[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-muscle-invasive-bladder-cancer-nmibc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-muscle-invasive-bladder-cancer-nmibc":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,40,64,92,116,139,176,196,245,277,302,328,348,369,391,417],{"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":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100652739","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-rag-01-as-monotherapy-and-in-combination-with-chemotherapy-in-patients-with-non-muscle-invasive-bladder-cancer-nmibc-100652739",false,"NCT07777848","A Study to Evaluate the Efficacy and Safety of RAG-01 as Monotherapy and in Combination With Chemotherapy in Patients With Non-muscle Invasive Bladder Cancer (NMIBC).","A Randomized, Controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of RAG-01 Monotherapy and RAG-01 in Combination With Chemotherapy in Intermediate\u002FHigh-risk Patients With Non-muscle Invasive Bladder Cancer (NMIBC).","Inclusion Criteria:\n\n1. Voluntarily agrees to participate in this study and provides written informed consent prior to the initiation of any study-specific procedures.\n2. Is aged ≥18 years at the time of signing the informed consent form (ICF).\n3. Has histologically confirmed tumor tissue obtained within 12 weeks prior to the first study treatment, with urothelial carcinoma as the predominant histologic subtype (≥90%), and is classified according to the American Urological Association (AUA) guidelines as follows:\n\n   * Cohort A: high-risk non-muscle-invasive bladder cancer (NMIBC).\n   * Cohort B: intermediate-risk NMIBC.\n4. Regardless of prior bacillus Calmette-Guérin (BCG) treatment, is confirmed before enrollment to be BCG-intolerant, ineligible for BCG, unwilling to receive BCG, or unable to access BCG treatment for any reason.\n5. Has no resectable lesion, as confirmed by cystoscopy and\u002For transurethral resection of bladder tumor (TURBT), within 12 weeks prior to the first administration of study treatment.\n6. Is willing to provide pathological tissue specimens.\n7. Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.\n8. Has adequate hematologic and organ function within 14 days prior to enrollment.\n9. Female participants must agree to use effective contraception during treatment or be surgically sterile or postmenopausal. Women of childbearing potential must have a negative pregnancy test during the screening period; however, pregnancy testing is also required for participants with bilateral tubal ligation. Male participants must be surgically sterile or agree to use effective contraception during treatment. Participants must use contraception from the time of signing the ICF until 3 months after completion of study treatment. The definition of effective contraception will be based on the investigator's judgment.\n\nExclusion Criteria:\n\n1. Low-risk NMIBC.\n2. Very high-risk NMIBC.\n3. Tumors staged as T2 or higher, or urothelial carcinoma of the upper urinary tract or urethra (renal pelvis, ureter, or urethra).\n4. Predominantly non-urothelial histology, including squamous cell carcinoma, adenocarcinoma, or other non-urothelial carcinomas.\n5. Receipt of antitumor intravesical therapy between the most recent transurethral resection of bladder tumor (TURBT) and the first administration of study treatment, except for a single immediate postoperative intravesical chemotherapy instillation.\n6. Receipt of any antitumor therapy within 4 weeks prior to the first administration of study treatment.\n7. Participation in another clinical trial involving an antitumor investigational drug within 4 weeks prior to the first administration of study treatment.\n8. Prior treatment with small nucleic acid-based antitumor agents, p21-targeted antitumor agents, or cyclin-dependent kinase (CDK) inhibitors.\n9. Major surgery within 4 weeks prior to signing the informed consent form (ICF).\n10. History of malignancy within 2 years prior to enrollment, except for curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; or ongoing requirement for antitumor therapy.\n11. Any Grade ≥3 hemorrhage, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0, at any site within 6 weeks prior to enrollment, regardless of whether the event has resolved.\n12. Chronic renal injury or inflammation, or renal injury or inflammation not recovered to Grade ≤1 according to NCI CTCAE version 6.0.\n13. Any of the following within 6 months prior to enrollment: myocardial infarction; severe or unstable angina; coronary or peripheral arterial bypass grafting; symptomatic congestive heart failure; cerebrovascular accident or transient ischemic attack; or pulmonary embolism.\n14. Uncontrolled hypertension.\n15. New York Heart Association (NYHA) Class III or IV heart failure, or left ventricular ejection fraction (LVEF) \\\u003C50%.\n16. Prolonged corrected QT (QTc) interval.\n17. Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or tuberculosis at screening, including HIV antibody positivity; hepatitis B surface antigen (HBsAg) positivity with detectable HBV DNA; or HCV antibody positivity with detectable HCV RNA.\n18. Severe infection within 4 weeks prior to the first administration of study treatment, or active infection of Grade ≥2 per CTCAE requiring systemic antibiotic treatment within 1 week prior to the first administration of study treatment.\n19. Intolerance of or inability to receive intravesical instillation, or inability to retain intravesical study treatment for the duration required by the protocol for any reason.\n20. Anuria, urinary incontinence, or urinary tract obstruction within 4 weeks prior to enrollment.\n21. Persistent gross hematuria despite treatment within 1 week prior to enrollment.\n22. Uncontrolled pleural effusion, pericardial effusion, or ascites.\n23. Severe pulmonary disease of significant clinical relevance.\n24. Confirmed vesicoureteral reflux or bladder perforation.\n25. Any other serious acute or chronic medical condition that, in the investigator's judgment, may increase the risk associated with study participation or study treatment, or may interfere with the interpretation or assessment of study results.\n26. Severe psychological or psychiatric disorder that, in the investigator's judgment, is likely to result in inadequate compliance with study requirements.","ALL","18 Years",{"count":19,"type":20},114,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a randomized, controlled, multicenter clinical study to evaluate the efficacy and safety of RAG-01 monotherapy and in combination with chemotherapy in patients with NMIBC.",[26],"Non-muscle Invasive Bladder Cancer (NMIBC)","NOT_YET_RECRUITING","2026-08-17",{"date":30,"type":31},"2026-08-20","ACTUAL",{"date":33,"type":20},"2026-09",{"date":35,"type":20},"2029-03",{"name":37,"class":38},"Ractigen Therapeutics.","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100651247","a-prospective-study-evaluating-the-safety-and-performance-of-the-eight-medical-hyperthermia-system-iv-10-for-hivec-in-nmibc-100651247","NCT07758881","Evaluating the Safety and Performance of the Eight Medical Hyperthermia System IV 1.0 for HIVEC in NMIBC.","A Prospective, Single-arm, Interventional Study to Evaluate the Safety and Performance of the EIght Medical hyPeRthermia System IV 1.0, Used to Deliver Recirculating Hyperthermic Intravesical Chemotherapy (HIVEC) With Mitomycin C (MMC) for Treatment of Adult Patients With nOn-Muscle inVasive bladdER Cancer (NMIBC)","Inclusion Criteria:\n\n1. ≥ 18 years of age at study entry.\n2. Histologically confirmed intermediate-risk or high-risk NMIBC, as defined by the 2025 version of the European Association of Urology (EAU) guidelines.\n3. ECOG Performance Status of 0-2.\n4. Candidate for HIVEC according to clinical judgment and the device and medicinal product labeling\u002Fcontra-indications.\n5. The participant and investigator signed and dated the informed consent form prior to the treatment.\n6. Available, willing, and with sufficient cognitive awareness to comply with the protocol or proposed follow-up visits.\n\nExclusion Criteria:\n\n1. A small bladder capacity (\\\u003C150 ml), based on site standard assessment and investigator judgment.\n2. Active or uncontrolled Urinary Tract Infection (UTI), defined as clinical signs\u002Fsymptoms and\u002For microbiological evidence requiring treatment per investigator judgment.\n3. Positive urine culture prior to the instillation that indicates active infection not adequately treated or controlled.\n4. Inability to hold urine for more than 1 hour.\n5. Gross hematuria that precludes safe catheterization or intravesical therapy.\n6. Severe bladder wall damage or other bladder pathology that increases the risk of complications or prevents safe instillation.\n7. Non-controlled bladder overactivity that prevents completion of the planned dwell time.\n8. Urethral strictures or other anatomical\u002Ffunctional conditions that complicate or prevent safe catheterization.\n9. Known vesico-ureteral reflux that increases risk with intravesical chemotherapy.\n10. Inability to remain in the supine position for at least 60 minutes.\n11. Known allergy or hypersensitivity to Mitomycin C.\n12. Current or history of clinically significant hematologic disorder that may increase risk of bleeding, infection, or systemic toxicity, or confound safety assessment.\n13. Autoimmune disease, systemic inflammatory disease or other medical conditions that will likely affect study outcomes or participant safety.\n14. Tumor tissue in the bladder containing \\\u003C50% urothelial cancer.\n15. (A history of) muscle-invasive bladder cancer (≥ T2) or metastatic disease.\n16. Participants with a history of other active malignancies are excluded, except in cases where the malignancy is considered adequately treated, clinically stable, and unlikely to interfere with the safety or efficacy evaluation of the investigational treatment.\n17. Prior HIVEC or intravesical chemotherapy is permitted, provided a minimum washout period of 6 months has elapsed since the last instillation and there are no ongoing clinically significant adverse events from prior treatments.\n18. Participants with concurrent chemotherapy.\n19. Participant is pregnant, plans to become pregnant, or is lactating.\n20. Male participants who are not vasectomized, and are unwilling or unable to use a highly effective method of contraception.\n21. Participant is enrolled in another study or there is concurrent participation or participation within 30 days in any other clinical trial with an investigational product.",{"count":48,"type":20},30,[50],"NA","The goal of this clinical trial is to evaluate the safety and performance of the Eight Medical Hyperthermia System IV 1.0 when used to deliver recirculating hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC) in adult patients with non-muscle invasive bladder cancer (NMIBC).\n\nThe main questions it aims to answer are:\n\n* Is the Eight Medical Hyperthermia System IV 1.0 safe when used to deliver HIVEC with MMC in adult patients with NMIBC?\n* Does the Eight Medical Hyperthermia System IV 1.0 perform as intended by successfully delivering HIVEC with MMC?\n\nParticipants will:\n\n* Receive HIVEC treatment with MMC using the Eight Medical Hyperthermia System IV 1.0 according to the study treatment schedule.\n* Attend scheduled study visits for safety assessments, clinical evaluations, and follow-up.",[26],"2026-08-12",{"date":55,"type":31},"2026-08-14",{"date":57,"type":20},"2027-01",{"date":59,"type":20},"2028-06",{"name":61,"class":62},"Eight Medical International BV","INDUSTRY",2,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100650602","active-surveillance-versus-adjuvant-intravesical-chemotherapy-in-liquid-biopsy-defined-low-shedding-intermediate-risk-nmibc-100650602","NCT07749924","Active Surveillance Versus Adjuvant Intravesical Chemotherapy in Liquid Biopsy-Defined Low-Shedding Intermediate-Risk NMIBC","A Prospective, Multicenter, Randomized, Open-Label, Non-Inferiority Trial of Active Surveillance Versus Adjuvant Intravesical Chemotherapy After Complete Transurethral Resection in Patients With Preoperative Liquid Biopsy-Negative, Intermediate-Risk Non-Muscle-Invasive Bladder Cancer","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically confirmed urothelial carcinoma of the urinary bladder, including tumors with divergent differentiation, provided that the urothelial carcinoma component accounts for \\>50% of the tumor\n3. Non-muscle-invasive bladder cancer classified as intermediate-risk according to the 2021 European Association of Urology (EAU) NMIBC prognostic risk-group definition. Intermediate-risk disease is defined as NMIBC without concomitant carcinoma in situ that does not meet the criteria for the EAU low-, high-, or very-high-risk groups.\n4. Complete transurethral resection of all visible bladder tumors performed within 6 weeks before randomization, with no macroscopically visible residual disease.\n5. Negative multi-urinary liquid biopsy results after complete TURBT and before randomization.\n6. Eastern Cooperative Oncology Group performance status of 0-2.\n7. Adequate clinical condition to undergo protocol-specified intravesical therapy, cystoscopic surveillance, and study-related procedures.\n8. Ability to understand the study requirements and provide written informed consent.\n\nExclusion Criteria:\n\n1. EAU low-risk, high-risk, or very-high-risk NMIBC.\n2. Any current or previous concomitant carcinoma in situ associated with the qualifying tumor episode.\n3. Muscle-invasive bladder cancer, locally advanced urothelial carcinoma, lymph-node involvement, or metastatic urothelial carcinoma.\n\n   Incomplete TURBT, macroscopically visible residual tumor, or inability to achieve complete endoscopic resection before randomization.\n4. Urothelial carcinoma involving the prostatic stroma or prostatic ducts, or carcinoma in situ of the prostatic urethra.\n5. Severe lower urinary tract dysfunction, bladder capacity considered insufficient for intravesical treatment, or another clinically significant urological condition that may interfere with treatment or outcome assessment.\n6. Another active malignancy requiring systemic treatment or likely to interfere with the assessment of study endpoints, except adequately treated non-melanoma skin cancer, localized prostate cancer under surveillance, or another malignancy with a negligible risk of recurrence, as determined by the investigator.\n7. Pregnant or breastfeeding women.\n8. Any serious uncontrolled medical, psychiatric, or social condition that, in the investigator's judgment, would compromise participant safety, protocol adherence, or interpretation of study results.",{"count":72,"type":20},670,[50],"This study will evaluate whether adjuvant intravesical chemotherapy can be safely omitted under active surveillance after complete transurethral resection in selected patients with EAU intermediate-risk non-muscle-invasive bladder cancer.\n\nPatients with intermediate-risk non-muscle-invasive bladder cancer are commonly treated with transurethral resection followed by adjuvant intravesical chemotherapy to reduce the risk of recurrence. However, not all patients may derive the same benefit from additional intravesical treatment. Some tumors may have a low-shedding phenotype, meaning that they show no detectable tumor-associated signals in urine despite the presence of visible bladder tumors.\n\nIn this study, preoperative urine-based liquid biopsy will be used to identify patients with a low-shedding profile. This profile is defined by negative results across urine cytology, NMP22, urinary DNA methylation, and urinary tumor DNA testing before transurethral resection.\n\nEligible patients with EAU intermediate-risk non-muscle-invasive bladder cancer, a negative preoperative urine-based liquid biopsy profile, and complete tumor resection will be randomly assigned to active surveillance or standard adjuvant intravesical chemotherapy. The study will compare recurrence-free survival between the two groups and assess whether active surveillance can avoid immediate intravesical chemotherapy without compromising oncologic safety. Secondary outcomes will include high-grade recurrence, disease progression, need for subsequent bladder cancer treatment, safety, patient-reported outcomes.",[76,77],"Bladder Cancer","Non-Muscle-Invasive Bladder Cancer (NMIBC)",[79,80,81],"Non-muscle-invasive bladder cancer (NMIBC)","Active surveillance","Liquid biopsy","2026-08-02",{"date":84,"type":31},"2026-08-06",{"date":86,"type":20},"2026-08-10",{"date":88,"type":20},"2032-03-01",{"name":90,"class":38},"Tianjin Medical University Second Hospital",5,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100610249","comparison-of-intravesical-therapy-and-surgery-as-treatment-options-for-bladder-cancer-2-100610249","NCT07225127","Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2","CISTO2","Inclusion Criteria:\n\n1. Adult 18 years of age or older; and\n2. Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with:\n\n   1. Pathology documentation from any hospital\u002Fclinic\u002Fmedical center\n   2. More than 50% urothelial carcinoma component in the specimen; and\n3. History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1; and\n4. In the previous 12 months, received at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment.\n\nExclusion Criteria:\n\n1. Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation);\n2. Previous history of cystectomy or radiation therapy for bladder cancer;\n3. Previous history of muscle-invasive bladder cancer or metastatic bladder cancer;\n4. Untreated or current urinary tract urothelial carcinoma outside of the bladder (e.g. ureters, renal pelvis, penile urethra for males, urethra for females). Urinary tract cancer outside of the bladder treated more than 2 years ago is not an exclusion;\n5. Incarcerated in a detention facility or in police custody at baseline\u002Fscreening (patients wearing a monitoring device can be enrolled);\n6. Contraindication to radical cystectomy (e.g., ASA of 4, patient not considered a radical cystectomy candidate due to comorbidity);\n7. Contraindication to BST (i.e., intolerant of all intravesical and intravenous medical therapies);\n8. Unable to provide written informed consent in English;\n9. Unable to be contacted for research surveys;\n10. Planning to participate in a blinded interventional clinical trial for NMIBC such that details about treatment or therapy received will be unavailable for data collection.",{"count":100,"type":20},408,"OBSERVATIONAL","Bladder cancer is the most common urinary tract cancer and the 6th most common cancer in the US. Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer Study 2 (CISTO2) has the potential to fill these critical evidence gaps, change care pathways for the management of NMIBC (non-muscle-invasive bladder cancer), and provide for personalized, patient-centered care. The purpose of CISTO2 is to conduct a large prospective study that directly compares the impact of bladder sparing therapies versus bladder removal in recurrent high-grade NMIBC patients on financial toxicity, clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).",[76,104,26],"Recurrent Bladder Cancer","RECRUITING","2026-07-29",{"date":108,"type":31},"2026-07-31",{"date":110,"type":31},"2025-11-03",{"date":112,"type":20},"2028-12",{"name":114,"class":38},"University of Washington",6,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":21,"phases":126,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":137,"locationsCount":39},"100649007","lcs103-herbal-formula-for-secondary-prevention-of-non-muscle-invasive-urothelial-carcinoma-of-the-bladder-100649007","NCT07728474","LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder","LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder - Phase IIA Randomized Controlled Trial","LCS103","Inclusion Criteria:\n\n* Men and women aged ≥ 18 years.\n* Non-muscle invasive urothelial carcinoma, histologically confirmed by TURBT procedure within 3 months before enrollment.\n* Complete resection of bladder tumor in recent TURBT.\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Inability to swallow tablets (esophageal stricture, feeding through gastrostomy).\n* Ineligibility for SOC therapy such as BCG instillations (where appropriate).\n* Upper tract urothelial carcinoma within the past 2 years.\n* Any malignancy other than NMIBC, active or systemically treated within the past 2 years (not including localized cutaneous basal cell or squamous cell carcinoma).\n* Estimated life expectancy \\\u003C 5 years.\n* Pregnant women, and women planning future pregnancy or wishing to preserve fertility.\n* Investigator evaluation of a physical or mental condition limiting a patient's ability to participate in the study.",{"count":125,"type":20},60,[50],"This study is a phase IIA, single-site, randomized, controlled, open-label clinical trial evaluating the safety and efficacy of the LCS103 oral herbal formula for the secondary prevention of NMIBC. The study will include 60 participants randomized 1:1 to either the investigational or control arm.\n\nPatients in the investigational arm will receive three oral tablets of LCS103 herbal formula twice daily for 1 year, in addition to the SOC recommended per risk group:\n\n* Low Risk: Cystoscopic follow-up at 3 \\& 9 months and yearly thereafter.\n* Intermediate Risk: 1-year intravesical instillations of BCG. Cystoscopic follow-up at 3 \\& 9 months, then biannually for 2 years and yearly thereafter.\n* High Risk: 3-year intravesical instillations of BCG. Cystoscopy and urine cytology every 3 months for 2 years, then biannually thereafter.\n\nParticipants in the control arm will receive SOC treatment as mentioned above. After 1 year, the investigational treatment will be stopped, and all participants will continue SOC treatment and surveillance.\n\nThe enrollment period is expected to be 1 year. The study will be terminated after the final visit of the last patient. The total study duration is expected to be 2 years.",[26],[130,76,131],"NMIBC","Non-Muscle Invasive Bladder Cancer","2026-07-28",{"date":106,"type":31},{"date":135,"type":20},"2026-07",{"date":112,"type":20},{"name":138,"class":62},"LifeBiotic Medical Research Ltd.",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":147,"briefSummary":149,"conditions":150,"keywords":157,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":175},"100648779","phase-1-a-phase-1-dose-escalation-study-of-ugn-501-administered-intravesically-in-adult-participants-with-recurrent-nmibc-100648779","NCT07725796","A Phase 1 Dose-escalation Study of UGN-501 Administered Intravesically in Adult Participants With Recurrent NMIBC","A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UGN-501 Administered Intravesically in Adult Participants With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)","Inclusion Criteria:\n\n1. Participant must be 18 years of age or older at the time of signing informed consent.\n2. Has confirmed recurrent non-muscle invasive bladder cancer (NMIBC) with high-grade Ta and\u002For T1 disease and\u002For carcinoma in situ (CIS), or recurrent low-grade Ta and\u002For T1 disease.\n3. Participants with high-grade Ta and\u002For T1 disease and\u002For CIS must meet one of the following criteria:\n\n   * Has BCG-unresponsive disease, defined as:\n   * persistent or recurrent CIS alone or with recurrent Ta\u002FT1 disease within 12 months of completion of adequate BCG therapy; or\n   * recurrent high-grade Ta\u002FT1 disease within 6 months of completion of adequate BCG therapy; or\n   * high-grade T1 disease at the first evaluation following a BCG induction course.\n\n   Adequate BCG therapy is defined as at least 5 of 6 doses of an initial induction course plus either at least 2 of 3 doses of maintenance therapy or at least 2 of 6 doses of a second induction course. Participants with BCG-unresponsive disease also must be unwilling or unfit to undergo radical cystectomy.\n   * Is BCG-exposed, defined as high-grade persistent or recurrent NMIBC within 24 months of the last dose of BCG but not meeting the definition of BCG-unresponsive disease, and received at least 5 of 6 doses of an initial induction course of BCG.\n   * Is BCG intolerant, defined as the inability to tolerate at least 1 full induction course of BCG.\n   * Has a high-grade Ta tumor ≤3 cm and failed at least 1 previous course of therapy, such as TURBT plus an adjuvant induction course of intravesical chemotherapy.\n4. Participants with low-grade disease must meet one of the following criteria:\n\n   * Ta tumors recurring within 1 year.\n   * Ta solitary tumor \\>3 cm.\n   * Ta multifocal tumors.\n   * T1 tumors.\n5. All visible papillary tumors must be resected and obvious areas of CIS fulgurated during Screening or within 6 weeks before Screening. Participants with T1 disease should have a re-staging TURBT during Screening or within 6 weeks before Screening. Enhanced cystoscopy, such as blue light cystoscopy or other locally accepted modalities, is permitted, but the same modality must be used for all subsequent disease assessments.\n6. Has Eastern Cooperative Oncology Group performance status score ≤2.\n7. Has no concomitant upper tract urothelial carcinoma (UTUC) or urothelial carcinoma within the prostatic stroma. Freedom from upper tract disease, if clinically indicated, must be demonstrated by no evidence of upper tract tumor by either IV pyelogram, retrograde pyelogram, CT urogram with or without contrast, MRI urogram with or without contrast, or ureteroscopy with ureteral washing for cytology, performed within 6 months of enrollment. Participants with urothelial carcinoma involving the prostatic urethra, where carcinoma is confined to the ducts and\u002For epithelium, may be included after a restaging TURBT is performed to rule out more extensive disease involving the prostatic stroma.\n8. Participants with prostate cancer may be eligible if, after surgery or radiation, they do not meet criteria for biochemical recurrence, or if they are on active surveillance at very low, low, or favorable risk for progression, defined as Gleason Grade Group 1 or 2, Gleason score ≤7, prostate-specific antigen \\\u003C20 ng\u002FdL, and cT1-cT2b, at the discretion of the investigator.\n9. Has adequate organ and bone marrow function within 14 days of treatment initiation, as determined by routine laboratory tests:\n\n   * Leukocytes ≥3000\u002FμL.\n   * Absolute neutrophil count ≥1500\u002FμL.\n   * Platelets ≥100,000\u002FμL.\n   * Hemoglobin ≥9.0 g\u002FdL.\n   * Total bilirubin ≤1.5 × upper limit of normal (ULN).\n   * Aspartate aminotransferase (AST) ≤2.5 × UL\n   * Alanine aminotrasferase (ALT) ≤2.5 × ULN.\n   * Alkaline phosphatase ≤2.5 × ULN.\n   * Estimated creatinine clearance ≥30 mL\u002Fmin using the Cockcroft-Gault equation.\n10. Has a life expectancy \\>12 months.\n11. Participants and participant partners must agree to follow contraception and barrier method requirements consistent with local regulations and the protocol during the study intervention period and for at least 12 weeks after the last study intervention instillation.\n12. Has signed informed consent and is willing and able to comply with the requirements and restrictions listed in the informed consent form and protocol.\n\nExclusion Criteria:\n\n1. Current or previous evidence of muscle invasive, locally advanced nonresectable, or metastatic urothelial carcinoma, including T2, T3, T4, and\u002For stage IV disease.\n2. Current systemic therapy for bladder cancer.\n3. Prior treatment with any human adenovirus-based therapy, such as nadofaragene firadenovec-vncg or cretostimogene grenadenorepvec.\n4. Intravesical therapy within 4 weeks before starting study intervention, including but not limited to BCG, chemotherapy, and nogapendekin alfa inbakicept.\n5. Participation in a study of an investigational agent with receipt of study therapy, or receipt of an investigational device, within 4 weeks before the first dose of study intervention.\n6. Receipt of immune modulator therapy within 5 half-lives of starting study intervention, including but not limited to pembrolizumab, BCG, and nogapendekin alfa inbakicept.\n7. Receipt of a vaccine or anti-viral agent within 2 weeks before starting study intervention.\n8. Active infection requiring systemic therapy, including urinary tract infection. Participants may enter the study once the infection is satisfactorily treated.\n9. Immunocompromised state, including but not limited to HIV infection or any condition that required systemic immunosuppressive treatment in the past 2 years, such as active systemic autoimmune disease or solid organ or stem cell transplant. Short courses (≤14 days) of steroids for medical reasons without anticancer intent, such as atopic dermatitis, psoriasis, infection, or allergic reaction, are permitted if the last dose was at least 4 weeks before the first dose of study intervention.\n10. Any medical, psychological, familial, sociological, or geographical condition that, in the opinion of the investigator, would preclude participation in the study.\n11. History of malignancy of another organ system within the past 5 years, except previously treated UTUC, basal cell carcinoma or squamous cell carcinoma of the skin, and\u002For prostate cancer meeting protocol-specified criteria.\n12. Cannot tolerate intravesical dosing or intravesical surgical manipulation.\n13. Known allergy or hypersensitivity to any of the study interventions or any study intervention excipients.",{"count":48,"type":20},[148],"PHASE1","This study is being conducted to evaluate the safety and tolerability of UGN-501 administered intravesically in adult participants with recurrent non-muscle invasive bladder cancer (NMIBC) and to determine the recommended Phase 2 dose (RP2D).",[151,130,152,153,154,155,156,26],"Bladder (Urothelial, Transitional Cell) Cancer","Urothelial Carcinoma Bladder","Urothelial Carcinoma in Situ","Urothelial Carcinoma Recurrent","Urothelial Carcinoma of the Urinary Bladder","Non-Muscle Invasive Bladder Carcinoma",[158,159,160,161,162,163,164,165],"CIS","Ta bladder cancer","T1 bladder cancer","BCG-unresponsive NMIBC","BCG-exposed NMIBC","BCG-intolerant NMIBC","Intravesical therapy","Oncolytic Virus","2026-07-21",{"date":168,"type":31},"2026-07-24",{"date":170,"type":20},"2026-09-30",{"date":172,"type":20},"2029-08-02",{"name":174,"class":62},"UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd.",11,{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":39},"100643237","phase-2-disitamab-vedotin-plus-intravesical-mitomycin-c-in-her2-expressing-intermediate--to-high-risk-non-muscle-invasive-bladder-cancer-100643237","NCT07646145","Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer","Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Medium-high Risk Non-Muscle-Invasive Bladder Cancer: A Phase II Clinical Trial","Inclusion Criteria:\n\n* Voluntary participation, signing a written informed consent form;\n* The age on the date of signing the informed consent form should be no less than 18 years old, regardless of gender;\n* The subjects have completed the standard TURBT procedure before signing the informed consent form, and no obvious residual tumor lesions were found in the surgical field;\n* The postoperative pathology clearly diagnosed as non-muscle-invasive bladder cancer, and the main tissue component was more than 50% urothelial carcinoma (transitional cell carcinoma);\n* The subjects were classified into the intermediate-risk or high-risk group according to the risk classification for NMIBC;\n* Tumor tissue samples for TURBT must be provided, along with the required relevant pathological reports. Fresh surgical tissues or pathological slides can be sent for examination as well;\n* The patients were intolerant to BCG or did not accept the BCG infusion treatment plan;\n* Before treatment, HER2 detection was conducted on the resection specimens in the laboratory: The IHC results confirmed HER2 expression (defined as: IHC 1+, 2+ or 3+);\n* Clinical non-metastatic bladder cancer (N0, M0) was determined by abdominal computed tomography (CT).\n\nExclusion Criteria:\n\n* History of muscle-invasive bladder cancer or metastatic bladder cancer before treatment;History of muscle-invasive bladder cancer or metastatic bladder cancer before treatment;\n* Imaging results within 3 months before treatment indicated lymph node or other site\u002Forgan metastasis;\n* Imaging results within 3 months before treatment indicated the presence of other urinary system tumors;\n* Received other systemic anti-cancer treatments within 3 weeks before treatment, including chemotherapy, biological therapy, immunotherapy, targeted therapy, endocrine therapy, and\u002For investigational drug therapy;\n* Received bladder radiotherapy for urothelial carcinoma before treatment;\n* Known to have anaphylaxis or delayed allergic reaction to certain components of vedacitinib or similar drugs;\n* Within the 3 days prior to the first infusion, the following conditions had not yet been alleviated to CTCAE grade 1:Uncontrolled acute or chronic infections, such as pneumonia, biliary tract infections;Hepatitis B and Hepatitis C infections; dyspnea;Acute or chronic kidney injury; nephrotic syndrome; bladder perforation; urinary tract obstruction;\n* NYHA rating of 3 or 4;\n* Symptoms and signs related to cardiovascular diseases: including myocardial infarction, congestive heart failure, arrhythmia, etc.;\n* Known cerebrovascular accidents;\n* History of autoimmune diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, hemolytic anemia, rheumatoid arthritis, etc.);\n* Known positive HIV serology, Hepatitis C infection and\u002For Hepatitis B (HepBsAg or core antibody positive and responding after antiviral treatment for Hepatitis B, except for these patients: these patients are allowed to participate in this study; Note: Patients with negative HepBsAg at screening)",{"count":48,"type":20},[23],"This study aims to evaluate the efficacy and safety of intravenous administration of vedacitinib combined with intravesical instillation of mitomycin in treating patients with high-risk NMIBC with HER2 expression. The goal is to provide a new treatment option for NMIBC patients, reduce the risk of tumor recurrence, decrease the proportion of radical bladder surgery, and improve the quality of life of patients.",[77],"2026-06-09",{"date":189,"type":31},"2026-06-12",{"date":191,"type":31},"2024-04-01",{"date":193,"type":20},"2027-04",{"name":195,"class":38},"Shanxi Province Cancer Hospital",{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":21,"phases":206,"briefSummary":207,"conditions":208,"keywords":219,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":39},"100617718","phase-2-intravesical-gemdoce-for-hr-bcg-unresponsive-nmibc-100617718","NCT07322263","Intravesical GEM\u002FDOCE for HR BCG-Unresponsive NMIBC","Intravesical Gemcitabine and Docetaxel for High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: A Prospective Cohort Study (GEMDOCE-BU)","Inclusion Criteria:\n\nHistologically confirmed diagnosis of urothelial carcinoma of the bladder without synchronous or metachronous upper tract involvement or prostatic urethral involvement. Subjects with negative upper tract imaging within 6 months of the study start and visually normal prostates are potentially eligible. Those with a history of suspicious upper tract cytology or suspicious prostatic urethra visually will require additional upper tract washes and\u002For biopsies to rule out concurrent extravesical disease.\n\nEligible bladder cancer presentations include:\n\n* Carcinoma in situ (CIS), with or without non-muscle-invasive stage Ta or T1 tumors of any grade.\n* High-Grade Papillary tumors (stages Ta and\u002For T1) without CIS.\n* All visible bladder tumors must be completely resected within 8 weeks prior to initiating intravesical Gem\u002FDoce therapy.\n* If more than 8 weeks have passed since diagnosis or resection of index bladder CIS ± non-invasive tumor (pTa or T1 tumors), an office cystoscopy must be performed within 8 weeks of Gem\u002FDoce initiation to confirm no visible tumor regrowth.\n\nBCG-Unresponsive Disease as defined by any of the following FDA-accepted criteria:\n\n* Occurrence of high-grade, stage T1 cancer after at least 5\u002F6 weekly BCG induction treatments.\n* Occurrence of CIS within 12 months, or high-grade papillary disease, stage Ta\u002FT1, within 6 months after an \"adequate\" course of BCG therapy.\n\nAn \"adequate\" course of BCG includes at least 5\u002F6 weekly BCG induction treatments and at least 2\u002F3 weekly BCG maintenance or 2\u002F6 weekly BCG re-induction treatments.\n\n* N.B: Physician may have some flexibility (+\u002F- 1 month) in the use of 6 and 12 months to define BCG-unresponsive NMIBC.\n* N.B: Once a patient has been correctly defined as having BCG-unresponsive disease, they will be considered to always be BCG-unresponsive for the purpose of this study. In other words, there is no restriction as to when the BCG-unresponsive term was assigned.\n\n  * The occurrence of low-grade (LG) Ta disease will not be considered a HG relapse event given its prognosis is much more favorable that HG disease. However, all LG tumor must be completely resected before continuing with Gemcitabine\u002FDocetaxel therapy.\n  * Subjects must be eligible for radical cystectomy and decline this standard of care treatment or not be a surgical candidate for radical cystectomy (as appropriate) based on other comorbidities.\n  * All grossly visible disease in the bladder must be fully resected with pathologic stage and grade assessed at the local study institution. Local pathologists are strongly encouraged to use the current LG and HG AJCC criteria.\n\nNB: For institutions that still use the 3-tiered grading system, Ta Gr1 and Gr 2 will be considered LG while any Ta Gr3 or T1 Gr2 or Gr3 will be considered HG.\n\n* Patients enrolled in other clinical trials must have received their last treatment at least 8 weeks prior to enrollment if the treatment was an intravesical agent. If the treatment included a systemic immune-modulating agent (e.g. anti-PD(L)-1 or anti CTLA4) then at least two dosing intervals must have elapsed untreated before the patient is eligible.\n* Age \\> 18 and must be able to read, understand and sign the local informed consent.\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance Status of 2 or less, including patients who are not surgical candidates due to comorbid conditions.\n* Women of childbearing potential must have a negative pregnancy test at screening.\n* All patients of childbearing potential must be willing to consent to using effective contraception, i.e., IUD, Birth control pills, Depo-Provera, and\u002For condoms while on treatment and for 3 months after their last Gemcitabine\u002FDocetaxel treatment.\n* No intravesical or upper tract topical therapy within 8 weeks of study entry.\n* Must be willing and able to comply with all protocol requirements.\n* Should have a Complete Blood Count (CBC) with differential before the index tumor resection or biopsy (within 30 days) and\u002For within 14 days before starting Gemcitabine\u002FDocetaxel therapy.\n* Must be willing and able to give informed consent and any authorizations required by the local Institutional Review Board (IRB) for participation in this study.\n\nExclusion Criteria:\n\n* History or concurrent Stage T2 or greater urothelial cancer.\n* History or concurrent upper tract or prostatic urethral cancer (no suspicious or positive upper tract cytology and negative upper tract imaging within 6 months of study entry; visually normal or absent prostatic urethra by cystoscopy).\n* History or concurrent variant bladder cancer histology including squamous cell carcinoma, adenocarcinoma, small cell carcinoma, plasmacytoid carcinoma, nested urothelial carcinoma, sarcomatoid carcinoma, squamous, glandular, metastatic carcinoma and others. Select urothelial carcinoma with favorable micropapillary differentiation is permitted (see above).\n* Active other malignancies excluding indolent or well-controlled prostate cancer, basal or squamous cell skin cancers or non-invasive cancer of the cervix are permitted so long as they are not expected to impact 3-year survival outcomes.\n* History of severe hypersensitivity reaction (\\>= grade 3) to Gemcitabine and\u002For Docetaxel.\n* History of severe hypersensitivity reaction (\\>= grade 3) to Polysorbate 80 containing drugs (Docetaxel is formulated with Polysorbate 80)\n* Concurrent treatment with any intravesical or systemic chemotherapeutic agent (8-week washout required).\n* Treatment with a checkpoint inhibitor within 2 treatment cycles of enrollment.\n* Major surgery within 3 months of enrollment.\n* Inadequate organ and bone marrow function as evidenced by:\n\n  1. Hemoglobin ≤8.0 g\u002FdL.\n  2. Absolute neutrophil count ≤1.5 x 109\u002FL.\n  3. Platelet count ≤80 x 109\u002FL.\n  4. AST\u002FSGOT and\u002For ALT\u002FSGPT ≥3.0 x ULN.\n  5. Total bilirubin \\>1.5 x ULN excepting known benign Gilbert's Disease.\n  6. Serum creatinine \\>2.0 x ULN.\n\n  i. If creatinine 1.5 - 2.0 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance \\\u003C30 mL\u002Fmin should be excluded.\n* History of radiation to the pelvis.\n* History of difficult catheterization that in the opinion of the Investigator will prevent safe and\u002For reliable administration of the intravesical agents.\n* History of interstitial cystitis or current inability to hold \\~ 2 ounces of fluid in the bladder for the expected 60-minute retention time (assistive medication and\u002For techniques (gravity reflux; split dosing) are permitted).\n* Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy (3- week documented clearance required).\n* Known human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infection.\n* Recent Covid infection within 30 days of enrollment or currently symptomatic of Covid-related illnesses.\n* Significant cardiovascular risk (e.g., coronary stenting within 8 weeks, myocardial infarction within 6 months).\n* Women who are pregnant or lactating.\n* Participation in any other research protocol involving administration of an investigational agent within 6 weeks of study entry (8-week washout required)\n* Any other major or unstable medical condition that in the Investigator's opinion, could affect patient performance status, ability to receive the intravesical therapy and\u002For life expectancy during the five years of intended study participation.","99 Years",{"count":205,"type":20},174,[23],"The goal of this clinical trial is to learn whether a combination of two chemotherapy drugs, Gemcitabine and Docetaxel, can treat high-grade non-muscle-invasive bladder cancer (HG-NMIBC) in adults whose cancer failed conventional BCG therapy. The drugs are given directly into the bladder (intravesically), one immediately after the other.\n\nThe study will also assess the safety of this treatment.\n\nThe main questions it aims to answer are:\n\nCan this drug combination effectively treat HG-NMIBC that did not respond to BCG and help prevent the cancer from coming back, offering long-term protection? What side effects or medical issues do participants experience during treatment?\n\nResearchers will evaluate this non-surgical approach as a potential alternative to bladder removal surgery (radical cystectomy), with the goal of validating it as a bladder-sparing option in this setting.\n\nParticipants will:\n\n* Go through a screening process, including tumor removal and imaging tests\n* Receive weekly bladder treatments with Gemcitabine followed by Docetaxel for 6 weeks\n* If the cancer responds, continue with similar once monthly treatments (maintenance therapy) for up to 2 years\n* Attend regular check-ups, including bladder exams, urine tests, biopsies, and optional quality-of-life surveys\n* Possibly receive a second 6-week treatment cycle if the cancer returns early\n* Be followed for up to 5 years to monitor long-term outcomes",[76,209,210,211,212,213,214,215,216,217,218],"Non-Muscle Invasive Bladder Cancer (NMIBC)","Urothelial Carcinoma","Carcinoma in Situ (CIS)","High-Grade Papillary Bladder Tumors","BCG-Unresponsive Bladder Cancer","Ta Stage Bladder Cancer","T1 Stage Bladder Cancer","BCG-Refractory Bladder Cancer","High-Risk NMIBC","Micropapillary Variant Urothelial Carcinoma (Favorable Subtype)",[209,210,211,212,213,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235],"Intravesical Chemotherapy","Gemcitabine","Docetaxel","Sequential Gemcitabine and Docetaxel","Bladder-Sparing Therapy","Radical Cystectomy Alternative","Prospective Cohort Study","Recurrence-Free Survival","Progression-Free Survival","Cystectomy-Free Survival","Cancer-Specific Survival","Quality of Life (QoL)","FDA-Defined BCG Unresponsive Criteria","ECOG Performance Status","Multicenter International Trial","Bladder Preservation","2026-04-13",{"date":238,"type":31},"2026-04-17",{"date":240,"type":31},"2026-04-10",{"date":242,"type":20},"2033-01-01",{"name":244,"class":38},"Michael A. O'Donnell",{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":254,"conditions":255,"keywords":259,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":4},"100633665","tumor-budding-and-t1-substaging-in-urothelial-bladder-cancer-100633665","NCT07529639","Tumor Budding and T1 Substaging in Urothelial Bladder Cancer","Assessment of Tumor Budding and T1 Substaging as Histopathological Predictors of Outcome in Urothelial Bladder Carcinoma","Inclusion Criteria:\n\n* Patients with a urinary bladder mass, diagnosed by TUR biopsy as urothelial carcinoma.\n* Patients with full clinical data and complete medical reports.\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":253,"type":20},100,"Bladder cancer is a significant global and local health concern, and predicting how aggressive a patient's tumor will behave is critical for guiding treatment. This observational study aims to evaluate two specific microscopic features of urothelial bladder carcinoma to see if they can reliably predict patient outcomes: the depth of early tumor invasion (T1 substaging) and the presence of small clusters of cancer cells at the tumor's edge (Tumor Budding).\n\nResearchers will retrospectively analyze tissue samples (paraffin blocks) from at least 100 patients who were diagnosed with urothelial bladder carcinoma and underwent transurethral resection (TUR) at the South Egypt Cancer Institute between 2018 and 2024.\n\nThe tissue samples will be analyzed in two main ways:\n\n* Early-stage tumors (pT1 cases): Researchers will carefully measure the exact depth the tumor has invaded the bladder lining using anatomical and micrometric sub-classification systems.\n* More advanced tumors (pT2 cases): Researchers will examine the invasive edge of the tumors under a microscope to count \"tumor buds\" (single cells or small clusters of cells).\n\nBy comparing these detailed microscopic measurements with the patients' historical medical records, the study hopes to determine if T1 substaging and Tumor Budding are strong predictors of disease recurrence, disease progression, and overall patient survival.",[256,257,77,258],"Urothelial Bladder Carcinoma","Bladder Carcinoma","Muscle-Invasive Bladder Cancer (MIBC)",[260,261,262,263,264,265,266,267],"Tumor Budding","T1 Substaging","Histopathology","Disease Progression","Survival Outcomes","Transurethral Resection (TUR)","Epithelial-Mesenchymal Transition (EMT)","Invasion Depth","2026-04-08",{"date":270,"type":31},"2026-04-14",{"date":272,"type":20},"2026-05",{"date":274,"type":20},"2027-06",{"name":276,"class":38},"Assiut University",{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":21,"phases":286,"briefSummary":287,"conditions":288,"keywords":290,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":39},"100619064","supporting-sexual-health-in-bladder-cancer-patients-a-sequential-mixed-methods-intervention-study-100619064","NCT07339761","Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study","SPICE: Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study","SPICE","Inclusion Criteria study 1a:\n\n* The participant has one of the following diagnoses and received initial treatment approximately 12 months ago:\n\n  1. Non-muscle-invasive bladder cancer treated with transurethral resection of the bladder (TUR-B)\n  2. Non-muscle-invasive bladder cancer treated with TUR-B and subsequent intravesical instillation therapy with chemotherapy or immunotherapy\n  3. Muscle-invasive bladder cancer treated with cystectomy (removal of the bladder)\n* The participant has experienced changes and\u002For difficulties in sexual function related to the cancer diagnosis and\u002For its treatment\n* The participant speaks and understands Danish\n* The participant is aged 18 years or older\n* The participant has read and understood the oral and written study information\n* The participant has provided written informed consent\n\nExclusion Criteria study 1a:\n\n* The participant has a history of other cancers located in the pelvic region, including rectal cancer, sarcomas, uterine cancer, cervical cancer, ovarian cancer, prostate cancer, or penile cancer\n* The participant has a history of breast cancer\n\nInclusion Criteria study 1b:\n\n* The participant is diagnosed with Muscle-invasive bladder cancer treated with cystectomy (removal of the bladder)\n* The participant speaks and understands Danish\n* The participant is aged 18 years or older\n* The participant has read and understood the oral and written study information\n* The participant has provided written informed consent\n\nExclusion Criteria study 1b:\n\n* The participant has a history of other cancers located in the pelvic region, including rectal cancer, sarcomas, uterine cancer, cervical cancer, ovarian cancer, prostate cancer, or penile cancer\n* The participant has a history of breast cancer",{"count":48,"type":20},[50],"Despite increasing recognition of sexual dysfunction and sexual distress as important survivorship issues in oncology, research and clinical attention remain uneven across cancer types. This imbalance is particularly evident in bladder cancer, where sexual health has received limited research and clinical attention. However, existing studies demonstrate substantial sexual dysfunction and reduced intimacy among patients following disease and treatment.\n\nThe treatment of bladder cancer is a multimodal and multidisciplinary discipline. Low-risk non-muscle-invasive bladder cancer (NMIBC) is treated by transurethral resection of the bladder (TURB) alone, while recurrent intermediate- and high-risk NMIBC undergo a combination of TURB and adjuvant intravesical instillation therapy. For patients with muscle-invasive bladder cancer (MIBC) and specific high-risk NMIBC cases, the first-line treatment option is radical cystectomy with urinary diversion, with or without neoadjuvant chemotherapy.\n\nThese treatment modalities are known to have a negative impact on sexual function, and studies in both men and women demonstrate profound impairments in sexual function, intimacy, and body image after treatment. Among men, erectile and ejaculatory dysfunction are prevalent for this patient group and frequently associated with diminished sexual satisfaction and body-image concerns. Likewise, women experience loss of sexual desire, orgasmic disorders, dyspareunia, and vaginal dryness following cystectomy.\n\nA targeted literature search further identified no contemporary sexology-focused interventional or feasibility trials specifically in bladder cancer (neither MIBC or NMIBC). Existing evidence on the topic is largely descriptive or addresses non-sexological rehabilitation, demonstrating a evidence gap\\[1\\].\n\nQualitative research has also explored informational and psychosocial needs among bladder cancer patients, revealing limited communication about sexual health and unmet needs for professional support. Such studies provide valuable insight into patient experiences but have not yet translated this knowledge into the development of structured, sexological interventions.\n\nEvidence from other cancer populations demonstrates that counselling and psychoeducational programmes addressing intimacy and sexuality are both feasible and beneficial, suggesting that similar interventions could be adapted for bladder cancer care.\n\nTo develop a relevant and acceptable intervention, it is essential to understand how patients themselves perceive their sexual health challenges, informational needs, and preferences for professional support regarding sexual health.\n\nThis project therefore consists of two sequential sub-studies:\n\n* Study 1a (Development phase): A qualitative, exploratory study to develop a sexological intervention with patient and clinician involvement.\n* Study 1b (Feasibility phase): A one-armed feasibility trial assessing the implementation and acceptability of the intervention among patients with muscle-invasive bladder cancer (MIBC).",[76,77,289],"Muscle-Invasive Bladder Carcinoma",[291,76,292],"Sexual Health","Sexual Rehabilitation","2026-01-05",{"date":295,"type":31},"2026-01-14",{"date":297,"type":31},"2026-01-01",{"date":299,"type":20},"2028-08-31",{"name":301,"class":38},"University of Aarhus",{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":21,"phases":311,"briefSummary":312,"conditions":313,"keywords":314,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":4},"100579863","phase-2-clinical-trial-of-ablation-therapy-in-participants-with-intermediate-risk-non-muscle-invasive-papillary-bladder-cancer-100579863","NCT06829823","Clinical Trial of Ablation Therapy in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer","Phase 2 Clinical Trial of Ablation Therapy With Intravesical N-803 In Combination With BCG or Gemcitabine in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Low-grade (LG) Ta papillary disease as determined by Investigator.\n* History of LG NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT). Note: This refers to a previous episode(s) and not to the current episode for which the participant is being screened. Any presence of variant histology, or LVI should be deemed high-risk.\n* Negative voiding cytology for HG disease within 12 weeks prior to screening.\n* Intermediate-risk disease, defined as having 1 or 2 of the following:\n\n  1. Presence of \\>1 and \\\u003C 5 tumors;\n  2. Solitary tumor \\\u003C 3 cm;\n  3. Early or frequent recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis at the initial screening visit).\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.\n* Voluntary written informed consent and HIPAA authorization and agreement to comply with all protocol-specified procedures and follow-up evaluations.\n\nExclusion Criteria:\n\n* Received BCG treatment for urothelial carcinoma.\n* History of HG bladder cancer (papillary or CIS) in the past 2 years.\n* Clinically significant urethral stricture that would preclude passage of a urethral catheter.\n* Life expectancy \\\u003C 2 years.\n* Any of the following clinical laboratory values at the time of enrollment:\n\n  1. Absolute lymphocyte count (ALC) \\> institutional lower limit of normal (LLN)\n  2. Absolute neutrophil count (ANC) \\\u003C 800\u002FμL\n  3. Platelets \\\u003C 50,000\u002FμL\n  4. Aspartate aminotransferase \\[AST\\] or alanine aminotransferase \\[ALT\\]) \\> 2 × upper limit of normal (ULN).\n  5. Creatinine level \\> 3 × ULN. Note: Each study site should use its institutional LLN\u002FULN to determine eligibility.\n* History of or evidence of muscle-invasive, locally advanced, metastatic and\u002For extravesical bladder cancer (inclusive of the prostatic urethra); or any other cancer within the past 5 years that is progressing or requires active treatment. Exceptions are adequately treated basal cell or squamous cell skin cancer that has undergone potentially curative therapy or in situ cervical cancer; adequately treated stage I or II cancer or stable prostate cancer from which the participant is currently in complete remission, and is under active surveillance or hormone control; or any other cancer that investigator feels is stable with permission of Medical Monitor.\n* Suspicion of active upper tract urothelial malignancy.\n* Currently receiving investigational or commercial anticancer agents or anticancer therapies other than BCG, N-803, and supportive care therapies for active disease.\n* Symptomatic congestive heart failure (CHF), New York Heart Association (NYHA) Class III or IV heart failure, or other clinical signs of severe cardiac dysfunction.\n* Severe\u002Funstable angina pectoris, or myocardial infarction within 6 months prior to study entry.\n* History or evidence of uncontrollable central nervous system \\[CNS\\] disease.\n* Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.\n* Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions.\n* Ongoing chronic systemic steroid therapy required (\\>10 mg oral prednisone daily or equivalent).\n* Women who are pregnant or nursing. Female participants of childbearing potential must have a negative pregnancy test and must adhere to using a medically acceptable method of birth control prior to screening and agree to continue its use during the study and for 7 months after the last dose of study drug, or be surgically sterilized (eg, hysterectomy or tubal ligation). Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Males must agree to use barrier methods of birth control while on study and for 90 days post last dose of study drug.\n* Other illness or condition, including laboratory abnormalities, which in the opinion of the Investigator would exclude the participant from participating in this study. This includes, but is not limited to, serious medical conditions or psychiatric illness likely to interfere with participation in the study.",{"count":310,"type":20},20,[23],"This is an open-label, phase 2, randomized study of intravesical N-803 plus BCG (experimental arm A) and intravesical N-803 plus gemcitabine (experimental arm B) in participants who have intermediate-risk Ta\u002FT1 papillary disease. The primary objective of this study is to evaluate the efficacy of these experimental therapies without the need for surgical intervention by CR rate at month 3 or month 6 (for re-inducted participants).",[26],[315,316,317,221,318],"ResQ132A-NMIBC","Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer","BCG","N-803","2025-10-14",{"date":321,"type":31},"2025-10-16",{"date":323,"type":20},"2025-11",{"date":325,"type":20},"2029-11",{"name":327,"class":62},"ImmunityBio, Inc.",{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":21,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":39},"100607323","using-urine-tumor-dna-to-de-intensify-surveillance-in-non-muscle-invasive-bladder-cancer-100607323","NCT07187063","Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer","Inclusion Criteria:\n\n* AUA high-risk bladder cancer1\n* Received induction BCG or gemcitabine\u002Fdocetaxel\n* Negative initial post-induction therapy assessment (negative cytology and cystoscopy +\u002F- biopsy)\n\nExclusion Criteria:\n\n* High-risk NMIBC within 3 years\n* Prior induction intravesical therapy\n* Variant histology\n* Concurrent upper tract disease",{"count":335,"type":20},56,[50],"The goal of this clinical trial is to use urine tumor DNA (utDNA) as an indicator for non-muscle invasive bladder cancer to identify patients suitable for less frequent cystoscopy surveillance.",[26],"2025-09-18",{"date":341,"type":31},"2025-09-22",{"date":343,"type":31},"2025-01-01",{"date":345,"type":20},"2029-01-01",{"name":347,"class":38},"Lahey Clinic",{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":355,"enrollmentInfo":356,"targetDuration":4,"studyType":21,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":367,"locationsCount":368},"100543133","phase-1-a-study-of-rag-01-in-patients-with-non-muscle-invasive-bladder-cancer-nmibc-who-have-failed-bacillus-calmette-gurin-bcg-therapy-100543133","NCT06351904","A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy","A Phase Ⅰ, Open Label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy","Inclusion Criteria:\n\n1. Ability to understand the study and have signed the informed consent form;\n2. Any adult ≥ 18 years old;\n3. Pathologically confirmed high grade NMIBC defined as grade 2 or grade 3 disease;\n4. Expected survival ≥ 6 months;\n5. ECOG PS ≤2;\n6. Sufficient organ functions, as defined below:\n\n   Investigations Hematology Absolute Neutrophil Count (ANC): ≥ 1.5 x 109\u002FL Hemoglobin: ≥ 90 g\u002FL Platelet: ≥ 100 x 109\u002FL Liver Function Serum bilirubin: ≤ 1.25×ULN or 2.5×ULN（with Gilbert syndrome） AST \\& ALT: ≤ 2.5×ULN Renal Function Creatinine Clearance (Cockcroft-Gault equation): ≥ 30 mL\u002Fmin\n7. Subject must be able to tolerate catheterization;\n8. Female subject of childbearing potential and her spouse must use adopt effective contraception (non-pharmacological contraception required) from signing informed consent to within 6 months after the last instillation;\n\nExclusion Criteria:\n\n1. Subject who is allergy to RAG-01 or similar products;\n2. Except for TURBT, the subject received other anti-tumor treatments, and the last administration date is within ≤ 21 days or 5 half-lifes whichever is shorter from the date of signing ICF;\n3. Subject with imaging examination diagnosed extravesical metastasis, including ureter and urethra;\n4. Subject has other malignancies within the past 3 years, except for adequately treated carcinoma of the cervix, basal or squamous cell carcinomas of the skin, or adenocarcinoma of the prostate that has been surgically treated with a post-treatment PSA that is non-detectable;\n5. The following illnesses have not been relieved to CTCAE 0-1:\n\n   1. Uncontrolled acute and chronic infections, such as pneumonia, biliary tract infection, hepatitis B virus infection and hepatitis C virus infection;\n   2. Dyspnea;\n   3. Acute and chronic kidney injury, and inflammation;\n   4. Urinary incontinence;\n   5. Urinary frequency;\n   6. Urinary tract obstruction (except benign prostatic hypertrophy);\n6. Subject could not hold the urine for at least 90 mins due to any reason;\n7. New York Heart Association (NYHA) 3 or 4 grade;\n8. Coronary heart disease related symptoms have not been relieved to CTCAE 0-1, including: myocardial infarction, unstable angina pectoris, congestive heart failure and arrhythmia;\n9. Subject with QTc \\>470 msec.\n10. Cerebrovascular accidents have not been relieved to CTCAE 0-1;\n11. HIV positive; Active hepatitis B or C. For active HBV, it's defined as HBsAg positive with HBV DNA ≥ ULN, for active HCV, it's defined as HCV antibody positive with HCV RNA ≥ ULN, respectively.\n12. Subject is pregnant or lactating during the treatment period;\n13. History of central nervous system or psychiatric disorders, e.g., epilepsy or dementia;\n14. Other severe systemic diseases which might compromise the subject's compliance to the study, e.g., uncontrolled diabetes, gastrointestinal disorders, and renal diseases;\n15. Any other situations which are judged by the investigator, would exposure the subject to unnecessary risk, therefore he\u002Fshe is not eligible.","75 Years",{"count":357,"type":20},72,[148],"This is an open label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of RAG-01 in patients with NMIBC who have failed BCG therapy.",[77],"2025-09-04",{"date":363,"type":31},"2025-09-11",{"date":365,"type":31},"2024-04-03",{"date":299,"type":20},{"name":37,"class":38},3,{"id":370,"slug":371,"hasResults":11,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":21,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":390},"100602354","phase-1-a-study-of-intravesical-fl115-alone-or-in-combination-with-bcg-in-non-muscle-invasive-bladder-cancer-100602354","NCT07122414","A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer","A Phase I\u002FII, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Intravesical FL115 Alone or in Combination With BCG in Subjects With Non-Muscle Invasive Bladder Cancer, Including Dose Escalation and Cohort Expansion","Inclusion Criteria:\n\n1. Male or female subjects aged 18 years or older.\n2. Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology).\n3. Histologically confirmed presence of BCG-unresponsive CIS (with or without Ta or T1 disease) or histologically confirmed presence of BCG-unresponsive high-grade Ta or T1 disease.\n4. Absence of resectable disease after transurethral resection (TURBT) procedures (residual carcinoma in situ (CIS) acceptable; patients with T1 tumors must undergo repeat resection and biopsy \\[inclusive of muscularis propria\\] if initial biopsy did not include muscularis propria). Patients with high-grade Ta and\u002For T1 disease should have complete resection before study treatment.\n5. Subjects refuse or are judged by the investigator not suitable for radical cystectomy.\n6. ECOG score 0-2.\n7. Expected survival ≥ 2 years (judged by the investigator).\n8. Adequate organ function.\n9. Voluntary written informed consent and agree to comply with all protocol-specified procedures and follow-up evaluations.\n\nExclusion Criteria:\n\n1.Prior Anti-Cancer Treatment History:\n\n1. Have previously received IL-2 or IL-15 agonist therapy, including but not limited to rhIL-15 (NCI), ALT-803 (FL-115), and NKTR-214 (Nektar).\n2. Have previously undergone any of the following NMIBC-related treatments:\n\n   1. Received extensive pelvic radiotherapy (involving \\>30% of bone marrow) within 2 years prior to the first dose.\n   2. Received systemic therapy aimed at treating NMIBC (e.g., radiotherapy, chemotherapy, immunosuppressive therapy) within 4 weeks prior to the first dose.\n   3. Received intravesical instillation aimed at treating NMIBC within 4 weeks prior to the first dose, including intravesical local treatment delivered transurethrally.\n   4. Underwent TURBT or other surgical procedures targeting bladder lesions within 2 weeks prior to the first dose.\n\n   2\\. Prior therapies and recovery from related toxicities：\n\na) Known or suspected allergy to FL115, its excipients, interleukin-based therapies, or fusion proteins (Grade 3-4), or to BCG\u002Fexcipients (for Phase Ib\u002FII).\n\nb) Systemic immunosuppressive therapy within 4 weeks before first dose, except: ≤10 mg\u002Fday prednisone equivalent, local\u002Finhaled\u002Fintranasal steroids, adrenal replacement ≤7.5 mg\u002Fday prednisone, or single-dose prophylaxis for contrast allergy.\n\nc) Prior allogeneic organ or PBSC\u002Fbone marrow transplantation. d) Live virus vaccination within 4 weeks prior to first dose. e) Prior ≥ Grade 3 or treatment-discontinuation irAE due to immunotherapy, except controlled hypothyroidism, type 1 diabetes, or limited skin irAEs.\n\nf) Unresolved AEs from prior anti-tumor therapy that have not returned to baseline or ≤ Grade 1 (per CTCAE v5.0) prior to first dose, except alopecia, ≤ Grade 2 neuropathy, or controlled hypothyroidism. Other ≤ Grade 2 AEs require PI and sponsor medical review.\n\n3.Medical and Surgical History:\n\n1. History or current diagnosis of muscle-invasive (T2-T4), locally advanced (T3\u002FT4, any N), or metastatic bladder cancer.\n2. History or evidence of upper urinary tract (kidney, renal pelvis, ureter) or prostatic urethral tumors.\n3. Known vesicoureteral reflux or evidence of bladder perforation.\n4. Active urinary tract infection.\n5. Discontinuation of prior BCG therapy due to severe adverse events such as sepsis, systemic infection requiring treatment, or urinary incontinence (Phase Ib and II applicable).\n6. Post-TURBT complications that preclude intravesical instillation, per investigator judgment.\n7. Clinically significant polyuria (e.g., 24-hour urine volume \\>4000 mL).\n8. History of other malignancies within 2 years prior to screening that have shown progression or required active treatment.\n9. Active or prior autoimmune disease requiring systemic immunosuppressants or corticosteroids.\n10. History of severe pulmonary toxicity.\n11. History or imaging evidence of active pulmonary TB within 1 year prior to enrollment, or prior TB infection not adequately treated.\n12. Uncontrolled pleural, pericardial, or peritoneal effusion deemed clinically significant by the investigator (e.g., requiring repeated drainage \\>once\u002Fmonth).\n13. History of significant cardiovascular disease.\n14. Major surgery within 4 weeks prior to signing informed consent.\n\n    4.Infectious Disease History\n\na) Severe infections within 4 weeks before first dose. b) Any history of confirmed active HBV, HCV, HIV, or active tuberculosis infection.\n\n5.Other Conditions\n\n1. Pregnant or breastfeeding women.\n2. Known, documented, or suspected substance abuse. Exceptions: Prescribed opioids for pain control or other investigator-approved, medically justified cases (pending sponsor medical lead agreement).\n3. Any other conditions deemed by the investigator to render the subject unsuitable for participation.",{"count":377,"type":20},80,[148,23],"The study is to evaluate the safety and tolerability of intravesical FL115 alone or in combination with BCG in the patients with NMIBC, and to determine the RP2D of FL115 in combination with BCG.\n\nTo evaluate the preliminary efficacy of FL115 alone or in combination with BCG in the treatment of NMIBC.\n\nThe study consists of three parts: FL115 monotherapy dose escalation (Phase Ia), FL115 combined with BCG dose escalation (Phase Ib), and FL115 combined with BCG cohort expansion (Phase II).\n\nEach subject will receive FL115 alone or in combination with intravesical BCG, administered over three treatment periods: induction, enhanced induction\u002Fmaintenance 1, and maintenance 2.",[26],"2025-08-12",{"date":383,"type":31},"2025-08-14",{"date":385,"type":31},"2024-08-16",{"date":387,"type":20},"2028-10-10",{"name":389,"class":62},"Suzhou Forlong Biotechnology Co., Ltd",12,{"id":392,"slug":393,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":355,"enrollmentInfo":398,"targetDuration":4,"studyType":21,"phases":400,"briefSummary":402,"conditions":403,"keywords":404,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":413,"leadSponsor":415,"locationsCount":368},"100569634","phase-3-investigating-the-efficacy-and-safety-of-neoadjuvant-intravesical-instillation-of-mitomycin-c-in-treating-high-risk-nmibc-patients-100569634","NCT06696794","Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C in Treating High-risk NMIBC Patients","Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C Combined with En-bloc Surgery in Treating High-risk Non-muscle-invasive Bladder Cancer (NMIBC) Patients","Inclusion Criteria:\n\n1. Voluntarily sign an informed consent form, understand the study and are willing and able to follow and complete all trial procedures\n2. Gender is not limited, age between 18 to 75 years old (inclusive of boundary values)\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n4. Previously confirmed non-muscle-invasive bladder cancer by imaging and pathology\n5. In accordance with the \"EAU Guidelines (2024 edition)\" high-risk NMIBC patient danger grouping. All T1 HG\u002FG3 and CIS patients except for the extremely high-risk group; Ta LG\u002FG2 or T1G1, non-CIS with three risk factors; Ta HG\u002FG3 or T1 LG, non-CIS with at least two risk factors; T1G2 non-CIS with at least one risk factor. (Risk factors: age \\> 70 years; multiple papillary tumors; tumor diameter \\> 3cm)\n6. Participants are willing to provide the last cystoscopy biopsy specimen or specimens from the previous recurrence surgery (including paraffin blocks, paraffin-embedded sections, etc.)\n7. The interval between previous anti-tumor treatments (chemotherapy, radiotherapy, immunotherapy) and the first administration of this trial is ≥6 weeks\n8. Suitable organ function and hematopoietic function: Neutrophil count (NEUT ≥ 1.5 × 10\\^9\u002FL; White blood cell count (WBC) ≥ 3.0 × 10\\^9\u002FL; Platelet count ≥ 100 × 10\\^9\u002FL; Hemoglobin ≥ 90g\u002FL; Serum creatinine ≤ 1.5 times the upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN; Serum total bilirubin ≤ 1.5 times ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 times ULN (except for patients on anticoagulant therapy)\n9. Male participants must agree to use effective contraceptive measures during the treatment period and for at least 180 days after the last treatment, and must not donate sperm during this period; women of childbearing age must have a negative blood pregnancy test within 72 hours before the first new adjuvant instillation, and must agree to use effective contraceptive measures during the treatment period and for at least 180 days after en-bloc treatment\n\nExclusion Criteria:\n\n1. The primary tumor is upper urinary tract urothelial carcinoma of the renal pelvis and ureter\n2. Patients who have suffered from malignant tumors other than bladder urothelial carcinoma within 5 years before enrollment. However, the following patients are included (eligible for enrollment): ① Patients with locally low-risk prostate cancer (staging ≤T2b, Gleason score ≤7, and PSA ≤ 20ng\u002Fml, with no recurrence after treatment as determined by follow-up PSA levels); ② Patients with low-risk prostate cancer (staging T1\u002FT2a, Gleason score ≤7, and PSA ≤10ng\u002Fml, in the observation phase without treatment; ③ Patients who meet other enrollment criteria but have very low risk of metastasis or death from malignant tumors, and who show no recurrence or metastasis after standard treatment, as confirmed by imaging and disease-specific tumor marker tests, such as fully treated carcinoma in situ of the cervix, basal or squamous cell skin cancer; in situ ductal carcinoma after treatment surgery, etc\n3. Patients with active autoimmune diseases who have required systemic treatment (i.e., long-term use of corticosteroids or immunosuppressive drugs) within the past two years. Replacement therapy (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is excluded\n4. Patients who are expected to have major surgery during the study period or who have undergone major surgery within 4 weeks before dosing and have not fully recovered\n5. Any immune-related toxicity caused by previous cancer treatments has not recovered to ≤Grade 1 (except for Grade 2 endocrine disorders on stable dose steroid replacement therapy), and\u002For any other toxicity related to previous anti-cancer treatments (immune-related toxicity excluded) has not recovered to ≤Grade 2, except for alopecia\n6. Patients who are seropositive for Human Immunodeficiency Virus (HIV) or have a history of HIV infection or other acquired immunodeficiency diseases\n7. Patients who require long-term antiviral medication for hepatitis B or C, where hepatitis B (must meet both HBsAg positivity and HBV DNA ≥2000 IU\u002Fml, excluding drug or other causes of hepatitis), hepatitis C (must meet both anti-HCV antibody positivity and HCV-RNA results greater than the lower limit of detection)\n8. Uncontrolled stable systemic diseases, such as cardiovascular and cerebrovascular diseases, diabetes, etc\n9. History of organ transplantation or stem cell transplantation\n10. Heart failure (patients classified as NYHA Class III-IV according to the New York Heart Association)\n11. Significant pulmonary disease (such as shortness of breath at rest or with mild activity or requiring oxygen for any reason)\n12. Other underlying diseases judged by the investigator before the study that prevent the use of study medication or interfere with disease diagnosis, or have the potential to cause serious complications\n13. Concurrent other serious infections before dosing\n14. Alcohol dependence or a history of drug or substance abuse within the last year\n15. A history of clear neurological or psychiatric disorders, such as epilepsy, dementia, poor compliance, or the presence of peripheral nervous system disorders\n16. Pregnancy or breastfeeding, or expected to be pregnant or give birth during the trial period\n17. Known allergy or intolerance to intravenous mitomycin and corresponding excipients\n18. Patients whom the investigator deems unsuitable for the trial for other reasons",{"count":399,"type":20},180,[401],"PHASE3","The goal of this clinical trial is to learn if neoadjuvant intravesical instillation of mitomycin C combined with en-bloc surgery works to treat high-risk non-muscle-invasive bladder cancer (NMIBC) patients. It will also learn about the safety of neoadjuvant intravesical instillation of mitomycin C. The main questions it aims to answer are:\n\nDoes neoadjuvant intravesical instillation of mitomycin C heighten the 1-year recurrence-free survival (RFS) rate for high-risk non-muscle-invasive bladder cancer (NMIBC) patients? What medical problems do participants have when taking neoadjuvant intravesical instillation of mitomycin C? Researchers will compare neoadjuvant intravesical instillation of mitomycin C to a placebo (normal saline) to see if neoadjuvant intravesical instillation of mitomycin C works to treat high-risk NMIBC.\n\nParticipants will:\n\nTake neoadjuvant intravesical instillation of mitomycin C or a placebo twice，1 day and 4 hours before en-bloc surgery Visit the clinic once every 8 weeks for checkups and tests Keep track of the recurrence and progression of the tumor.",[77],[405,406,407,408],"high-risk non-muscle-invasive bladder cancer","neoadjuvant intravesical instillation","mitomycin C","en-bloc surgery","2025-02-17",{"date":411,"type":31},"2025-02-19",{"date":409,"type":31},{"date":414,"type":20},"2031-06-30",{"name":416,"class":38},"Shaogang Wang",{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":21,"phases":426,"briefSummary":427,"conditions":428,"keywords":429,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":439},"100530410","phase-1-a-study-to-investigate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-sim0237-alone-or-in-combination-with-bcg-in-nmibc-100530410","NCT06186414","A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC","An Open-Label, Multicenter Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in Non-Muscle-Invasive Bladder Cancer","Inclusion Criteria:\n\n* Written informed consent.\n* ≥ 18 years of age, male or female.\n* • Histologically confirmed presence of BCG-unresponsive CIS (with or without Ta or T1 disease) or histologically confirmed presence of BCG-unresponsive high-grade Ta or T1 disease. Histologic confirmation of urothelial carcinoma (mixed histology tumors allowed if urothelial histology is predominant histology).\n* Dose escalation phase: BCG-unresponsive high-risk NMIBC.\n* Dose expansion phase: a) Cohorts 1 and 3: BCG-unresponsive CIS (with or without Ta or T1 disease); b) Cohort 2 and 4: BCG-unresponsive high-risk Ta or T1 disease.\n* Absence of resectable disease after transurethral resection (TURBT) procedures \\[residual carcinoma in situ (CIS) acceptable\\]. patients with T1 tumors must undergo repeat resection and pathological test if initial pathological test sample did not include muscularis propria, to ensure the inclusive of muscularis propria and the absence of invasive tumor.\n* Not suitable for or unwilling to undergo radical cystectomy.\n* ECOG performance status of 0, 1or 2.\n* Life expectancy ≥ 2 years.\n* Adequate hematologic and organ function.\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test. WOCBP and male subjects agree to use adequate contraception.\n* Tumor tissue (archival or fresh) for biomarker analysis.\n\nExclusion Criteria:\n\n* • Subjects received TURBT or other surgical treatment for bladder lesions or pelvic radiotherapy or interventional therapy within 2 weeks prior to the first dose.\n* Previous treatment with: a) IL-15 or IL-2; b) immune checkpoint inhibitors (such as anti-PD-1 or PD-L1 antibodies), ADCs, chemotherapies, oncolytic viruses, BCG or other anti-tumor treatments, unless there is clear evidence of disease persistence\u002Frecurrence\u002Fprogression after the above treatments and beyond 4 weeks prior to the first dose; c) Chinese herbal medicine treatment beyond 2 weeks prior to the first dose is allowed; d) A single immediate instillation of chemotherapy within 4 weeks prior to the first dose is allowed; e) intravesical instillation of mucosal protective agents (e.g., sodium hyaluronate) are allowed.\n* Subject is participating in an investigational drug or investigational device study.\n* Subjects have not recovered from AEs caused by previous anti-tumor treatment.\n* History\u002Fevidence of prior muscle-invasive, locally advanced, metastatic bladder cancer or upper urinary tract (kidney, renal pelvis, ureter) and prostatic urethral tumors; or evidence of Ta\u002FT1\u002FCIS urothelial transitional cell carcinoma outside the bladder (urethra, ureter, renal pelvis) during the screening period.\n* Patients with other malignancies within 5 years before the first dose.\n* Any active infection or urinary tract infection requiring systemic treatment by intravenous infusion within 2 weeks before the first dose.\n* Subjects with clinically significant cardiovascular disease within 6 months before the first dose of study treatment.\n* Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).\n* Active or chronic hepatitis B or hepatitis C infection.\n* Known or suspected active autoimmune diseases.\n* Concurrent use of any other anticancer therapy or chronic use of systemic corticosteroids at immunosuppressive doses (more than 10 mg\u002Fday prednisone or equivalent).\n* History of pneumonitis or interstitial lung disease or severe obstructive pulmonary disease that requires oral or intravenous steroids to help recover.\n* Known to be allergic or intolerant to study drugs, monoclonal antibodies, excipients; or allergic or intolerant to BCG (only for subjects receiving combined BCG therapy)\n* Subjects discontinued prior BCG treatment due to AEs such as toxemia, systemic infection, or urinary incontinence (only for subjects receiving combined BCG therapy).\n* History of allogeneic organ transplantation or graft-versus-host disease.\n* Any live vaccines within 4 weeks before the first dose.\n* Known mental illness or substance abuse that would interfere with trial complies.\n* Subject is pregnant or lactating, or is expected to become pregnant or parent a child during the planned study period.\n* Other conditions that investigators consider inappropriate for inclusion.",{"count":425,"type":20},152,[148],"This is an open-label, multicenter phase 1 study to evaluate the safety, efficacy, and pharmacokinetics (PK) characteristics of SIM0237 alone or in combination with bacillus Calmette-Guerin (BCG) in participants with Non-Muscle-Invasive Bladder Cancer (NMIBC)",[77],[130],"2025-01-13",{"date":432,"type":31},"2025-01-15",{"date":434,"type":31},"2024-01-23",{"date":436,"type":20},"2030-12",{"name":438,"class":62},"Jiangsu Simcere Pharmaceutical Co., Ltd.",14]