[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-risk-non-muscle-invasive-bladder-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-risk-non-muscle-invasive-bladder-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,66,91,122],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100559715","phase-2-phase-2-study-to-evaluate-safety-and-efficacy-of-cretostimogene-grenadenorepvec-in-high-risk-nmibc-100559715",false,"NCT06567743","Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC","A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)","Cohort A Key Inclusion Criteria:\n\n* Pathologically confirmed BCG-naïve high-risk high-grade NMIBC (i.e., CIS with or without Ta\u002FT1 disease or high-grade Ta\u002FT1 papillary-only disease without CIS) within 90 days of treatment allocation.\n* All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.\n* Acceptable baseline organ function.\n\nCohort B Key Inclusion Criteria:\n\n* Pathologically confirmed BCG-exposed high-risk high-grade NMIBC (i.e., CIS with or without Ta\u002FT1 disease or high-grade Ta\u002FT1 papillary-only disease without CIS) within 90 days of treatment allocation.\n* All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.\n* Acceptable baseline organ function.\n\nCohort CX Inclusion Criteria\n\n* Pathologically confirmed high-risk high-grade BCG-unresponsive or BCG-exposed NMIBC (i.e., CIS with or without Ta\u002FT1 disease or high-grade Ta\u002FT1 papillary-only disease without CIS) within 90 days of treatment allocation.\n* All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.\n* Acceptable baseline organ function.\n\nKey Exclusion Criteria (Both Cohorts):\n\n* Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer.\n* High-grade urothelial carcinoma in the upper urinary tract or prostatic urethra within 24 months or T2 in upper tract within 48 months or any history of locally advanced\u002F nodal or metastatic disease in the upper urinary tract.\n* Significant immunodeficiency.\n* Pregnant or breastfeeding.\n* Cohort CX Only: serial intravesical gemcitabine within 24 months","ALL","18 Years",{"count":19,"type":20},325,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer.",[26],"High-Risk Non-Muscle-Invasive Bladder Cancer",[28],"Bladder Cancer","RECRUITING","2026-04-06",{"date":32,"type":33},"2026-04-08","ACTUAL",{"date":35,"type":33},"2024-09-16",{"date":37,"type":20},"2027-12-30",{"name":39,"class":40},"CG Oncology, Inc.","INDUSTRY",65,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100630153","phase-1-a-phase-iii-study-of-jl19001-injection-alone-or-in-combination-with-bcg-in-subjects-with-high-risk-non-muscle-invasive-bladder-cancer-100630153","NCT07483970","A Phase I\u002FII Study of JL19001 Injection Alone or in Combination With BCG in Subjects With High Risk Non-Muscle Invasive Bladder Cancer.","JL19001-NMIBC","Inclusion Criteria:\n\n1. Subjects should voluntarily sign the informed consent, and agree to comply with all protocol-specified procedures .\n2. Male or female patients ≥18 years of age at the time of signing the ICF.\n3. Life expectancy ≥ 2 years.\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n5. Previous pathological biopsy was diagnosed as high-risk NMIBC.\n6. Cystoscopy showed complete resection of the lesion or the residual lesion is only CIS within 6 weeks prior to initial administration; For T1 lesions, postoperative pathological results must show the presence of bladder muscle layer.\n7. After fully understanding the benefits, risks, and alternatives of radical cystectomy, the subject voluntarily chooses not to undergo the surgery; or the subject is deemed unsuitable for radical cystectomy by the researcher\n8. Subjects with fertility and their partner should use contraception during the study treatment period and within 12 weeks after the end of the study treatment period. Non-surgical sterilized female subjects of reproductive age must be negative for serum HCG within 7 days prior to initial administration and must be non-lactating.\n\nExclusion Criteria:\n\n* 1\\. Individuals who are allergic to any component of the investigational product.\n\n  2\\. Received surgical treatment or radiotherapy for bladder lesions within 2 weeks prior to initial administration\n\n  3\\. Any of the following clinical laboratory values During the screening period Hematology:absolute neutrophil count (ANC) \\\u003C 1.5 ×109\u002FL, platelets \\\u003C 100 × 109\u002FL, Hemoglobin\\\u003C90 g\u002FL(Within 14 days prior to screening, no whole blood transfusion, component blood transfusion, or drugs such as colony stimulating factors \\[For example: Granulocyte Colony-Stimulating Factor,Granulocyte-Macrophage Colony-Stimulating Factor,Erythropoietin,Thrombopoietin\\] have been administered.) renal function:Creatinine\\> 1.5×upper limit of normal(ULN)or Creatinine Clearance≥ 60mL\u002Fmin(Calculate according to the Cockcroft-Gault formula); liver function(No history of liver protection treatment within 7 days prior to screening examination):Aspartate Aminotransferase \\> 2.5 × ULN;Alanine Aminotransferase \\> 2.5 × ULN;Total Bilirubin \\> 1.5× ULN; ECG examination: QT interval corrected by Fridericia (QTcF) \\> 450ms for males, QTcF \\> 470ms for females; Coagulation function: Activated Partial Thromboplastin Time \\> 1.5 × ULN; International Normalized Ratio \\> 1.5 × ULN; Prothrombin Time \\> 1.5 × ULN;\n\n  4\\. History of or evidence of muscle-invasive, locally advanced, metastatic and\u002For extravesical bladder cancer (inclusive of the prostatic urethra).\n\n  5\\. There are contraindications to cystoscopy and\u002For urethroscopy, such as urethral stricture, urinary tract infection (UTI) (referring to symptomatic infection with positive urine culture), gross hematuria, and small bladder capacity, etc;\n\n  6\\. Bladder dysfunction during the screening period, such as severe urinary incontinence or overactive bladder (OAB); bladder perforation detected during the screening period through cystoscopy or imaging examination;\n\n  7\\. During the screening period, if upper urinary tract tumors are detected during an upper urinary tract examination, or tumors in the prostatic urethra are detected during cystoscopy, or other malignant tumors are found within 5 years of the first dose, with the exception of skin basal cell carcinoma, squamous cell carcinoma, and cervical carcinoma in situ that have achieved complete remission or been effectively controlled through treatment, as well as Stage I\u002FII cancers that have received adequate treatment, or stable prostate cancer that is under active monitoring in complete remission or well-managed through androgen therapy\n\n  8\\. Symptomatic congestive heart failure, New York Heart Association (NYHA) class III or IV heart failure, or other severe cardiac dysfunction, which the investigator deems clinically significant.\n\n  9\\. Severe\u002Funstable angina pectoris, or myocardial infarction within 6 months prior to study entry.\n\n  10\\. History or evidence of uncontrollable central nervous system disease.\n\n  11\\. Past medical history or examination suggests active tuberculosis within 1 year prior to initial administration;\n\n  12\\. Severely infected people who need to be controlled by antibiotics, antivirals or antifungals;\n\n  13\\. Have a history of immunodeficiency, including HIV seropositivity, other acquired or congenital immunodeficiency diseases.\n\n  14\\. The subject had received systemic glucocorticoid treatment within 2 weeks prior to the first administration of the test drug, except for the following situations: the hormone dose was ≤ 10mg\u002Fday in prednisone equivalent; local, inhaled, or intranasal use of glucocorticoids; and subjects with contrast medium allergy received prophylactic one-time use of glucocorticoids before undergoing imaging enhancement examination;\n\n  15\\. History of active autoimmune disease;\n\n  16\\. Active hepatitis B (HBe-Ag positive and HBV DNA\\>=500 IU\u002FmL), hepatitis C (HCV antibody positive and HCV RNA higher than the lower limit of assay detection)\n\n  17\\. Received any other anti-tumor treatments within 4 weeks prior to the first dose, including systemic chemotherapy, small molecule targeted therapy, radiotherapy, and Chinese herbal medicine with anti-tumor effects, except for immediate bladder instillation chemotherapy performed after TURBT ≥ 14 days before dosing; Received immune checkpoint inhibitor therapy and antibody therapy within 6 months prior to the first dose;\n\n  18\\. The study is undergoing treatment in other clinical trials or has ended until less than 4 weeks after the first administration of the study;\n\n  19\\. The presence of other 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 study results; And any other conditions that the investigator deems inappropriate for participation in this study.",{"count":50,"type":20},18,[52],"PHASE1","Phase Ia, an open-label, sequential, dose escalation study to evaluate the tolerability and safety of JL19001 Injection alone in subjects with high risk NMIBC. The investigators plan to test 3 dose levels, 100, 200, and 400 μg in the Phase Ia study. A traditional 3 + 3 dose escalation design will be used. Eligible subjects will be sequentially enrolled and will be observed for DLT(s) during the DLT monitoring period (Day 1 \\~ 21).",[55],"High Risk Non-muscle Invasive Bladder Cancer","NOT_YET_RECRUITING","2026-03-16",{"date":59,"type":33},"2026-03-19",{"date":61,"type":20},"2026-03-30",{"date":63,"type":20},"2028-03-30",{"name":65,"class":40},"Jecho Biopharmaceuticals Co., Ltd.",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100628992","phase-1-a-study-of-hs-10566-in-patients-with-high-risk-non-muscle-invasive-bladder-cancer-who-are-ineligible-for-or-refuse-radical-cystectomy-100628992","NCT07468851","A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy","A Phase I\u002FII Clinical Study Evaluating the Safety, Efficacy, Tolerability, and Pharmacokinetics of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy","Inclusion Criteria:\n\n1. Men or women aged greater than or equal to (≥) 18 years.\n2. Signed informed consent form.\n3. Histologically confirmed non-muscle-invasive bladder urothelial carcinoma (i.e., transitional cell carcinoma). Mixed tumor types predominantly consisting of urothelial carcinoma are eligible. Patients diagnosed with neuroendocrine, micropapillary, signet-ring cell, plasmacytoid, or sarcomatoid features are excluded.\n4. Patients with non-muscle-invasive bladder cancer (NMIBC) who have undergone prior transurethral resection of bladder tumor (TURBT) and who refuse or are ineligible for radical cystectomy, and meet one of the following two populations:\n\n   1. Patients with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) who are unresponsive to Bacillus Calmette-Guérin (BCG) therapy after prior TURBT, and who refuse or are ineligible for radical cystectomy. BCG unresponsive is defined as occurrence of any one of the following in NMIBC patients after adequate BCG therapy (at least 5 full dose inductions and at least 2 maintenance instillations of BCG):\n\n      * Persistent or recurrent CIS within 12 months after adequate BCG therapy, with or without recurrence of high-grade Ta or T1 tumors;\n      * Recurrence of high-grade Ta\u002FT1 tumors within 6 months after adequate BCG therapy (disease-free);\n      * Recurrence of high-grade tumors at the first assessment during maintenance therapy after adequate BCG induction.\n   2. Patients who have not received BCG therapy after prior TURBT, including the following three scenarios:\n\n      * NMIBC patients who failed intravesical chemotherapy, and who refuse or are ineligible for repeat postoperative intravesical chemotherapy or BCG instillation by the investigator.\n      * HR-NMIBC patients who have not received BCG therapy after TURBT, and who refuse or are ineligible for BCG instillation as determined by the investigator. Ineligibility for BCG includes, but is not limited to: active tuberculosis, severe hematuria, recent traumatic catheterization, symptomatic urinary tract infection, immunodeficiency or impairment (e.g., AIDS, patients receiving immunosuppressants or radiotherapy), BCG hypersensitivity, etc.\n      * HR-NMIBC patients who received prior BCG therapy but discontinued treatment for more than 3 years before enrollment.\n5. Participants must have undergone TURBT within 12 weeks prior to signing informed consent and meet the following criteria:\n\n   1. For papillary lesions (Ta and T1 stages): complete resection of all visible papillary lesions, with negative urine cytology (including atypical findings).\n   2. For patients with CIS: residual unresectable CIS lesions are permitted.\n6. Sufficient bone marrow reserve and adequate hepatic\u002Frenal function.\n7. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1.\n\nExclusion Criteria:\n\n1. Histopathologically confirmed muscle invasive (pathologic T stage ≥ T2), locally advanced, unresectable, or metastatic urothelial carcinoma.\n2. Urothelial carcinoma outside the bladder (e.g., urethra, ureter, renal pelvis) unless radically resected with no disease recurrence for \\> 2 years.\n3. History of other primary solid tumors, except:\n\n   1. Radically treated solid tumor with no activity for ≥5 years before enrollment and low recurrence risk;\n   2. adequately treated non-melanoma skin cancer (e.g., basal cell carcinoma, squamous cell carcinoma) or lentigo maligna with no evidence of recurrence;\n   3. adequately treated carcinoma in situ (e.g., cervical, ductal carcinoma in situ of breast) with no evidence of recurrence.\n4. Has received or is receiving any of the following treatments:\n\n   1. Regular intravesical chemotherapy (gemcitabine, pirarubicin, mitomycin, etc.) or BCG instillation intolerance following TURBT\u002Fbladder biopsy before enrollment.\n   2. Pelvic radiotherapy within 4 weeks prior to first study treatment. Patients with last radiotherapy \\>4 weeks prior and no confirmed radiation cystitis may be enrolled.\n   3. Major surgery (TURBT is not considered major surgery) within 4 weeks before first study treatment, or incomplete recovery from postoperative complications.\n   4. Systemic chemotherapy, small-molecule targeted therapy, or investigational therapy within 4 weeks before first study treatment.\n5. Residual toxicity ≥ Grade 2 per CTCAE version 6.0 from prior therapy (surgery, intravesical instillation, etc.), except alopecia, pigmentation.\n6. Bladder or urethral anatomical features that may interfere with HS-10566 implantation, retention, or removal (e.g., urethral stricture, bladder diverticulum, total urinary incontinence, bladder perforation).\n7. Current or history of clinically significant polyuria (24-hour urine output \\>4000 mL).\n8. Requirement for long-term indwelling urinary catheter during study treatment (e.g., urinary obstruction).\n9. Intermittent catheterization for clinical indications is allowed.",{"count":74,"type":20},180,[52,23],"This is a multicenter, open-label, Phase I\u002FII clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) profiles of HS-10566 in patients with high-risk non-muscle-invasive bladder cancer who are ineligible for or refuse radical cystectomy. The study comprises two distinct phases: a dose exploration phase and a proof-of-concept phase.",[78],"High-risk Non-muscle-invasive Bladder Cancer",[80],"High-risk Non-muscle-invasive Bladder Neoplasms Administration, Intravesical","2026-03-08",{"date":83,"type":33},"2026-03-13",{"date":85,"type":20},"2026-06-10",{"date":87,"type":20},"2029-04-30",{"name":89,"class":40},"Jiangsu Hansoh Pharmaceutical Co., Ltd.",2,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":99,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":121},"100613572","phase-3-a-phase-iii-randomised-control-clinical-trial-of-radiotherapy-with-radiosensitisation-versus-intravesical-bacillus-calmette-guerin-therapy-for-high-risk-non-muscle-invasive-bladder-cancer-100613572","NCT07268339","A Phase III Randomised Control Clinical Trial of Radiotherapy With Radiosensitisation Versus Intravesical Bacillus Calmette-Guerin Therapy for High-risk Non-muscle Invasive Bladder Cancer.","TRAIN - A Phase III Randomised Control Clinical Trial of Radiotherapy With Radiosensitisation Versus Intravesical Bacillus Calmette-Guerin Therapy for High-risk Non-muscle Invasive Bladder Cancer.","TRAIN","Inclusion Criteria:\n\n* Diagnosed with histologically confirmed grade 3 T1 N0 M0 transitional cell carcinoma, OR carcinoma in situ of the bladder (and N0 M0), OR both, with detrusor muscle present in the biopsy specimen if T1 disease (or a repeat resection that does contain muscle that is clear)\n* Suitable for BCG treatment\n* Suitable for radiotherapy and radiosensitisation according to the schedule of administration outlined in the Radiotherapy Planning Guidance document.\n* Life expectancy over 12 months\n* ECOG performance status 0 - 2\n* Age \\>=16 years\n* Provided written informed consent\n\nExclusion Criteria:\n\n* MDT selected patients with HR-NMIBC who are deemed best suited for primary cystectomy (patients that have had this treatment recommendation but then decline cystectomy remain eligible for TRAIN)\n* Previous radiotherapy to the pelvis\n* Previous intravesical therapy\n* Poor bladder function (IPSS \\>16)\n* A recent or current other cancer. Current non-melanoma skin cancer, cervical carcinoma in situ or localized prostate cancer not requiring current treatment are permissible, as is a history of a separate other malignancy having completed all active treatment ≥2 years previously and without evidence of relapse\n* Pre-existing medical conditions that preclude treatment options in either trial arm\n* Patient currently recruited to another interventional trial or participation within an interventional clinical trial within 3 months of the point of registration within TRAIN.\n* Pregnant or breast-feeding\n* Not able to use appropriate adequate effective contraception during and for 3 months after the study","16 Years",{"count":101,"type":20},328,[103],"PHASE3","In the UK 20,000 people develop urothelial bladder cancer each year with 75-80% having Non-Muscle Invasive Bladder Cancer (NMIBC). The current standard of care for patients with High Risk-NMIBC (HR-NMIBC) is either surgery to remove the tumour (transurethral resection of bladder tumour; TURBT) followed by BCG (Bacillus Calmette Guérin, an immunotherapy drug) given directly into the bladder, or surgery to remove the bladder (cystectomy). BCG is given weekly for six weeks followed by maintenance treatment up to 3 years. However, in up to 50% of patients their cancer returns (recurrence) or gets worse (progression) after BCG and 25% stop treatment due to side effects. Globally BCG supply has been restricted in recent years has increased HR-NMIBC recurrence rates and costs. Improved treatments are required, to prevent recurrence, progression and cystectomy, and mitigate the effects of unpredictable supply.\n\nTrimodality treatment (TMT) is maximal TURBT + radiotherapy + a radiosensitiser (gemcitabine, mitomycin C\u002Ffluorouracil or carbogen\u002Fnicotinamide) and is an equivalent alternative treatment to cystectomy for muscle-invasive bladder cancer (MIBC). TMT is not routinely used for HR-NMIBC. A study found that 54% of HR-NMIBC patients who received TMT did not have recurrence within 5 years. Modern radiotherapy is expected to further improve outcomes and minimise side-effects.\n\nPatients will be randomised 1:1 to BCG or radiotherapy with radiosensitisation. Patients randomised to the experimental arm will receive 55Gy in 20 fractions. Investigators can then choose from three different options for the radiosensitiser. TRAIN will test if radiotherapy with radiosensitisation improves outcomes for people with HR-NMIBC compared to BCG.\n\nTRAIN will recruit 328 patients with HR-NMIBC following maximal TURBT. All patients will be followed up for a minimum of two years to record their response to treatment.",[106],"High-Risk Non-Muscle Invasive Bladder Cancer",[108,109,110],"non-muscle invasive bladder cancer","radiotherapy with radiosensitisation drugs","Bacillus Calmette-Guerin therapy","2025-11-25",{"date":113,"type":33},"2025-12-05",{"date":115,"type":20},"2025-12-01",{"date":117,"type":20},"2031-12-01",{"name":119,"class":120},"The Christie NHS Foundation Trust","OTHER",1,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"100545157","phase-1-to-evaluate-the-safety-efficacy-and-pharmacokinetics-of-intravesical-instiliations-of-disitamab-vedotin-in-patients-with-high-risk-non-muscular-invasive-bladder-cancer-nmibc-that-express-her2-100545157","NCT06378242","To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2","An Single-arm, Multicenter Phase I\u002FII Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2","Inclusion Criteria:\n\n1. Voluntary consent to participate in the study and signed the informed consent form.\n2. Male or female, age 18-75 years (including both).\n3. Histologic confirmed non-muscle invasive bladder urothelial carcinoma (NMIBC), and the risk group met the high-risk (including very high-risk) group.\n\n   Note: High-risk NMIBC is a high-grade \u002F G3 tumor meeting any of the following:\n\n   a.Carcinoma in situ (CIS) b. T1 stage c. diameter\\>3cm d.Multiple tumors, or recurrent tumors.\n4. Absence of resectable disease（Ta and\u002For T1 disease） after transurethral resection (TURBT) procedures (residual CIS acceptable;\n5. The urologist assessed that radical surgery for bladder cancer was not suitable or the subject refused radical surgery for bladder cancer.\n6. Tumor tissue samples were detected by immunohistochemistry (IHC) to satisfy HER2 expression of 1+, 2+ or 3+.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n8. Adequate heart, bone marrow, liver, kidney and coagulation function\n\nExclusion Criteria:\n\n* 1\\. Invasive bladder cancer (T2 and above) and \u002F or with regional lymph node and distant metastasis.\n\n  2\\. Combined urothelial carcinoma outside the bladder (i. e., urethra, ureter or renal pelvis).\n\n  3\\. Any other antitumor therapy received within 4 weeks before study administration, .\n\n  4 Subjects plan to undergo major surgery during the study or within 4 weeks before the first dose.\n\n  5, Known allergic to DV and its components or to any excipients.","75 Years",{"count":131,"type":20},24,[52,23],"The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2",[135],"High-risk Non-muscle Invasive Bladder Cancer",[137,138,139],"HER2-expression","High-risk non-muscle invasive bladder cancer","intravesical instiliations","2024-07-09",{"date":142,"type":33},"2024-07-11",{"date":144,"type":33},"2024-06-14",{"date":146,"type":20},"2029-12-31",{"name":148,"class":40},"RemeGen Co., Ltd.",6]