[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nmibc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nmibc":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,40,57,95,118,139,168,197,224,254,276,296,316,336],{"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},"100625565","phase-3-a-study-of-intravesical-shr-1501-combination-with-bcg-versus-investigator-selected-chemotherapy-in-subjects-with-bcg-unresponsive-nmibc-100625565",false,"NCT07424287","A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC","A Multicenter, Randomized, Open-label Phase III Clinical Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Investigator-selected Chemotherapy In Patients With BCG-unresponsive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC) (NiBladder 1)","Inclusion Criteria:\n\n1. Aged at least 18 years, gender is not limited;\n2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;\n3. Histologic confirmation of high-risk non-muscle invasive bladder cancer (high-grade Ta and\u002For any T1, no carcinoma in situ); BCG-unresponsive;\n4. Cystoscopy within 6 weeks before the randomization shows that the lesion has been completely removed; for T1 stage lesions, pathological results must show the presence of bladder muscle tissue;\n5. Not suitable for or unwilling to undergo radical cystectomy;\n6. Sufficient hematology and organ function.\n\nExclusion Criteria:\n\n1. Previous histopathological diagnosis was muscle-invasive, locally advanced or metastatic urothelial carcinoma (T2 or T3 or T4 or N+ or M+);\n2. Received surgery such as TURBT or radiotherapy for bladder lesions within 2 weeks before the randomization; Major surgery was performed within 28 days before randomization;\n3. Those who have previously received the following treatments and have not experienced disease recurrence or progression before enrolment: a) Intravesical infusion of cytotoxic chemotherapy or other drugs (such as oncolytic viruses), etc; b) Immune checkpoint inhibitors; c) Other investigatory drugs for the treatment of NMIBC;\n4. Those who have previously received immunostimulant therapy;\n5. Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration;\n6. Previous medical history or examination suggests active tuberculosis within 1 year prior to the randomization.","ALL","18 Years",{"count":19,"type":20},236,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a multicenter, randomized, open-label phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus investigator-selected chemotherapy in patients with BCG-unresponsive papillary-only non-muscle-invasive bladder cancer (NMIBC).",[26],"NMIBC","NOT_YET_RECRUITING","2026-05-29",{"date":30,"type":31},"2026-06-02","ACTUAL",{"date":33,"type":20},"2026-06",{"date":35,"type":20},"2030-06",{"name":37,"class":38},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","INDUSTRY",2,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":46,"enrollmentInfo":4,"targetDuration":4,"studyType":47,"phases":4,"briefSummary":48,"conditions":49,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":54,"locationsCount":56},"100578349","resq132ex-nmibc-expanded-access-use-of-recombinant-bacillus-calmette-gurin-in-nonmuscle-invasive-bladder-cancer-100578349","NCT06810141","ResQ132EX-NMIBC: Expanded Access Use of Recombinant Bacillus Calmette-Guérin in Nonmuscle Invasive Bladder Cancer","Participant Eligibility:\n\nWomen and men of all races and ethnic groups are eligible for this trial.\n\nInclusion Criteria and Contraindications:\n\nParticipants must meet the inclusion criteria and contraindications determined by the standards of their institution per the TICE BCG label. In BCG naïve subjects with NMIBC, enrollment should occur only if TICE BCG is unavailable.","100 Years","EXPANDED_ACCESS","This expanded access protocol is designed to provide Recombinant Mycobacterium BCG (rMBCG) to patients with Non-muscle invasive bladder cancer (NMIBC) who are eligible to receive TICE® BCG, may benefit from its use, and who are ineligible to participate in a clinical trial using rMBCG, or for other reasons cannot participate (eg, geographically unable to access a study site).",[26],"AVAILABLE","2026-05-13",{"date":53,"type":31},"2026-05-14",{"name":55,"class":38},"ImmunityBio, Inc.",66,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":68,"conditions":69,"keywords":75,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100476433","phase-1-a-phase-1-open-label-trial-of-belzupacap-sarotalocan-au-011-in-bladder-cancer-100476433","NCT05483868","A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer","A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) to Determine the Feasibility and Safety of Intratumoral Injection With or Without Intramural Injection in Subjects With Bladder Cancer","Inclusion Criteria:\n\n1. Meet the following histopathologic requirements for urothelial carcinoma:\n\n   * For Cohorts 1b, 4a-c:\n\n   histopathological diagnosis of NMIBC (any grade) is required. For participants with first diagnosis of NMIBC, confirmation of urothelial carcinoma by recent biopsy (≤6 months of Screening Visit) is required. Participants with recurrent NMIBC must have a current lesion that clinically appears to be NMIBC with histopathologic confirmation based on TURBT or biopsy within the last 24 months).\n\n   For Cohorts 4d, 4e, 4g and 4h, a diagnosis of LG IR NMIBC (according to\n\n   AUA risk classification guidelines) is required, specifically:\n   * Multifocal LG Ta; OR\n   * Solitary LG Ta \\>3 cm; OR\n   * Low-grade Ta with prior recurrence(s) within 1 year.\n\n   For Cohorts 4f and 4i, a diagnosis of HR NMIBC (according to AUA risk classification guidelines) is required, specifically:\n   * Ta HG papillary disease with or without CIS; OR\n   * T1 papillary disease with or without CIS\n   * Participants may be BCG-naïve or may have received prior treatment with BCG for HR or IR NMIBC (BCG-exposed, BCG-failed, BCG-intolerant)\n   * BCG-refractory participants are excluded. BCG-refractory is defined by the following:\n\n     * Persistent HG disease at 6 months following adequate BCG (defined as ≥5\u002F6 induction instillations and ≥2 additional doses, either from re-induction or maintenance), OR\n     * HG T1 disease at first evaluation (3 months) after BCG, OR\n     * Persistent CIS that remains despite a second BCG course, OR\n     * Disease progression in stage or grade during BCG therapy, including maintenance\n2. Have no evidence of current or prior metastatic urothelial carcinoma\n3. Adequate bone marrow, renal, and hepatic function\n\nExclusion Criteria:\n\n1. Any additional malignancy that requires active treatment, unless deemed appropriate after discussion by the Investigator with the trial's Medical Monitor.\n2. Used an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) of Visit 1 or be concurrently enrolled in another investigational trial.\n3. Active bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy and subject must be off all systemic anti-infective agents.\n4. Active autoimmune disease, chronic inflammatory condition, or other conditions (like solid organ transplant or bone marrow allograft) requiring concurrent use of any systemic immunosuppressants or steroids.\n5. Chronic active hepatitis B or C and HIV.",{"count":65,"type":20},55,[67],"PHASE1","The main objectives of this study are to determine the feasibility and safety of Belzupacap Sarotalocan (AU-011, bel-sar) treatment of bladder cancer utilizing focal injections with or without laser application.",[70,26,71,72,73,74],"Non-muscle-invasive Bladder Cancer","Non-Muscle Invasive Bladder Carcinoma","Non-Muscle Invasive Bladder Neoplasms","Non-Muscle Invasive Bladder Urothelial Carcinoma","Urothelial Carcinoma Bladder",[26,76,77,78,79,80,81,82,83],"TURBT","Intramural","Belzupacap Sarotalocan","Intratumoral","urothelial","bladder cancer","bel-sar","AU-011","RECRUITING","2026-04-13",{"date":87,"type":31},"2026-04-15",{"date":89,"type":31},"2022-09-26",{"date":91,"type":20},"2027-03",{"name":93,"class":38},"Aura Biosciences",17,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},"100577643","phase-1-resq133a-nmibc-intravesical-recombinant-mycobacterium-rmbcg-in-participants-with-nmibc-eligible-to-receive-intravesical-tice-bcg-100577643","NCT06800963","ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG","ResQ133A-NMIBC: Phase 1\u002F2 Clinical Trial of Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG","Inclusion Criteria:\n\nParticipants must meet ALL of the following criteria for inclusion in the study:\n\n1. Male or female participants 18 years of age or older.\n2. Histologic confirmation of BCG naïve non-muscle invasive urothelial carcinoma of the bladder (mixed histology tumors allowed if urothelial histology is predominant histology) AND either i) histologically confirmed presence of NMIBC CIS (with or without Ta\u002FT1 papillary disease) OR ii) primary or recurrent stage Ta and\u002For T1 papillary tumors following transurethral resection (TUR).\n3. Absence of resectable disease after TURBT procedures (residual CIS acceptable; participants with T1 tumors must undergo repeat resection and biopsy \\[inclusive of muscularis propria\\] of the T1 tumor site if initial biopsy did not include muscularis propria).\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n5. Voluntary written informed consent and agreement to comply with all protocol specified procedures and follow-up evaluations.\n\nExclusion Criteria:\n\nParticipants with ANY of the following criteria are excluded from participation in the study:\n\n1. Life expectancy \\\u003C2 years\n2. Any of the following clinical laboratory values at the time of enrollment:\n\n   1. Absolute neutrophil count (ANC) \\\u003C800\u002FμL\n   2. Platelets \\\u003C 50,000\u002FμL\n   3. Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (aspartate aminotransferase \\[AST\\] or alanine aminotransferase \\[ALT\\]) \\> 2 X upper limit of normal (ULN)\n   4. Renal insufficiency as indicated by a creatinine level \\>3 X ULN\n3. 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; and 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.\n4. Symptomatic congestive heart failure (CHF), New York Heart Association (NYHA) Class III or IV heart failure or other clinical signs of severe cardiac dysfunction.\n5. Severe\u002Funstable angina pectoris, or myocardial infarction within 6 months prior to study entry.\n6. History or evidence of uncontrollable central nervous system disease.\n7. Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.\n8. Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions.\n9. Ongoing chronic systemic steroid therapy required (\\>10 mg oral prednisone daily or equivalent).\n10. 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 30 days 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.\n11. Participants currently receiving investigational or commercial anticancer agents or anticancer therapies other than rMBCG and supportive care therapies for active disease.\n12. Concurrent use of other investigational agents (not including FDA authorized drugs for the prevention and treatment of COVID-19).\n13. 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.","85 Years",{"count":104,"type":20},40,[67,106],"PHASE2","This is a phase 1\u002F2, open-label, multicenter study of intravesical Recombinant Mycobacterium Bacillus Calmette-Guérin (BCG) in participants with Non-muscle invasive bladder cancer (NMIBC) who have not received Bacillus Calmette-Guérin and have histologically confirmed presence of Carcinoma in situ (CIS) or have primary or recurrent stage Ta and\u002For T1 papillary tumors following Transurethral resection.",[26],"2026-03-26",{"date":111,"type":31},"2026-03-27",{"date":113,"type":31},"2025-10-15",{"date":115,"type":20},"2028-02",{"name":55,"class":38},9,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":4},"100627182","phase-1-the-study-is-to-evaluate-the-safety-and-tolerability-of-spgl008-alone-or-in-combination-with-bcg-in-the-patients-with-nmibc-and-to-determine-the-rp2d-of-spgl008-alone-or-in-combination-with-bcgto-evaluate-the-preliminary-efficacy-of-spgl008-alone-or-in-combination-with-bcg-100627182","NCT07445308","The Study is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With NMIBC, and to Determine the RP2D of SPGL008 Alone or in Combination With BCG.To Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.","Phase I\u002FII Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of SPGL008 as Monotherapy or in Combination With BCG in Patients With Non-Muscle-Invasive Bladder Cancer","Inclusion Criteria:\n\n1. Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent in writing;\n2. Age ≥ 18 years old, gender is not limited;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;\n4. Expected survival time ≥ 2 years;\n5. High-risk NMIBC diagnosed by previous pathological biopsy\n6. ineligible or unwilling to undergo radical cystectomy;\n7. The level of organ function is good.\n\nExclusion Criteria:\n\n1. Currently receiving study treatment in other clinical trials or less than 4 weeks from last participation to the first administration of this study;\n2. Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration;\n3. Previous medical history or examination suggests active tuberculosis within 1 year prior to the first dose;\n4. Serious infection within 4 weeks before the first administration, or undefined fever\\>38.5 ℃ during screening\u002Fbefore the first administration;\n5. Obvious urinary tract infections and gross hematuria, indicating safety issues assessed by the investigators;\n6. Patients who discontinued treatment due to adverse reactions such as toxemia, systemic infection or urinary incontinence during previous BCG treatment",{"count":126,"type":20},120,[67,106],"The goal of clinical trial is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With on-Muscle-Invasive Bladder Cancer.\n\nThe main questions it aims to answer are:\n\n1. Determine the recommend Phase II dose of SPGL008 Alone or in Combination With BCG.To\n2. Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.",[26],"2026-03-02",{"date":132,"type":31},"2026-03-03",{"date":134,"type":20},"2026-03-12",{"date":136,"type":20},"2029-12-21",{"name":138,"class":38},"Shenyang Sunshine Pharmaceutical Co., LTD.",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":167},"100608920","phase-3-dvbcg-in-her2-expressing-bcg-nave-high-risk-nmibc-100608920","NCT07207824","DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC","A Phase III Randomized Controlled Trial of Disitamab Vedotin (DV) Combined With Bacillus Calmette-Guérin (BCG) in BCG-Naïve Patients With HER2-Expressing, High-Risk Non-Muscle-Invasive Bladder Cancer","HERO","Inclusion Criteria\n\n1. Age ≥ 18 years.\n2. Histologically confirmed high-risk, non-muscle-invasive urothelial carcinoma of the bladder (UCC) (with \\>50% urothelial carcinoma as the predominant histological component), defined by the presence of any of the following: a. T1 tumor; b. High-grade Ta tumor; c. Carcinoma in situ (CIS).\n3. Complete resection of all Ta\u002FT1 papillary lesions (including patients with concomitant CIS). The most recent Transurethral Resection of Bladder Tumor (TURBT) must have been performed within 12 weeks prior to randomization. A second TURBT was required if indicated per current local applicable guidelines.\n4. HER2 expression (IHC 1+\u002F2+\u002F3+) as confirmed by immunohistochemistry (IHC) testing at the local institution's pathology department.\n5. Unwillingness or ineligibility to undergo radical cystectomy.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2.\n7. Signed informed consent form (ICF).\n\nExclusion Criteria\n\n1. Histologically confirmed evidence of muscle-invasive (T2 or higher), locally advanced, or metastatic urothelial carcinoma, or the presence of concurrent extravesical non-muscle-invasive urothelial carcinoma.\n2. Histopathological findings of pure small cell carcinoma, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder.\n3. History of upper tract urothelial carcinoma (except for cases with no recurrence within 2 years following radical treatment for UTUC).\n4. Prior therapy with any other type of HER2-targeted inhibitor.\n5. Major surgery within 2 weeks prior to randomization.\n6. Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.",{"count":148,"type":20},182,[23],"The purpose of this study is to learn about the safety and effects of the study medicine (Disitamab Vedotin) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk. Each participant was assigned to one of two study treatment groups: One group is given Disitamab Vedotin and BCG.The second group is given BCG only and will not receive Disitamab Vedotin.",[152,26],"Bladder (Urothelial, Transitional Cell) Cancer",[26,154,155,156],"disitamab vedotin","HER2","BCG","2025-09-28",{"date":159,"type":31},"2025-10-06",{"date":161,"type":20},"2025-12-01",{"date":163,"type":20},"2030-12-01",{"name":165,"class":166},"Fudan University","OTHER",1,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":176,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":180,"conditions":181,"keywords":182,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":167},"100597928","phase-1-a-tumor-immune-biomarker-guided-approach-for-improving-response-to-bcg-in-patients-with-high-risk-nmibc-100597928","NCT07064863","A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC.","BCG-TIME: Improving Response to Bacillus Calmette Guerin Immunotherapy in High-risk Non-muscle Invasive Bladder Cancer Via a Tumor Immune MicroEnvironment Based Biomarker.","BCG-TIME","Inclusion Criteria:\n\n* Patients with an initial diagnosis of NMIBC without previous exposure to BCG immunotherapy (BCG-naive).\n* Patients with pathologic diagnosis of Ta or T1 high grade NMIBC with or without CIS.\n* Participants older than 65 years of age.\n\nExclusion Criteria:\n\n* Patients with prior exposure to BCG immunotherapy.\n* Immunosuppressed patients on steroids, transplants etc.","65 Years",{"count":178,"type":20},31,[67,106],"This study is being conducted to establish a novel tumor tissue- and blood-based biomarker test to assess early systemic and local response to immunomodulation by BCG immunotherapy in patients with high-risk non-muscle invasive bladder cancer. Responses will be compared between patients with high-risk NMIBC who are being treated with standard of care BCG therapy and those treated with combination chemotherapy. Local and systemic immune monitoring assays will allow early identification of patients who will not benefit from BCG immunotherapy.",[26,73,152,74],[156,26,183,184,185,186,187],"Gemcitabine","Tumor Immune MicroEnvironment","Systemic immunity","Mucosal immune response","Immune Biomarker","2025-07-14",{"date":190,"type":31},"2025-07-17",{"date":192,"type":20},"2025-08-01",{"date":194,"type":20},"2027-07-31",{"name":196,"class":166},"Queen's University",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":203,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":206,"phases":4,"briefSummary":207,"conditions":208,"keywords":211,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":167},"100592318","a-multicenter-prospective-cohort-study-on-monitoring-recurrence-of-urothelial-carcinoma-based-on-detection-of-urinary-microscopic-residual-disease-mrd-100592318","NCT06991868","A Multicenter Prospective Cohort Study on Monitoring Recurrence of Urothelial Carcinoma Based on Detection of Urinary Microscopic Residual Disease (MRD)","Cohort I:\n\nInclusion Criteria:\n\n* patients ≥18 years of age with full civil capacity at the time of signing the informed consent form;\n* patients who provide a urine sample for MRD testing at the time of undergoing postoperative review;\n* Pathologic type: required to be a pathologically confirmed uroepithelial tumor with a predominantly urothelial tumor with a primary site in the upper urinary tract (including the renal pelvis and ureters), and permitted to contain no more than 50% squamous differentiation, adenomatous differentiation, or sarcomatoid differentiation and are pT3\u002F4 or any TpN+.\n\nExclusion Criteria:\n\n* Pathology after radical surgery that does not meet the criteria for enrollment;\n* Predictable inability to meet the criteria for regular review at our center within 1 year postoperatively;\n* Disagreement with regular cystoscopy and\u002For imaging (at least completion of one of CT or MR or PET\u002FCT, with intervals between reviews as well as the specific items to be determined by the clinician);\n* Already definite recurrence or metastasis;\n* Concomitant combination of other active malignant neoplastic disease or a history of other malignant neoplastic disease within 5 years (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment)\n\nCohort II:\n\nInclusion Criteria:\n\n* patients aged ≥18 years at the time of signing the informed consent form with full civil capacity;\n* patients who provided a urine sample for central testing when they underwent postoperative review;\n* Pathological type: a pathologically confirmed predominantly uroepithelial tumor with a primary site in the bladder is required, and is permitted to contain no more than 50% squamous differentiation, or adenoidal differentiation carcinoma in situ is permitted to be present or only in situ and the pathologic stage may be T1, Ta, or Tis (Cis)\n\nExclusion Criteria:\n\n* TUR pathology that does not meet the enrollment criteria;\n* predictable inability to meet the regular review at our center within 1 year postoperatively;\n* disagreement with regular cystoscopy and\u002For imaging (the content and type of imaging will be determined by the clinician);\n* definite recurrence or metastasis already exists;\n* concurrent combination of other active malignant neoplastic disease or a 5-year history of other malignant neoplastic disease history (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment)\n\nCohort III:\n\nInclusion Criteria:\n\n* patients aged ≥18 years at the time of signing the informed consent form with full civil capacity;\n* patients providing urine samples for centralized testing prior to each cycle of treatment during neoadjuvant therapy;\n* pathology type: a predominantly uroepithelial tumor with a TUR surgical pathology primary site in the bladder is required, and is permitted to contain no more than 50% squamous, adenomatous, or sarcomatoid differentiation (iii) Patients with pathologic stage T2 or MIBC on comprehensive imaging despite pathologic stage T1;\n* Radical cystectomy after neoadjuvant therapy, including bladder, prostate, and seminal vesicles in men and bladder and uterus in women;\n* lymph node dissection at least to the extent of the standard dissection for bladder cancer (including the area of the common iliac arteries below the bifurcation of the iliac arteries bilaterally and the area between the ipsoas and genitofemoral nerve to the ureter);\n* the presence of evaluable lesions on imaging based on RECIST 1.1 criteria prior to neoadjuvant therapy.\n\nExclusion Criteria:\n\n* TUR pathology that does not meet enrollment criteria;\n* does not undergo radical total cystectomy or standard surgical scope;\n* receives less than 2 cycles of neoadjuvant therapy;\n* does not undergo regular imaging evaluations during preoperative neoadjuvant therapy;\n* has no evaluable lesions prior to neoadjuvant therapy;\n* already has definitively present distant metastases;\n* concurrently combines other active malignant neoplastic disease or a history of other malignant neoplastic disease within 5 years (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment).\n\nCohort IV:\n\nInclusion Criteria:\n\n* patients aged ≥18 years at the time of signing the informed consent form with full civil capacity;\n* patients to provide a urine sample for centralized testing at each review visit;\n* pathology type: the TUR surgical pathology is required to be a predominantly urothelial tumor with a primary site in the bladder, and is allowed to contain no more than 50% squamous, adenomatous, or sarcomatous differentiation;\n* there should be a centralized imaging to assess a clinical assessment of MIBC prior to TMT treatment;\n* patients assessed as clinically CR after undergoing TMT who can continue to retain their bladder and do not require salvage cystotomy.\n\nExclusion Criteria:\n\n* TUR pathology that does not meet the inclusion criteria;\n* predictable inability to meet the regular review at our center within 1 year after surgery;\n* no pre-treatment imaging at our center;\n* disagreement with regularity of receiving imaging (the clinician decides on the content and type of imaging);\n* residual lesions or metastases that are already clearly present;\n* concurrent combination of other active malignant neoplastic diseases or a history of other malignant neoplastic diseases within 5 year history of other malignant neoplastic disease (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment).","18 Months",{"count":205,"type":20},300,"OBSERVATIONAL","This was a multicenter, prospective, non-interventional, observational cohort study, and the enrolled patients were divided into four cohorts: cohort I was patients with high-risk upper tract urothelial carcinoma (UTUC) (pT3-4 or N+); cohort II was patients with non-muscle invasive bladder cancer (NMIBC) (including low-risk, intermediate-risk, and high-risk\u002Fvery-high-risk); cohort III was patients with muscle-invasive bladder cancer (MIBC) to receive neoadjuvant therapy; and cohort IV was patients evaluated for complete response (CR) after standard trimodality therapy (TMT) treatment (i.e. patients with successful bladder preservation). Primary Objectives Cohorts I and IV: MRD score to assess the sensitivity and specificity of imaging recurrence\u002Fmetastasis; Cohort II: MRD score to assess the sensitivity and specificity of tumor recurrence; Cohort III: MRD score to assess the sensitivity and specificity of tumor remnants. Secondary Objectives Cohorts I and IV: MRD score to assess the sensitivity and specificity of imaging recurrence subgroup and metastasis subgroup; Cohort II: MRD score to assess the sensitivity and specificity of different grades and stages of recurrent tumors; Cohort III: MRD scores to assess the sensitivity and specificity of different grades and stages of residual tumors.",[26,209,210],"MIBC","UTUC",[212,213,214],"high-risk upper tract urothelial carcinoma (UTUC) (pT3-4 or N+)","non-muscle invasive bladder cancer (NMIBC) (including low-risk, intermediate-risk, and high-risk\u002Fvery-high-risk)","muscle-invasive bladder cancer (MIBC)","2025-05-27",{"date":217,"type":31},"2025-05-28",{"date":219,"type":31},"2024-03-01",{"date":221,"type":20},"2026-05-31",{"name":223,"class":166},"Peking University First Hospital",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":16,"minAge":231,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":21,"phases":235,"briefSummary":237,"conditions":238,"keywords":242,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":250,"leadSponsor":252,"locationsCount":167},"100591612","anesthesia-modality-and-oncologic-outcomes-in-high-risk-nmibc-a-randomized-trial-100591612","NCT06982690","Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial","Impact of Anesthesia Modality on Recurrence and Progression in High-Risk Non-Muscle Invasive Bladder Cancer: A Randomized Controlled Trial Comparing Spinal Versus General Anesthesia","Inclusion Criteria:\n\n* Age ≥40 years for male subjects or postmenopausal female subjects\n* ECOG performance status 0-2\n* Patients with suspected or newly diagnosed UBUC\n* ASA I or II\n* Patients with any other adequately treated Stage I or II cancer except UC, from which the subject has been disease free for 5 years\n* Adequate renal function, defined as a serum creatinine (Cre) concentration ≤ the institutional ULN\n* Adequate hepatic function, defined as total bilirubin ≤ the institutional ULN and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ the institutional upper limit of normal (ULN)\n\nExclusion Criteria:\n\n* Patients with prior or concurrent UC involving the renal pelvis, ureter or urethra\n* Patients with clinical evidence of MIBC or mUC\n* Immunocompromised or immunosuppressed patients\n* Patients with chronic use of anti-inflammatory agents or beta-blockers\n* Patients with difficult airways or other significant cardiovascular comorbidities (severe aortic stenosis, significant pulmonary disease, CHF) who are intolerant to GA\n* Patients with elevated intracranial pressure (ICP), primarily due to intracranial mass and trauma or infection at the site of SA\n* Patients with a serious uncontrolled medical disorder (e.g., trauma, fracture) or active infection that would impair their ability to receive spinal or GA\n* Patients with known allergies to propofol, fentanyl, sevoflurane, or bupivacaine\n* Subjects with a known history or family history of malignant hyperthermia\n* Subjects with bleeding diathesis","20 Years","80 Years",{"count":234,"type":20},370,[236],"NA","To demonstrate the superior efficacy of spinal anesthesia (SA) versus general anesthesia (GA) according to the delay of time to recurrence in high-risk NMIBC patients up to Week 104 after TURBT.",[26,76,152,239,240,241],"Bladder Cancer Recurrence","Anesthesia, General","Anesthesia,Spinal",[81,243,244,245,76],"general anesthesia","spinal anesthesia","recurrence","2025-05-13",{"date":248,"type":31},"2025-05-21",{"date":192,"type":20},{"date":251,"type":20},"2029-11-30",{"name":253,"class":166},"National Taiwan University Hospital",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":21,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":167},"100584460","immediate-chemotherapy-following-resection-for-high-risk-non-muscle-invasive-bladder-cancer-100584460","NCT06889623","Immediate Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer","Impact of Immediate Cisplatin\u002FGemcitabine Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer: an Open-label, Single-arm, Prospective Trial","HIGCrecur","Inclusion Criteria:\n\n* Patients with a history and cystoscopy results indicating high-risk NMIBC:\n\n  * High-grade T1\n  * Any recurrent high-grade Ta\n  * High-grade Ta \\& Tumor diameter greater than 3 cm or multifocal\n  * Any CIS\n  * Any BCG failure in patients with high-grade disease\n  * Any variant histology\n  * Any LVI\n  * Any high-grade prostatic urethral involvement\n* Patients in generally good condition with a follow-up period of 2 years\n\nExclusion Criteria:\n\n* Bladder cancer other than UC\n* MIBC or benign diseases\n* Incomplete tumor resection\n* Active infection\n* Concurrent upper urinary tract or prostatic urethral UC\n* Previous systemic chemotherapy, immunotherapy, or radiotherapy\n* Leukopenia\u002Fthrombocytopenia\n* Serum creatinine greater than twice the normal level\n* Uncontrollable urinary tract infection",{"count":263,"type":20},72,[236],"Residual tumors after transurethral resection of bladder tumors (TURBT) range from 17-70%, and floating tumor cells from traditional segmental resection may lead to recurrence if they re-implant in the bladder wall. Immediate systemic chemotherapy post-surgery aims to eliminate microlesions promptly and minimize recurrence risk, yet its safety and efficacy require further exploration. This prospective, single-arm study delves into evaluating the efficacy and safety of immediate postoperative systemic chemotherapy in patients with suspected high-risk non-muscle-invasive bladder cancer.",[26],"2025-03-16",{"date":269,"type":31},"2025-03-21",{"date":271,"type":31},"2024-06-01",{"date":273,"type":20},"2028-06-01",{"name":275,"class":166},"Changhai Hospital",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":232,"enrollmentInfo":282,"targetDuration":4,"studyType":21,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":167},"100572593","a-bladder-sparing-treatment-strategies-of-large-volume-non-muscle-invasive-bladder-cancer-100572593","NCT06735287","A Bladder-Sparing Treatment Strategies of Large-Volume Non-Muscle-Invasive Bladder Cancer","Inclusion Criteria:\n\n\\- Diagnosis of large non-muscle-invasive bladder cancer: Tumor size ≥5 cm, ≤3 tumors, pre-TURBT VI-RADS score \\\u003C3, or biopsy confirms non-muscle-invasive urothelial carcinoma.\n\nAbility to tolerate neoadjuvant chemotherapy and immunotherapy: Sufficient heart, bone marrow, liver, and kidney function (according to clinical trial center normal values), no severe hematologic abnormalities or organ dysfunction (heart function 0-2, WBC ≥3.5×10⁹\u002FL, neutrophil count ≥1.5×10⁹\u002FL, PLT ≥75.0×10⁹\u002FL, HGb ≥80 g\u002FL; liver function: total bilirubin ≤1.5×ULN, AST and ALT ≤2.5×ULN; kidney function: creatinine ≤1.5×ULN, or GFR ≥60 ml\u002Fmin if creatinine \\>1.5×ULN).\n\nECOG performance status: 0 or 1. No history of other malignancies. Able to receive regular mitomycin C bladder instillation therapy after TURBT. Male or female, aged ≥18 and \\\u003C80 years. Voluntary participation with written informed consent, and ability to understand and comply with study requirements, including regular follow-up.\n\nExclusion Criteria:\n\n* Preoperative imaging assessment with VI-RADS ≥3. Postoperative pathology showing non-urothelial carcinoma (e.g., adenocarcinoma, squamous cell carcinoma, small cell carcinoma, or mixed tumors), or urothelial carcinoma ≥T2.\n\nPresence of lymph node and\u002For distant metastases. Allergy or hypersensitivity to treatment drugs, or patients with autoimmune diseases.\n\nAny condition deemed by the investigator to potentially harm the participant or prevent them from meeting or fulfilling study requirements.",{"count":283,"type":20},60,[236],"Bladder cancer is a common malignancy in the urinary system, ranking 11th in cancer incidence in China (3.48\u002F100,000), with male incidence ranking 8th (5.70\u002F100,000). It is classified as non-muscle-invasive bladder cancer (NMIBC) or muscle-invasive bladder cancer (MIBC) based on muscle involvement. About 75% of patients are initially diagnosed with NMIBC, with Ta, T1, and Tis stages comprising 70%, 20%, and 10%, respectively.\n\nWith the advancement of magnetic resonance imaging (MRI), its role in bladder cancer diagnosis and staging has expanded. Multiparametric MRI (MpMRI) enhances staging accuracy with better anatomical visualization. In 2018, Valeria et al. introduced the VI-RADS scoring system, which uses MpMRI to predict tumor stage. Retrospective studies by Wang et al. found that all tumors with a VI-RADS score of 1 were NMIBC, and 95.1% of tumors with a score of 2 were also NMIBC. A VI-RADS score of ≤2 can be used to identify NMIBC with high sensitivity.\n\nNMIBC shows varied risks for recurrence and progression based on tumor characteristics like size, stage, grade, and multiplicity. The European Association of Urology (EAU) risk stratification system, established in 2021, classifies NMIBC into low-, intermediate-, high-, and very-high-risk groups. Transurethral resection of bladder tumor (TURBT) is the primary diagnostic and therapeutic approach for most NMIBC cases. However, residual tumors can remain after the first TURBT. For Ta and T1 tumors, 17%-72% and 33%-78% of cases show residual disease during second resection, respectively. Re-staging TURBT for T1 tumors improves prognosis. Studies show that second TURBT offers longer recurrence-free survival (47 months) compared to a single TURBT (12 months). The 5-year progression rate was 6.5% with second TURBT, compared to 23.5% with a single procedure.\n\nFollowing TURBT, floating and residual tumor cells may lead to recurrence. Immediate postoperative bladder instillation of chemotherapy (e.g., pirarubicin, epirubicin, doxorubicin, mitomycin C, gemcitabine) significantly reduces recurrence in low-risk NMIBC but is less effective for intermediate- and high-risk NMIBC. For intermediate-risk NMIBC, maintenance chemotherapy is recommended, and for high-risk NMIBC, BCG immunotherapy is preferred. Both maintenance chemotherapy and BCG instillation reduce recurrence in these groups. Mitomycin C offers comparable efficacy to BCG with fewer side effects.\n\nFor patients in the very-high-risk group, immediate radical cystectomy is recommended because delayed cystectomy leads to poorer cancer-specific survival. High-risk NMIBC patients may undergo 1-3 years of BCG therapy or immediate cystectomy if necessary.\n\nLarge-volume NMIBC (≥5 cm) presents significant challenges in treatment. TURBT for large tumors often leads to difficulties in resection due to excessive bleeding, unclear vision, and increased risk of bladder wall injury. Larger tumors also increase the risk of tumor cell seeding and metastasis. Tumor size (≥3 cm) is an independent risk factor for early recurrence and progression, leading some experts to recommend immediate radical cystectomy for large-volume NMIBC.\n\nRadical cystectomy is a high-risk procedure with complication rates of 28%-64% and mortality rates of 2.5%-2.7%. It also requires urinary diversion, which can significantly impact a patient's physical, psychological, and social well-being. Patients often face lifelong use of urinary collection devices, reducing their quality of life. Given the impact of radical cystectomy, bladder-sparing strategies have gained attention. These approaches aim to preserve the bladder while controlling tumor growth, maintaining the patient's quality of life.\n\nCurrently, no formal guidelines exist for bladder-sparing treatment of large-volume NMIBC. However, a 2022 Chinese consensus emphasizes maximal TURBT followed by adjuvant therapy to reduce recurrence and progression. Intravesical chemotherapy, particularly BCG and mitomycin C, is a key part of postoperative management. In the era of immunotherapy, PD-1\u002FPD-L1 inhibitors are emerging as essential components of bladder-sparing strategies. Pembrolizumab, for example, has shown a 41% complete response rate in BCG-unresponsive NMIBC, leading to its FDA approval for carcinoma in situ patients who are ineligible or unwilling to undergo radical cystectomy.\n\nAlthough neoadjuvant chemotherapy is not yet included in NMIBC guidelines, its success in MIBC suggests potential benefit for NMIBC. Neoadjuvant chemotherapy improves survival by 5%-10% and reduces mortality by 16%-33%. After achieving a pathological complete response (pT0), patients can avoid radical cystectomy, with a 5-year survival rate of 90%.\n\nThis study aims to explore the feasibility of bladder-sparing treatment for large-volume NMIBC, balancing quality of life with oncological outcomes.",[287,26],"Bladder Cancer",{"date":289,"type":31},"2025-03-18",{"date":291,"type":31},"2024-12-01",{"date":293,"type":20},"2027-12-31",{"name":295,"class":166},"The First Affiliated Hospital with Nanjing Medical University",{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":102,"enrollmentInfo":303,"targetDuration":4,"studyType":21,"phases":304,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":167},"100564568","phase-2-a-clinical-trial-evaluating-the-efficacy-and-safety-of-disitamab-vedotin-plus-tislelizumab-combined-with-re-turbt-in-the-treatment-of-her-2-high-expression2-3-non-muscle-invasive-bladder-cancer-at-high-risk-and-very-high-risk-100564568","NCT06630871","A Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk.","A Prospective, Multicenter, Single-Arm, Phase Ⅱ, Exploratory Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk.","Inclusion Criteria:\n\n* Voluntarily participate in the experiment and sign a written informed consent form；\n* Patients should be aged between 18 and 85 years, with no gender restrictions, no severe organ failure such as heart, lung, or brain, and an expected survival period of one year or more;\n* Complete the relevant screening tests (routine blood test, coagulation function, liver and kidney function, infectious disease screening, 12-lead electrocardiogram, urinary system ultrasound, pelvic enhanced CT or MRI, and tissue pathology examination), and have no contraindications for TURBt surgery;\n* Eastern Cooperative Oncology Group (ECOG) score: 0-2 points;\n* Previous systemic therapy without systemic immunity\u002FADC drugs；\n* Histologically confirmed non muscle invasive bladder cancer (NMIBC), with or without carcinoma in situ (CIS), the main pathological type is urothelial carcinoma, including other specific histopathological types, but urothelial carcinoma dominates (at least 50%). Patients with AUA classification of high-risk and extremely high-risk recurrence or progression risk by the American Urological Association, and with immunohistochemical results of Her2 being 3+or 2+, who have undergone maximal TURBt within 6 weeks.\n\nExclusion Criteria:\n\n* Any of the following circumstances: those with immune deficiency or impairment (such as AIDS patients), who are using immunosuppressive drugs or radiotherapy, and who may cause systemic BCG disease reaction; Individuals who are allergic to the components of BCG vaccine; Patients with fever and acute infectious diseases, including active tuberculosis, or those receiving anti tuberculosis treatment; Accompanied by severe chronic cardiovascular and cerebrovascular diseases or chronic kidney disease;\n* Patients with other urogenital system tumors or other organ tumors;\n* Patients with AUA grading of low-risk, moderate risk NMIBC, or myometrial invasive bladder urothelial carcinoma (T2 stage or above), or immunohistochemistry Her2 negative or 1+patients;\n* Individuals who have received chemotherapy, radiation therapy, or immunotherapy within the past 4 weeks;\n* Pregnant or lactating women, women of childbearing age who have not taken effective contraceptive measures, and those planning to conceive during the trial period (including male subject partners);\n* Patients with severe urethral stricture who cannot undergo cystoscopy, those with a history of bladder contracture or functional bladder volume less than 100mL;\n* Patients with various mental disorders, severe coagulation function, liver and kidney function, hematopoietic dysfunction, etc. who cannot tolerate surgical treatment;\n* Participated in clinical trials of other drugs within the past 3 months prior to enrollment;\n* Known opioid or alcohol dependent individuals;\n* Researchers believe that there may be any situation that increases the risk to participants or interferes with the execution of clinical trials.",{"count":104,"type":20},[106],"This prospective, multicenter, single-arm phase II trial aims to evaluate the clinical efficacy and safety of the combination therapy of Disitamab Vedotin with Tislelizumab and a second transurethral resection for the treatment of high-risk, very high-risk NMIBC with HER2 2+-3+.",[26],"2024-10-08",{"date":309,"type":31},"2024-10-10",{"date":311,"type":20},"2024-10",{"date":313,"type":20},"2028-10",{"name":315,"class":166},"Fujian Medical University Union Hospital",{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":21,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":167},"100561285","phase-1-shr-1501-combined-with-shr-2005-for-high-risk-non-muscle-invasive-bladder-cancer-which-is-not-completely-resectable-by-turbt-100561285","NCT06588179","SHR-1501 Combined With SHR-2005 for High-Risk Non-Muscle Invasive Bladder Cancer Which is Not Completely Resectable by TURBt","Phase Ib\u002FII Clinical Study of SHR-1501 Combined With SHR-2005 in the Treatment of Patients With High-Risk Non-Muscle Invasive Bladder Cancer Which is Not Completely Resectable by TURBt","Inclusion Criteria:\n\n1. Age ≥18 years old, both genders\n2. Previous pathological biopsy was diagnosed as high-risk NMIBC\n3. Tumors cannot be completely resected by TURBT（at least 2 senior urologists assessed that the lesion area is too extensive to be completely resected）\n4. Ineligible or unwilling to undergo radical cystectomy\n5. TURBT was performed within 6 weeks\n6. Agreed to provide cystoscopic biopsy specimens for review\n7. ECOG performance status of 0-2\n8. Life expectancy ≥ 2 years\n9. Adequate organ function：\n\n   1. Hematological indexes: ANC ≥1.5x10\\^9\u002FL, PLT ≥100x10\\^9\u002FL, Hb ≥ 90 g\u002FL;\n   2. Liver function: TBIL ≤1.5 ULN; ALT and AST≤2.5 ULN; Albumin \\> 3g\u002FdL\n   3. Renal function: Cr≤1.5 ULN or creatinine clearance ≥ 60 ml\u002Fmin (Cockcroft-Gault formula); if proteinuria ≥++, requiring 24-hour urine protein level ≤1.0g;\n   4. ECG: females QTcF ≤470ms and males ≤450ms\n   5. Cardiac ultrasound: LVEF≥50%\n   6. Coagulation: INR or PT ≤1.5 ULN，APTT≤1.5 ULN\n10. Female or male subjects of childbearing age who have not undergo surgical sterilization shall agree to use contraceptive measures (such as intrauterine device and contraceptive pill) during the study treatment period and within 3 months after the end of the study treatment period, and both female subjects and female partners of male subjects should use highly effective contraceptive methods; the Female subjects of childbearing age who have not undergone surgical sterilization must have a negative serum HCG test result within 7 days prior to the first administration and must be non-lactating.\n11. Volunteered to join the study, signed the informed consent, and had good compliance with follow-up\n\nExclusion Criteria:\n\n1. Previous pathological biopsy was diagnosed with muscle-invasive bladder cancer at T2 or higher stages\n2. Received any other intravesical chemotherapy treatment within 2 weeks or received any other clinical drugs within 4 weeks\n3. History of allergy to any of the study drugs or study drug components\n4. Upper urinary tract tumor detected by CTU or MRU during screening period or other concomitant malignant tumors within 5 years before the first administration\n5. Previously received any TNFR agonist antibody therapy(such as OX40, CD27, CD357 antibodies), IL-15 agonist antibody therapy, or IL-2 agonist antibody therapy\n6. Oversize surgery or severe trauma within 4 weeks before the first use of research drugs\n7. Previously discontinued bladder instillation therapy due to adverse reactions such as sepsis, systemic infection, or urinary incontinence\n8. Active\u002Funcontrolled impairment of the urogenital system, kidneys, liver, gallbladder, cardiovascular system, gastrointestinal tract, nervous system, or hematopoietic system, which may lead to complications for the subject when receiving intravesical therapy and\u002For general anesthesia\n9. A history of interstitial lung disease or non-infectious pneumonitis requiring treatment with glucocorticoids, or current presence of interstitial pneumonitis or non-infectious pneumonitis, or a history of other severe pulmonary diseases\n10. A history of immunodeficiency, including HIV seropositivity, other acquired or congenital immunodeficiency diseases, a history of organ transplantation, or current use of immunosuppressants\n11. History of clinically significant cardiovascular disease within 6 months before the first administration\n12. Investigator-assessed concern for medication safety; severe infections requiring antibiotic, antiviral or antifungal drug control; and unexplained fever \\> 38.5°C within 2 weeks\n13. Patient with active hepatitis B (HBeAg positive and HBV DNA≥500 IU\u002FmL), hepatitis C (HCV antibody positive and HCV RNA higher than the detection limit of the analytical method)\n14. Adverse reactions of previous anti-tumor treatment have not recovered to Grade≤1 per NCI-CTCAE v5.0\n15. The presence of any other conditions that the investigator deems inappropriate to participate in this study, including serious physical or mental illness, abnormal laboratory tests, and other factors that may increase the risk of participating in the study, or interfere with the results of the study",{"count":324,"type":20},58,[67,106],"This is a single-center, single-arm, phase Ib\u002FII study, aimed at assessing the safety and efficacy of SHR-1501 in combination with SHR-2005 as treatment for patients with high-risk non-muscle invasive bladder cancer (HR NMIBC) which is not completely resectable by transurethral resection of bladder tumor (TURBt).",[26],"2024-09-05",{"date":330,"type":31},"2024-09-19",{"date":332,"type":20},"2024-10-01",{"date":334,"type":20},"2027-10-01",{"name":165,"class":166},{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":21,"phases":345,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":167},"100511741","phase-2-rc48-adc-in-combination-with-gemcitabine-in-high-risk-nmibc-subjects-100511741","NCT05943379","RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects","An Open-label, Single Arm, Single Center Phase 2 Study of RC48-ADC (IV) in Combination With Gemcitabine(Intravesical) in High Risk NMIBC Subjects (BCG Naïve or BCG Unresponsive) That Expresses HER2 (IHC 1+ and Greater)","Inclusion Criteria:\n\n1\\. Voluntary consent to participate in the study and sign an informed consent form.\n\n2\\. Male or female, age ≥ 18 years. 3. Disease satisfies.\n\n* Diagnosis in accordance with the Chinese Guidelines for the Treatment of Bladder Cancer (2022) high-risk non-muscle invasive bladder cancer (NMIBC) and meeting any of the following ± carcinoma in situ (CIS): 1. stage T1 tumor of any grade; 2. high-grade tumor; 3. multiple and\u002For recurrent tumors, with recurrent tumors excluding low-grade solitary tumors.\n* Histopathological satisfaction of uroepithelial carcinoma predominant by histopathology, confirming the absence of muscular infiltration.\n* Completion of TURBT and resection of all visible lesions within 3 weeks prior to study dosing.\n* Clinical staging (cTa\u002FT1±CIS, N0, M0) and absence of distant metastases as assessed by imaging (which needs to include at least CTU) within 3 months prior to enrollment.\n\n  4\\. 4. Prior BCG treatment.\n  1. Cohort 1 is high-risk NMIBC patients who have not received prior BCG therapy: high-risk NMIBC patients who have not received prior BCG therapy due to subjective and objective conditions, including one of the following 1. patient refusal to receive BCG therapy; 2. presence of contraindications to BCG therapy; 3. BCG inaccessibility.\n  2. Cohort 2 was high-risk NMIBC patients with BCG non-response, and BCG non-response met any of the following: 1. presence of persistent\u002Frecurrent high-risk NMIBC within 12 months (±1 month) of completing adequate BCG therapy; 2. high-grade T1 disease at first assessment after induction phase BCG therapy. Note: Adequate BCG therapy is defined as at least 5 BCG bladder instillations completed within 2 months and at least 2 BCG bladder instillations completed in any 6 consecutive weeks over the next 10 months, i.e., at least \"5+2\" BCG bladder instillations completed over an approximately 12-month period.\n\n  5\\. Subjects who have been assessed by a urologist to be unsuitable for radical bladder cancer surgery or who have refused radical bladder cancer surgery.\n\n  6\\. Subjects whose tumor tissue obtained by TURBT within 3 weeks meets 1+, 2+ or 3+ HER2 expression by immunohistochemistry (IHC) at the study center.\n\n  7\\. ECOG physical status score of 0-2. 8. Adequate cardiac, bone marrow, liver, and renal function, which should meet the following criteria within 7 days prior to study dosing (normal values are based on the clinical trial center).\n* Left ventricular ejection fraction ≥ 50%.\n* Hemoglobin ≥ 9 g\u002FdL.\n* Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL.\n* Platelets ≥ 100×109\u002FL.\n* Serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN).\n* ALT and AST ≤ 2.5×ULN.\n* blood creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 50 mL\u002Fmin calculated according to the Cockcroft-Gault formula method.\n\n  9\\. Female subjects should be surgically sterilized, post-menopausal, or agree to use at least one medically approved contraceptive (e.g., IUD, pill, or condom) during study treatment and for 6 months after the end of the study treatment period, and must have a negative blood pregnancy test within 7 days prior to study enrollment; false-positive results may be excluded by the investigator after enrollment. Male subjects should agree to use at least one medically approved contraceptive during the study treatment period and for 6 months after the end of the study treatment period.\n\n  10\\. be willing and able to comply with the trial and follow-up procedural arrangements.\n\nExclusion Criteria:\n\n1. muscle-invasive bladder cancer (T2 and above) and\u002For with regional lymph nodes and distant metastases\n2. Combined extra-vesical (i.e. urethral, ureteral or renal pelvis) uroepithelial carcinoma.\n3. Received any other antitumor therapy, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc., within 4 weeks prior to study dosing, excluding 1 dose of infusion chemotherapy completed immediately after TURBT.\n4. Have not recovered from an adverse event caused by a previously applied antineoplastic agent to CECAT 5.0 grade 0-1 within 2 weeks prior to the start of study dosing.\n5. Those who have undergone major surgery within 4 weeks prior to the start of study dosing or who are scheduled to undergo major surgery during the trial.\n6. Serum virological tests (based on the normal values of the study center).\n\n   * Positive HBsAg or HBcAb test result with a positive HBVDNA copy number.\n   * Positive HCVAb test result together with a positive HCVRNA test result.\n   * Positive HIVAb test result.\n7. live vaccine received within 4 weeks prior to the start of study dosing or scheduled to receive any vaccine (except novel coronavirus vaccine) during the study period.\n8. heart failure classified as grade 3 or higher by the New York Heart Association (NYHA) of America.\n9. the presence of a serious arterial\u002Fvenous thrombotic event or cardiovascular accident such as deep vein thrombosis, pulmonary embolism, cerebral infarction, cerebral hemorrhage, or myocardial infarction within 6 months prior to study dosing, except for lacunar cerebral infarction that is asymptomatic and does not require clinical intervention\n10. the presence of an active infection requiring systemic treatment, such as active tuberculosis\n11. the presence of active, unstably controlled systemic disease or serious comorbidity as judged by the investigator, including diabetes mellitus, hypertension, cirrhosis, interstitial pneumonia, obstructive pulmonary disease, complications that could cause the subject to undergo intravesical therapy and\u002For general anesthesia\n12. having any other disease, metabolic abnormality, physical examination abnormality or laboratory test abnormality that, in the judgment of the investigator, gives reason to suspect that the patient has a disease or condition that is inappropriate for the use of the study drug or that will affect the interpretation of the study results, or that places the patient at high risk\n13. the presence of an active autoimmune disease requiring systemic therapy (e.g., use of immunomodulatory drugs, corticosteroids, or immunosuppressants) prior to the start of study dosing, allowing for associated replacement therapy (e.g., thyroxine for adrenal or pituitary insufficiency, or replacement therapy with physiologic corticosteroids)\n14. other malignancies within 5 years prior to the start of study dosing, with the following exceptions.\n\n    * Malignancies that can be expected to resolve with treatment (including, but not limited to, adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or radical surgically treated ductal carcinoma in situ of the breast).\n    * Patients with prostate cancer with prior specific treatment (surgery or radiation therapy).\n\n      1. T2N0M0 or earlier stage.\n      2. Gleason score ≤ 7 and prostate-specific antigen (PSA) undetectable for at least 1 year after anti-androgen therapy.\n      3. Patients with viable specific therapy or on active surveillance without specific therapy, with stable disease 1 year prior to study entry.\n15. previous history of allogeneic HSCT or organ transplantation\n16. known hypersensitivity to recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent drug and its components or hypersensitivity to gemcitabine and any excipients\n17. women who are pregnant or breastfeeding.\n18. estimated insufficient patient compliance to participate in this clinical study.",{"count":344,"type":20},85,[106],"In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) who are BCG Naïve or BCG Unresponsive and are considered ineligible for or have refused to undergo radical cystectomy, will receive RC48-ADC in combination with gemcitabine.",[26],"2023-07-10",{"date":350,"type":31},"2023-07-13",{"date":352,"type":31},"2023-06-08",{"date":354,"type":20},"2026-12-01",{"name":356,"class":38},"RemeGen Co., Ltd."]