagnosis of muscle-invasive disease. Patients with fewer than 20 slides available may be enrolled after discussion with the Principal Investigator.\n* Medically appropriate candidate for radical cystectomy, as per MSK Attending Urologic Oncologist\n* Life expectancy ≥ 12 weeks at randomization\n* Required initial laboratory values:\n\n  * Absolute neutrophil count ≥ 1.0 x 10\\^9\u002FL\n  * Platelets ≥ 100 x 10\\^9\u002FL\n  * Bilirubin ≤1.5 times the upper limit of normal (x ULN)\n  * AST and ALT ≤ 3 x ULN\n  * Partial thromboplastin time (PTT)\u002Fprothrombin time (PT) ≤1.5 x ULN or international normalized ratio (INR) \\\u003C 1.7 x ULN for patients who are not receiving therapeutic anticoagulation. Patients receiving therapeutic anticoagulation should be on a stable dose.\n* For women of childbearing potential: agreement to remain abstinent (i.e., refrain from heterosexual intercourse) or use contraception, as defined below:\n\n  * Women must remain abstinent or use non-hormonal contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period plus 6 months after the last dose of cemiplimab with or without fianlimab.\n  * Examples of non-hormonal contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, and copper intrauterine devices\n  * A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a woman with a tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n* Male subjects must be willing to use contraception during the study and until 6 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Evidence of metastatic disease on standard staging CT and\u002For MR imaging\n* Evidence of nodal metastasis (cN+), defined as any pelvic node ≥15 mm short-axis on CT\u002FMRI or biopsy-proven nodal disease of any size.\n* Prior systemic chemotherapy or non-BCG immunotherapy (e.g., T cell co-stimulation or targeting of immune checkpoint pathways with anti-PD-1, anti-PD-L1, anti-LAG-3, anti-PD-L2, anti-CTLA-4, anti-CD137, IL-15 superagonist, or other medicines specifically targeting T cells other than prior IL-2 therapy) for the treatment of bladder cancer\n* Prior therapy with intravesical BCG within 6 weeks of treatment.\n* Prior pelvic RT\n* Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.\n* Patients using immunosuppressive doses (≥ 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement will not be eligible for the study. It is recommended that patients do not receive systemic corticosteroids such as hydrocortisone, prednisone, prednisolone (Solu-Medrol®) or dexamethasone (Decadron®) at any time throughout the study except in the case of a life-threatening emergency and\u002For to treat an immune-mediated adverse event.\n\n  °Immunosuppressive doses (≥ 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement must be discontinued within 14 days of initiating neoadjuvant SBRT.\n* Received a live vaccine within 30 days of planned start of study medication.\n\n  * Live or live attenuated vaccination with replicating potential. If a patient intends to receive a COVID-19 vaccine before the start of study drug, participation in the study should be delayed at least 1 week after any COVID-19 vaccination. During treatment period, it is recommended to delay COVID-19 vaccination until patients are receiving and tolerating a steady dose of study drug. A vaccine dose should not be less than 48 hours before or after study drug dosing.\n  * Live vaccines are also prohibited during neoadjuvant therapy and for 90 days after completing neoadjuvant therapy.\n* Has had an allogenic tissue\u002Fsolid organ transplant\n* Unstable angina.\n* New York Heart Association (NYHA) Grade II or greater congestive heart failure.\n* History of myocardial infarction within 6 months.\n* History of stroke within 6 months.\n* Evidence of bleeding diathesis or coagulopathy. Therapeutic anticoagulation is permitted, but patients must be on a stable dose.\n* Major surgical procedure within 28 days prior to the study other than transurethral resection of bladder tumor.\n* Serious, non-healing wound, ulcer, or bone fracture.\n* Other prior malignancy active within the previous 2 years except for local or organ-confined early-stage cancer that has been definitively treated with curative intent or does not require treatment, does not require ongoing treatment, has no evidence of active disease, and has a negligible risk of recurrence and is therefore unlikely to interfere with the endpoints of the study.\n* Uncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.\n* Notes:\n\n  * Patients with known HIV who have controlled infection (undetectable viral and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.\n  * Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.\n  * Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n  * Patients with HIV or hepatitis must be reviewed by a qualified specialist (e.g., infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial.\n* Participants with a history of myocarditis.\n* Troponin T (TnT) or troponin I (TnI) \\> 2x institutional ULN at baseline.\n\n  * TnT or Tnl levels between \\> 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN.\n  * If TnT or Tnl levels are \\> 1 to 2x ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on the judgement in the patient's best interest.\n* Known hypersensitivity to the active substances or to any of the excipients.\n* WOCBP\\* must have a negative serum (beta-hCG) at screening.\n\n  * WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.\n\n    * A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to the CTFG guidance.\n\nPregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.\n\n* Male study participants with WOCBP partners are required to use condoms during the study and until 6 months after the last dose of study treatment unless they are vasectomized or practice sexual abstinence.\n* Vasectomized partner or vasectomized study participant must have received medical assessment of the surgical success.\n* Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.\n\n  * WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and until 6 months after last treatment\n  * All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose\n  * Pregnant or breastfeeding women.\n  * Women of childbearing potential (WOCBP)\\* who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:\n* stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening;\n* intrauterine device; intrauterine hormone-releasing system;\n* bilateral tubal occlusion\u002Fligation;\n* vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and\u002For\n* sexual abstinence\n* Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.\n* Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.\n\n  * Active infection requiring therapy.\n  * Subjects who are compulsorily detained for treatment of a psychiatric illness.\n  * History or current evidence of significant (CTCAE grade ≥ 2) local or systemic infection (e.g, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.","ALL","18 Years",{"count":19,"type":20},44,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The researchers are doing this study to find out whether stereotactic body radiation therapy (SBRT) in combination with immunotherapy (cemiplimab with or without fianlimab) before cystectomy is an effective and safe treatment for people with muscle-invasive bladder cancer (MIBC).",[26],"Bladder Urothelial Carcinoma",[28,29,30,31,32,33,34],"Cemiplimab","Fianlimab","Bladder cancer","Muscle-invasive bladder cancer","Cystectomy","Radiotherapy","25-328","NOT_YET_RECRUITING","2026-08-17",{"date":38,"type":39},"2026-08-18","ACTUAL",{"date":41,"type":20},"2026-09",{"date":43,"type":20},"2028-03",{"name":45,"class":46},"Memorial Sloan Kettering Cancer Center","OTHER",7,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100651068","bladder-sparing-treatment-with-disitamab-vedotin-and-toripalimab-with-or-without-pelvic-lymph-node-dissection-in-bladder-cancer-100651068","NCT07756008","Bladder-Sparing Treatment With Disitamab Vedotin and Toripalimab With or Without Pelvic Lymph Node Dissection in Bladder Cancer","A Prospective, Multicenter, Randomized Controlled Study of Disitamab Vedotin Plus Toripalimab With or Without Pelvic Lymph Node Dissection for Bladder-Sparing Treatment in Patients With cT2-3N0M0 Bladder Urothelial Carcinoma","Inclusion Criteria:\n\n1. Male or female participants aged 18 years or older.\n2. Histologically confirmed bladder urothelial carcinoma.\n3. Clinical stage cT2-3N0M0 according to the AJCC 8th edition TNM staging system.\n4. HER2 expression of IHC 2+ or higher.\n5. Participants who decline radical cystectomy as assessed by the investigator.\n6. Adequate organ function as defined in the study protocol.\n7. Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to disitamab vedotin, toripalimab, their excipients, or other monoclonal antibodies.\n2. Prior radiotherapy for bladder cancer.\n3. Prior anticancer treatment that may affect efficacy assessment, as defined in the study protocol.\n4. Pregnant or breastfeeding women.\n5. Any serious uncontrolled disease or medical condition that, in the investigator's judgment, would make participation inappropriate.\n6. Participation in another interventional clinical trial that may interfere with this study.",{"count":56,"type":20},114,[23,58],"PHASE3","This is a prospective, multicenter, randomized controlled superiority study designed to evaluate whether the addition of pelvic lymph node dissection improves bladder-intact event-free survival in patients with cT2-3N0M0 bladder urothelial carcinoma receiving bladder-sparing treatment. Eligible patients with HER2 expression of IHC 2+ or higher who decline radical cystectomy will be randomized 1:1 to receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab with or without standardized pelvic lymph node dissection. The primary endpoint is the 2-year bladder-intact event-free survival rate. Secondary endpoints include clinical complete response, partial response, disease progression, overall survival, quality of life, safety, treatment cost, and exploratory biomarker analyses.",[26,61,62],"Muscle-invasive Bladder Cancer","Bladder Cancer",[64,65,66,67],"Bladder-sparing therapy","Disitamab vedotin","Toripalimab","Pelvic lymph node dissection","2026-08-04",{"date":70,"type":39},"2026-08-10",{"date":72,"type":20},"2026-08-01",{"date":74,"type":20},"2031-06-20",{"name":76,"class":46},"Tianjin Medical University Second Hospital",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":77},"100648055","phase-2-sun-yat-sen-treatment-strategy-for-enhancing-response-in-muscle-invasive-bladder-cancer-100648055","NCT07717242","Sun Yat-Sen Treatment Strategy for Enhancing Response in Muscle-invasive Bladder Cancer","Study on Immunotherapy Enhancement Strategies for Muscle-invasive Bladder Cancer","SYSTEM","Inclusion Criteria:\n\n1. Voluntarily participate in this study, provide written informed consent, and be able to understand and agree to comply with the study requirements and assessment schedule.\n2. Age ≥18 years on the date of signing the informed consent form.\n3. Histologically confirmed and radiologically assessed cT2-T4aN0M0 urothelial carcinoma of the bladder according to the American Joint Committee on Cancer (AJCC) 8th edition TNM staging system. For tumors with mixed histology, urothelial carcinoma must be the predominant component (at least 50%).\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. HER2 expression ≥1+ confirmed by immunohistochemistry using a pretreatment tumor specimen tested at a local laboratory.\n6. Availability of tumor tissue obtained from transurethral resection of bladder tumor (TURBT), together with the corresponding pathology report. Fresh surgical tissue or unstained pathology slides may be submitted.\n7. Adequate organ function, as determined by the following screening laboratory values obtained within 14 days before enrollment:\n\n   a. For assessment of the following hematologic parameters, participants must not have received growth factor support within 14 days before sample collection: i. Absolute neutrophil count ≥1.5 × 10\\^9\u002FL; ii. Platelet count ≥90 × 10\\^9\u002FL; iii. Hemoglobin ≥90 g\u002FL. b. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 × the upper limit of normal (ULN).\n\n   c. Total serum bilirubin ≤1.5 × ULN. For participants with Gilbert syndrome or indirect bilirubin elevation of extrahepatic origin, total bilirubin must be ≤3 × ULN.\n\n   d. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤2.5 × ULN.\n\n   e. Pulmonary function indicating ability to tolerate surgery.\n8. Women who are not pregnant or women of childbearing potential must be willing to use highly effective contraception during the study and for at least 120 days after the last dose of disitamab vedotin or toripalimab, whichever occurs later, and must have a negative urine or serum pregnancy test within 7 days before enrollment. Non-sterilized male participants must be willing to use highly effective contraception during the study and for at least 120 days after the last dose of disitamab vedotin or toripalimab, whichever occurs later.\n\nExclusion Criteria:\n\n1. Prior treatment with therapies targeting PD-1, PD-L1, PD-L2, CTLA-4, LAG-3, HER2, or Nectin-4, or with other antibodies or drugs specifically targeting T-cell co-stimulatory or checkpoint pathways.\n2. Receipt of other approved systemic anticancer therapy or systemic immunomodulators, including but not limited to interferon, interleukin-2, or tumor necrosis factor, within 28 days before enrollment.\n3. Prior radiotherapy for bladder cancer.\n4. Prior antitumor drug therapy, except for the following:\n\n   1. For participants who previously received systemic chemotherapy, a treatment-free interval of at least 12 months from the last treatment to the start of neoadjuvant study treatment is required.\n   2. Local intravesical chemotherapy or immunotherapy must have been completed at least 1 week before the start of neoadjuvant study treatment.\n5. Major surgery or major trauma within 28 days before enrollment. Placement of a vascular access device and TURBT are not considered major surgery.\n6. Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral treatment within 14 days before enrollment. HBV infection will be assessed according to Exclusion Criterion 13.\n7. Receipt of a live vaccine within 28 days before enrollment. Seasonal injectable influenza vaccines are generally inactivated and are permitted; intranasal vaccines are live vaccines and are not permitted.\n8. Active autoimmune disease requiring systemic treatment and considered by the investigator to affect study treatment.\n9. Requirement for long-term high-dose corticosteroids or other immunosuppressive agents considered by the investigator to affect study treatment.\n10. Any history of uncontrolled systemic disease that, in the investigator's judgment, may affect treatment, including abnormal potassium, sodium, or calcium levels; hypoalbuminemia; interstitial lung disease; noninfectious pneumonitis; diabetes mellitus; hypertension; cardiovascular disease; or other uncontrolled systemic disease.\n11. For Arm A, any of the following:\n\n    1. Treatment with a DPP-4 inhibitor within 60 days before the first administration of study treatment.\n    2. Diabetes mellitus requiring any glucose-lowering medication, including long-acting or short-acting insulin, DPP-4 inhibitors, GLP-1 receptor agonists, or other glucose-lowering drugs.\n    3. Fasting blood glucose \\\u003C4 mmol\u002FL.\n12. For Arm D, any of the following:\n\n    1. Acute cholecystitis or cholangitis.\n    2. Biliary obstruction.\n    3. Recurrent biliary colic attacks.\n    4. Radiopaque calcified gallstones.\n    5. Impaired gallbladder function.\n    6. Nonvisualization of the gallbladder on radiography.\n13. Untreated chronic hepatitis B or hepatitis B virus carrier status with HBV DNA ≥500 IU\u002FmL (2500 copies\u002FmL). Participants with inactive hepatitis B surface antigen carrier status or stable active HBV infection after continuous antiviral therapy, with HBV DNA \\\u003C500 IU\u002FmL, may be enrolled. HBV DNA testing is required only for participants positive for hepatitis B core antibody.\n14. Active hepatitis C. Participants with negative HCV antibody results, or participants with positive HCV antibody results but negative HCV RNA results during screening, may be enrolled. HCV RNA testing is required only for participants with positive HCV antibody results.\n15. History of immunodeficiency, including positive human immunodeficiency virus (HIV) testing, other acquired or congenital immunodeficiency disorders, prior allogeneic stem cell transplantation, or prior organ transplantation.\n16. Known allergy to other monoclonal antibodies.\n17. Known allergy to any study drug or excipient.\n18. Toxicities from any prior treatment that have not recovered to baseline or a stable level, unless the investigator determines that such toxicities are unlikely to pose a safety risk, for example alopecia, neuropathy, or specific laboratory abnormalities.\n19. Any underlying medical condition, alcohol or drug abuse, or dependence that may interfere with study drug administration, affect interpretation of study results, or place the participant at high risk of treatment complications.\n20. Concurrent participation in another interventional clinical study.",{"count":87,"type":20},80,[23],"This is a multicenter, prospective, open-label, Phase II, four-arm parallel study evaluating the efficacy and safety of different sensitization strategies combined with disitamab vedotin and toripalimab in patients with HER2-positive muscle-invasive urothelial carcinoma of the bladder (MIBC).\n\nEligible patients with cT2-4aN0M0 HER2-positive urothelial carcinoma of the bladder will receive neoadjuvant disitamab vedotin plus toripalimab in combination with one of four sensitizing agents: sitagliptin, tazemetostat, tafolecimab, or ursodeoxycholic acid.\n\nAfter six cycles of neoadjuvant treatment, patients will undergo comprehensive response assessment, including imaging, cystoscopy, urine cytology, and complete transurethral resection of bladder tumor (cTURBT). Patients who achieve a clinical complete response (cCR) may enter a bladder-preservation treatment pathway, including additional disitamab vedotin plus toripalimab and subsequent toripalimab maintenance therapy. Patients who do not achieve cCR will be considered for salvage radical cystectomy.\n\nThe primary objective is to evaluate the cCR rate of each treatment strategy. Secondary objectives include bladder-intact disease-free survival, overall survival, bladder preservation rate, safety, quality of life, treatment costs, and exploratory biomarker analyses.",[26,62],[92,62,93,94,66,95],"Urothelial Carcinoma","Bladder Preservation Therapy","Disitamab Vedotin","RC48","RECRUITING","2026-07-16",{"date":99,"type":39},"2026-07-21",{"date":101,"type":20},"2026-07-01",{"date":103,"type":20},"2029-01-31",{"name":105,"class":46},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":77},"100595192","ultrasound-guided-core-needle-biopsy-to-stage-urothelial-carcinoma-of-the-bladder-us-ucb-100595192","NCT07029256","Ultrasound-Guided Core Needle Biopsy to Stage Urothelial Carcinoma of the Bladder (US UCB)","Ultrasound-Guided Core Needle Biopsy to Stage Urothelial Carcinoma of the Bladder","Inclusion Criteria:\n\n* Undergoing radical cystectomy for confirmed or suspected urothelial carcinoma of the bladder\n* Prior abdominal imaging\n\nExclusion Criteria:\n\n* History of partial cystectomy or complex bladder reconstruction or substitution (i.e. bladder augment or urothelial recurrence in a neobladder)",{"count":114,"type":20},100,"OBSERVATIONAL","This study is being done to test the feasibility and accuracy of using an ultrasound-guided core needle biopsy technique as a potential tool for staging urothelial carcinoma of the bladder (UCB).",[26],"2026-06-08",{"date":120,"type":39},"2026-06-10",{"date":122,"type":39},"2024-07-26",{"date":124,"type":20},"2030-07-30",{"name":126,"class":46},"Mayo Clinic",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100536309","phase-2-futibatinib-in-combination-with-durvalumab-prior-to-cystectomy-for-the-treatment-of-muscle-invasive-bladder-cancer-patients-who-are-ineligible-for-cisplatin-based-therapy-100536309","NCT06263153","Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy","A Phase II Trial of Futibatinib in Combination With Durvalumab (MEDI4736) Administered to Cisplatin-Ineligible Patients With Muscle-Invasive Bladder Cancer Before Cystectomy","Inclusion Criteria:\n\n* Able to provide signed informed consent\n* Female or male subjects \\>= 18 years old\n* Bodyweight \\>30kg\n* FGFR1, 2, or 3 overexpression as defined by a score of 3+ or 4+ on ribonucleic acid (RNA) in-situ hybridization (RNAScope assay)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Histologically confirmed urothelial carcinoma of the bladder\n\n  * Mixed histologies are permitted if urothelial carcinoma is the predominant histology ( \\>= 50%)\n* Clinical stage T2-T4a, N0, M0 disease by trans urethral removal of bladder tumour (TURBT) and imaging studies (stage II-IIIA per American Joint Committee on Cancer \\[AJCC\\] 2018)\n* Refuse or ineligible for cisplatin-based neoadjuvant chemotherapy as defined by any of the following:\n\n  * ECOG performance status (PS) \\> 1\n  * Creatinine clearance (calculated or measured) \\\u003C 60 mL\u002Fmin as measured by the Cockcroft-Gault formula\n  * Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v 5.0) grade \\>= 2 hearing loss\n  * CTCAE v 5.0 grade \\>= 2 neuropathy\n  * New York Heart Association (NYHA) class \\> II cardiac dysfunction\n* Treatment with anti-PD-1\u002FPD-L1 therapy for non-muscle invasive bladder cancer (NMIBC) is permitted if it is completed \\> 3 months before registration\n* Eligible for radical cystectomy by the following:\n\n  * Fit and planned for radical cystectomy according to local guidelines\n* Archival transurethral resection of bladder tumor (TURBT) tissue submission must be 30 unstained slides. If archival tissue is unavailable, the patient must undergo cystoscopy and biopsy. The tumor sample must contain at least 20% viable tumor\n* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female premenopausal patients.\n* Female subjects of childbearing potential and male subjects must be willing to completely abstain or agree to use a highly effective method of contraception (i.e., less than 1% failure rate), from the time of signing informed consent and for the duration of study participation through 90 days following the last dose of study drug.\n* Hemoglobin \\>= 9.0 g\u002FdL\n* Absolute neutrophil count (ANC) \\> 1500 per mm\\^3\n* Platelet count \\>= 100 x 10\\^9\u002FL\n* International normalized ratio (INR) or activated partial thromboplastin time (aPTT) \\\u003C 1.5 × upper limit of normal (ULN), unless the patient is receiving anticoagulation therapy provided INR or PTT is within the therapeutic range of the intended anticoagulant therapy\n* Serum bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional upper limit of normal\n* Phosphorus ≤ institutional upper limit of normal (ULN)\n* Measured creatinine clearance (CL) \\> 30 mL\u002Fmin or calculated creatinine CL \\> 30 mL\u002Fmin by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n* Must have a life expectancy of at least 12 weeks\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding\n* Male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy\n* Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks before the first dose of trial treatment\n* Has upper tract urothelial carcinoma\n* Has small-cell carcinoma component on histology\n* Evidence of measurable nodal or metastatic disease\n* Concurrent anticancer therapy (e.g., chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, intravesical therapy, or tumor embolization)\n* Received prior systemic chemotherapy for muscle-invasive bladder cancer at any time in the patient's medical history\n* Has received anti-PD-1\u002FPD-L1 therapy or FGFR inhibitor previously for MIBC, except if used in earlier stage urothelial carcinoma such as non-muscle invasive bladder cancer (NMIBC) and completed \\> 3 months prior to registration\n\n  * Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n  * All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.\n  * Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE: Patients with endocrine AE of ≤Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n  * Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \\> 10 mg prednisone or equivalent per day.\n* Underwent major surgery and has not recovered adequately from the intervention's toxicity and\u002For complications before starting therapy\n* Has an active second malignancy except for low-risk localized prostate cancer on \"watch and wait\"\n* Subjects with a history of malignancy that has been completely treated, with no evidence of active cancer for 2 years before enrollment, or subjects with surgically cured tumors with a low risk of recurrence are allowed to enroll at PI's discretion (e.g. adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease and effectively treated carcinoma in situ without evidence of disease).\n* Has active cardiac disease, defined as:\n\n  * Myocardial infarction or unstable angina pectoris within 3 months of the first date of study therapy\n  * Unstable arrhythmias\n  * Decompensated heart failure\n  * Uncontrolled hypertension and unstable angina pectoris\n  * Average QT corrected by the Fridericia formula (QTcF) \\> 470 msec (males and females) (Note: If the QTcF is \\> 470 msec in the first electrocardiography \\[ECG\\], a total of 3 ECGs separated by \\>= 5 minutes should be performed. If the average of these 3 consecutive results for QTcF is =\\\u003C 470 msec, the subject meets eligibility in this regard.)\n* Has any medical condition that may prevent the patient from undergoing radical cystectomy\n* Must be at least 2 weeks beyond high-dose systemic corticosteroids; chronic steroid use up to 10 mg daily prednisone (or equivalent), intranasal, inhaled, topical steroids, local steroid injections (e.g., intra articular injection), steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) are permitted\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\n  * Patients with vitiligo or alopecia\n  * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Patients without active disease in the last 5 years may be included but only after consultation with the study physician\n  * Patients with celiac disease controlled by diet alone\n* Has a known history of HIV-1\u002F2 with detectable viral load and\u002For CD4 count \\\u003C 300\u002FmL within the previous 3 months or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n* Has detectable hepatitis B virus (HBV) or hepatitis C virus (HCV) viral load polymerase chain reaction (PCR) if there is a known history of active hepatitis B or hepatitis C\n* History and\u002For current evidence of significant ectopic mineralization\u002Fcalcification including but not limited to the soft tissues, kidneys, intestines, myocardium, and lungs, except calcified lymph nodes and asymptomatic coronary calcification\n* Current evidence of corneal or retinal disorder\u002F keratopathy including but not limited to bullous\u002F band keratopathy, corneal abrasion, inflammation\u002Fulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination\n* Have current evidence of endocrine alterations of calcium\u002Fphosphate homeostasis (e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis) unless well controlled\n* Have used drugs that are dual p-glycoprotein and strong CYP3A inducers or inhibitors within 7 days prior to the first dose of the study drug\n* Has other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of the study procedure and follow-up examinations\n* Known allergy or hypersensitivity to study drugs or any excipient.\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product (IP). Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 90days after the last dose of IP.\n* Has other uncontrolled illnesses, ongoing or active infection, or serious chronic gastrointestinal conditions associated with diarrhea\n* Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\n\n  * Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n  * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician\n* History of allogenic organ transplantation",{"count":135,"type":20},24,[23],"This phase II trial tests how well the combination of futibatinib and durvalumab given before cystectomy works in treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based therapy. Cisplatin-based therapy is the standard of care for patients with MIBC. However, many patients cannot receive standard therapy due to poor renal function, peripheral neuropathy, poor functional status, or clinically significant heart failure. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Radical cystectomy is a surgery to remove all of the bladder as well as nearby tissues and organs. Giving futibatinib in combination with durvalumab before surgery may be an effective treatment option for patients with MIBC who are ineligible for cisplatin-based therapy.",[26,139,140,141],"Muscle Invasive Bladder Carcinoma","Stage II Bladder Cancer AJCC v8","Stage IIIA Bladder Cancer AJCC v8","2025-12-15",{"date":144,"type":39},"2025-12-17",{"date":146,"type":39},"2024-12-30",{"date":148,"type":20},"2026-12-31",{"name":150,"class":46},"Yuanquan Yang",3,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":162,"conditions":163,"keywords":164,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":4},"100571973","survival-benefits-of-neoadjuvant-systemic-chemotherapy-in-muscle-invasive-bladder-cancer-100571973","NCT06727214","Survival Benefits of Neoadjuvant Systemic Chemotherapy in Muscle Invasive Bladder Cancer","Survival Benefit of Neoadjuvant Systemic Chemotherapy in Muscle Invasive Bladder Cancer and Factors Affecting Its Response - Retrospective Study","AssiutU","Inclusion Criteria:\n\n* Age \\>18\n* histological proven MIBC patient treated with neoadjuvant systemic chemotherapy( platinum based )\n\nExclusion Criteria:\n\n* Non muscle invasive bladder cancer (NMIBC)\n* Metastatic patients\n* Patients treated with surgery firstly",{"count":161,"type":20},87,"Muscle-invasive bladder cancer (MIBC) is an aggressive disease with a high-risk of early metastasis and cancer specific mortality. The gold standard treatment of MIBC is radical cystectomy (RC) in conjunction with concomitant bilateral pelvic lymphadenectomy . While radical cystectomy remains a primary management strategy for MIBC, high rates of recurrence with surgery alone highlight the likelihood of occult micrometastatic disease at the time of diagnosis. Due to the development and implementation of neoadjuvant chemotherapy prior to radical cystectomy, the prognosis for MIBC patients undergoing radical cystectomy has improved .",[26],[165,166,167],"survival benefits","neoadjuvant CTH","bladder cancer","2025-09-29",{"date":170,"type":39},"2025-09-30",{"date":172,"type":20},"2025-11-04",{"date":174,"type":20},"2026-12-01",{"name":176,"class":46},"Sara Mahmoud Ahmed Mahmoud",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":188,"conditions":189,"keywords":198,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":77},"100462046","phase-1-anti-ny-eso-1-tcr-gene-engineered-lymphocytes-given-by-infusion-to-patients-with-ny-eso-1--expressing-metastatic-cancers-100462046","NCT05296564","Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers","A Phase I\u002FII Dose Escalation, Safety and Efficacy Study of Anti-NY-ESO-1 T Cell Receptor (TCR)-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers","Inclusion Criteria:\n\n1. Have histologically or cytologically confirmed diagnosis of neoplasia\n2. Measurable (per RECIST v1.1 criteria) metastatic cancer or locally advanced refractory\u002Frecurrent malignancy not amenable to curative treatment. Lesions previously irradiated may be considered measurable only if growth has been documented since local treatment completion.\n3. The tumor expresses ESO as assessed immunohistochemistry of resected tissue. To this end, archived tumor tissue suitable for analysis must be available or re-biopsy performed on study. Tissue staining must encompass more than 10% of tumor section.\n4. Patients must have previously either (1) received at least first-line or second-line standard therapy for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease), intolerable or have recurred or (2) Recurred within 6 months of adjuvant systemic therapy known to be active also in the metastatic setting.\n5. Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.\n6. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo).\n7. Age ≥ 18 years and ≤ 70 years.\n8. Patient is able to understand and willing to sign a written informed consent.\n9. Clinical performance status of ECOG 0, 1 or 2.\n10. HLA-A\\*0201or A\\*0206 positive.\n11. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment.\n12. Women of child-bearing potential must have a negative pregnancy test.\n13. Serology: Seronegative for HIV antibody, hepatitis B antigen, and hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n14. Hematology\n\n    * ANC \\> 1500\u002Fmm3 without the support of filgrastim\n    * WBC ≥ 3000\u002Fmm3\n    * Platelet count ≥ 100,000\u002Fmm3\n    * Hemoglobin \\> 8.0 g\u002FdL. Subjects may be transfused to reach this cut-off.\n15. Chemistry\n\n    * Serum ALT\u002FAST ≤ 2.5 x ULN\n    * Creatinine clearance ≥40ml\u002Fmin\n    * Total bilirubin ≤ 1.5 mg\u002FdL, except in patients with Gilbert's Syndrome, who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    * INR \\\u003C 1.5\n\nExclusion Criteria:\n\n1. Women of child-bearing potential who are pregnant or breastfeeding.\n2. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).\n3. Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses\n4. Concurrent systemic steroid therapy, not including replacement therapy or treatment with prednisone up to 10mg daily or its equivalent. Or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention.\n5. History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.\n6. Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within 3 months.\n7. Subjects unable to maintain normal oxygen saturation level in room air.\n8. Subjects who have had a venous thromboembolic event requiring anticoagulation and who meet any of the following criteria:\n\n   * Have been on a stable dose of anticoagulation for \\\u003C 1 month (except for acute line insertion induced thrombosis).\n   * Have had a Grade 2, 3, or 4 hemorrhage in the last 30 days or are experiencing continued symptoms from their venous thromboembolic event (e.g. continued dyspnea or oxygen requirement).\n9. Has a known additional malignancy within the last 3 years. Exceptions include early stage cancers (carcinoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy).\n10. LVEF ≤ 40%\n11. Documented FEV1 ≤ 60% predicted tested in patients with:\n\n    * A prolonged history of cigarette smoking (≥ 20 pack-year smoking history, with cessation within the past two years).\n    * Symptoms of respiratory dysfunction.\n12. Patients who are at the time of study initiation receiving any other investigational agents.\n13. Carcinomatosis meningitis or other brain involvement exceeding that allowed above.\n14. Has received live vaccine within 30 days before the first dose of study intervention. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.","70 Years",{"count":151,"type":20},[187,23],"PHASE1","A Phase I\u002FII Dose Escalation, Safety and Efficacy Study of HBI 0201-ESO TCRT (anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes) Given by Infusion to Patients with NY-ESO-1 -Expressing Metastatic Cancers",[190,191,192,193,194,195,26,196,197],"Sarcoma, Synovial","Sarcoma,Soft Tissue","Melanoma Stage IV","Triple Negative Breast Cancer","Metastatic Cancer","Non Small Cell Lung Cancer","Neuroblastoma, Metastatic","Ovary Cancer",[199,200,201,202],"NY-ESO-1","TCR","adoptive transfer","retroviral transduction",{"date":204,"type":39},"2025-10-02",{"date":206,"type":39},"2022-04-01",{"date":208,"type":20},"2027-12-30",{"name":210,"class":46},"Hadassah Medical Organization",{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":21,"phases":221,"briefSummary":222,"conditions":223,"keywords":224,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":236},"100406633","phase-3-neoadjuvant-upper-tract-invasive-cancer-trial-nautical-100406633","NCT04574960","Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)","Neoadjuvant Chemotherapy in Upper Tract Urothelial Cancer: A Multicentre, Feasibility Pilot Trial","NAUTICAL","Inclusion Criteria:\n\n* Newly diagnosed radiographically visible (CT or MRI) cT1-4 N0 M0 with positive selective urinary cytology, positive bladder urinary cytology, or endoscopic biopsy for high grade urothelial cell carcinoma\n* Age ≥18 years of age\n* Eastern Cooperative Oncology Group (ECOG) score 0-1\n* Medically appropriate candidate for radical nephroureterectomy or ureterectomy as per participating site attending urologic oncologist\n* Medically appropriate candidate for cisplatin-based chemotherapy as per participating site attending medical oncologist\n* Adequate organ system function defined as follows: absolute neutrophil count ≥ 1500\u002Fmm3, platelets ≥ 100,00\u002Fmm3, hemoglobin ≥ 90 g\u002FL, ALT and AST \\\u003C 2.5 x upper limit of normal, electrolytes (Na, K, Mg, Ca): within normal limits, GFR ≥ 60 mL\u002Fmin\n\nPatients who are randomized to the adjuvant chemotherapy will be reassessed for suitability to receive adjuvant chemotherapy after definitive surgery (nephroureterectomy or ureterectomy) based on the following criteria:\n\n* pT2-4 N0-3 M0 or pT any N1-3 M0 with predominant urothelial component\n* ECOG score 0-2\n* Medically appropriate candidate for platin-based chemotherapy as per participating site attending medical oncologist\n* Adequate organ system function defined as follows: absolute neutrophil count ≥ 1500\u002Fmm3, platelets ≥ 100,00\u002Fmm3, hemoglobin ≥ 90 g\u002FL, ALT and AST \\\u003C 2.5 x upper limit of normal, electrolytes (Na, K, Mg, Ca): within normal limits, GFR ≥ 30 mL\u002Fmin\n\nExclusion Criteria:\n\n* Metastatic disease\n* Radiographically visible nodal disease\n* Concurrent muscle-invasive bladder cancer (non-muscle invasive bladder cancer is acceptable)\n* Solitary kidney\n* Other cancer diagnosis or systemic chemotherapy use within 2 years of study enrollment (prior bladder cancer and intravesical therapy allowed)\n* Concomitant diseases that are a formal exclusion to cisplatin chemotherapy (deafness, ≥ grade II neuropathy, serious active infection)\n* Concomitant use of any other investigational drugs\n* Pregnancy or breast feeding (you must remain on contraception, not father a child or donate sperm while receiving gemcitabine\u002Fcisplatin and for 6 months following the last dose)",{"count":220,"type":20},14,[58],"Upper tract urothelial cancer (UTUC) is cancer in the lining of the kidney or ureter (the tube that drains the kidney). This type of cancer is rare and as a result, there are only a few studies that have looked at it.\n\nStandard of care for UTUC would be surgery followed by chemotherapy (adjuvant chemotherapy). However, we know from studies that have looked at cancer of the lining of the bladder, which is a similar cancer in many ways, that treating people with chemotherapy before surgery (neoadjuvant chemotherapy) can lead to longer survival compared to the standard of care. There are no studies to show this in UTUC. Neoadjuvant chemotherapy is thought to help improve survival by treating any cancer that may have spread from the original tumour but that is not visible yet on scans. This study would be the first clinical trial in Canada to evaluate the use of chemotherapy before surgery in this disease setting.\n\nSince UTUC is rare, the purpose of this study is to determine if it is possible to enrol enough patients to a trial looking at the use of chemotherapy before surgery.",[62,26],[225,226],"Upper tract urothelial carcinoma","UTUC","2025-07-16",{"date":229,"type":39},"2025-07-20",{"date":231,"type":39},"2021-02-08",{"date":233,"type":20},"2027-12",{"name":235,"class":46},"University Health Network, Toronto",2,{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":4},"100558425","aldoa-expression-in-bladder-urothelial-carcinoma-100558425","NCT06550947","ALDOA Expression in Bladder Urothelial Carcinoma","Immunohistochemical Expression and Prognostic Significance of ALDOA in Bladder Urothelial Carcinoma.","Inclusion Criteria:\n\n* All cases diagnosed as bladder urothelial cancer with known follow-up data and presence of muscle proper detected in the specimens.\n\nExclusion Criteria:\n\n1. Subtypes of bladder cancer other than urothelial carcinoma subtype.\n2. Cases of urothelial carcinoma without known follow up data.\n3. Cases of urothelial carcinoma without muscle proper detected in the specimen.",{"count":245,"type":20},50,"1. Study the immunohistochemical expression of ALDOA in bladder urothelial cancer.\n2. Correlate between ALDOA expression in specimens and different cilnicopathological factors.\n3. Correlate between ALDOA expression and urothelial cancer prognosis and survival.",[26],"2024-08-09",{"date":250,"type":39},"2024-08-13",{"date":252,"type":20},"2024-09",{"date":254,"type":20},"2025-08",{"name":256,"class":46},"Assiut University",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":21,"phases":267,"briefSummary":268,"conditions":269,"keywords":272,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":77},"100556698","phase-2-bladder-preservation-with-sacituzumab-govitecan--zimberelimab-for-muscle-invasive-bladder-cancer-100556698","NCT06528483","Bladder Preservation With Sacituzumab Govitecan + Zimberelimab for Muscle-Invasive Bladder Cancer","Bladder Preservation With Sacituzumab Govitecan + Zimberelimab for Muscle-Invasive Bladder Cancer in Cisplatin-unfit and Unwilling for Cystectomy Patients: Phase II Trial","preSAVE","Inclusion Criteria:\n\n* Participant is at least 18 years old of age, at the time of providing informed consent.\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n* Patients deemed ineligible for Radical Cystectomy (RC) + Retroperitoneal lymphnode dissection (RPNLD) by a urologist and\u002For oncologist and\u002For anesthesiology.\n* Cisplatin unfit patients as per Galsky criteria (ECOG Performance Status of 2 and\u002For creatinine-clearance \\\u003C 60 ml\u002Fmin and\u002For CTCAE Gr ≥ 2 hearing loss and\u002For CTCAE Gr ≥ 2 neuropathy).\n* Cisplatin-fit patients are admitted if they are unwilling to undergo Radical Cystectomy (RC) and unwilling for cisplatin-based chemotherapy.\n* Patients deemed eligible for surgery will be included if they will be unwilling to undergo RC and will be ineligible and\u002For unwilling to cisplatin-based chemotherapy.\n* cT2-cT4 bladder cancer patients with predominant urothelial histology or Squamous cell histologic variant with histological confirmed diagnosis of muscle-invasive bladder cancer (MIBC) obtained via a diagnostic or maximal TURBT performed within 90 days before enrollment.\n* cN0-1 bladder cancer patients with predominant urothelial histology or Squamous cell histologic variant\n* Have adequate organ function as defined as follow (Specimens must be collected within 10 days prior to the start of study intervention):\n\n  * Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study treatment initiations (hemoglobin ≥ 9 g\u002FdL, ANC ≥ 1500\u002Fmm3, and platelets ≥ 100,000\u002FμL).\n  * Adequate hepatic function (bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5 × ULN or ≤ 5 × ULN if known liver metastases, and serum albumin \\> 3 g\u002FdL).\n  * Creatinine clearance ≥ 30 mL\u002Fmin as assessed by the Cockcroft-Gault equation.\n  * International normalized ratio (INR)\u002FPT and PTT or aPTT ≤ 1.5 ULN unless patient is currently receiving therapeutic anticoagulant therapy.\n* Patients with HIV must be on antiretroviral therapy (ART) and have a well-controlled\n\nHIV infection\u002Fdisease defined as:\n\n* Patients on ART must have a CD4+ T-cell count ≥ 350 cells\u002Fmm3 at time of screening.\n* Patients on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies\u002FmL or the lower limit of qualification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to screening.\n* Patients on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to study entry (Day 1).\n* The combination ART regimen must not contain any medications that may interfere with SN-38 metabolism.\n\nExclusion Criteria:\n\n1. Positive serum pregnancy test (Appendices 9.4) or women who are breastfeeding.\n2. Known hypersensitivity to the study drug, its metabolites, or formulation excipient.\n3. Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section.\n4. Have had a prior anticancer biologic agent within 4 weeks prior to enrollment or have had prior chemotherapy or targeted small molecule therapy. Patients participating in observational studies are eligible.\n5. Have previously received topoisomerase 1 inhibitors.\n6. Have an active second malignancy. Note: patients with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or patients with surgically cured tumors with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll. Other exception are localized prostate cancer with a Gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.\n7. Patients with neuroendocrine histology will be excluded.\n8. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment.\n9. Have active serious infection requiring antibiotics.\n10. Have known history of HIV-1 or 2 (or positive HIV-1\u002F2 antibody, if done at screening) with detectable viral load OR taking medications that may interfere with SN-38 metabolism.\n11. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.\n\n    * Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease.\n    * Patients who test positive for HCV antibody. Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Patients with a known history of HCV or a positive HCV antibody test will not require a HCV antibody at screening and will only require HCV RNA by quantitative PCR for confirmation of active disease.\n12. Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.\n13. Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the patient's participation in the study.\n14. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of study drug.",{"count":266,"type":20},63,[23],"Patients with MIBC N0\u002FN1 unwilling or unfit for cystectomy will receive SG + Zimberelimab for 3 cycles of treatment prior of first radiological and TURB re-evaluation.\n\nPatients with stable disease or downstaging will continue Zimberelimab up to 1 year. The goal of this trial is to demonstate that Sacituzumab Govitecan + Zimberelimab can avoid cistectomy and can prolong or avoid recurrence to metastatic disease in selected patients with muscle-invasive bladder cancer.\n\nThe primary endpoint of this trial is Event Free Survival that is defined as clinical evidence of new or progressing nodal or any distant metastatic disease, radical cystectomy, or death due to any cause from date of inclusion to the first documentation of a EFS event.",[62,26,270,271],"Bladder Neoplasm","Muscle-Invasive Bladder Carcinoma",[167,273,274],"muscle-invasive bladder cancer","bladder sparing","2024-07-25",{"date":277,"type":39},"2024-07-30",{"date":279,"type":20},"2024-12-02",{"date":281,"type":20},"2029-12-31",{"name":283,"class":46},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":293,"conditions":294,"keywords":303,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":77},"100528944","study-on-the-occurrence-of-possible-relapses-and-on-the-quality-of-life-in-patients-who-underwent-turbk-100528944","NCT06167356","Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent TURBK.","Observational Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent Endoscopic Resection Surgery for Bladder Cancer (TURBK).","Inclusion Criteria:\n\n* 18 years or older\n* Patients with non-muscle invasive bladder cancer\n* Indication to cancer removal through endoscopic resection surgery\n* Ability to read and sign the informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Inability to read and sign the informed consent",{"count":292,"type":20},20000,"A database has been created and will be used in which data will be collected in electronic format relating to adult patients who underwent one of the following endoscopic resection surgeries: TURBK, MAPPING, TURBK SECOND LOOK, BLADDER BIOPSIES.",[295,296,297,62,298,270,26,299,300,301,302],"Non Muscle Invasive Bladder Cancer","Non-Muscle Invasive Bladder Neoplasms","Non-Muscle Invasive Bladder Urothelial Carcinoma","Bladder Disease","Bladder Cancer Stage I, With Cancer in Situ","Bladder Cancer Recurrent","Bladder Urothelial Carcinoma in Situ","Bladder Urothelial Dysplasia",[304,26,270,298,62,305],"Intravescical Therapies","Intravesical Instillations","2023-12-11",{"date":308,"type":39},"2023-12-12",{"date":310,"type":39},"2013-11-27",{"date":312,"type":20},"2063-11-27",{"name":314,"class":46},"IRCCS San Raffaele",{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":324,"conditions":325,"keywords":340,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":77},"100529161","study-on-the-quality-of-life-and-pathological-state-in-patients-who-underwent-radical-cystectomy-100529161","NCT06170177","Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy","Bladder Archive: Observational Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy","Inclusion Criteria:\n\n* subjects underwent radical cystectomy\n* \\> 18 years old\n* Ability to read and sign the informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Inability to read and sign the informed consent",{"count":323,"type":20},4000,"Observational study on the quality of life and pathological state of patients underwent radical cystectomy.",[271,326,327,328,329,330,331,62,332,333,334,335,26,336,337,338,339],"Muscle Invasive Bladder Urothelial Carcinoma","Bladder Cancer TNM Staging","Bladder Cancer Stage IIa","Bladder Cancer Stage IIb","Bladder Cancer Stage IV","Bladder Leiomyosarcoma","Bladder Cancer Stage II","Bladder Cancer Stage IIIa","Bladder Cancer Stage IIIb","Bladder Cancer Stage IIIc","Progression, Disease","Urinary Diversion","Neobladder","Radical Cystectomy",[339],"2023-12-06",{"date":343,"type":39},"2023-12-14",{"date":345,"type":39},"2013-02-04",{"date":347,"type":20},"2063-02",{"name":314,"class":46}]