[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642575":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":28,"locations":41,"responsibleParty":61,"collaborators":63,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":28,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":28,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":43,"whyStopped":28,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Peking University Third Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Enfortumab Vedotin + Toripalimab","EXPERIMENTAL","Participants in this arm will receive neoadjuvant therapy consisting of Enfortumab Vedotin and Toripalimab. Enfortumab Vedotin (1.25 mg\u002Fkg) will be administered intravenously on Days 1 and 8 of each 21-day cycle. Toripalimab (240 mg) will be administered intravenously on Day 1 of each 21-day cycle. The treatment will be administered for a total of 3 cycles, followed by radical cystectomy and pelvic lymph node dissection.",[13,14],"Drug: enfortumab vedotin (EV)","Drug: Toripalimab",{"label":16,"type":17,"description":18,"interventionNames":19},"Active Comparator: Gemcitabine + Cisplatin","ACTIVE_COMPARATOR","Participants in this arm will receive standard neoadjuvant chemotherapy consisting of Gemcitabine and Cisplatin. Gemcitabine (1000 mg\u002Fm\\^2) will be administered intravenously on Days 1 and 8 of each 21-day cycle. Cisplatin (70 mg\u002Fm\\^2) will be administered intravenously on Day 1 of each 21-day cycle. The treatment will be administered for a total of 3 cycles, followed by radical cystectomy and pelvic lymph node dissection.",[20,21],"Drug: Gemcitabine (Chemotherapy)","Drug: Cisplatin",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","enfortumab vedotin (EV)","Enfortumab Vedotin is administered intravenously at a dose of 1.25 mg\u002Fkg on Day 1 and Day 8 of each 21-day cycle for a total of 3 cycles",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Toripalimab","Toripalimab is administered intravenously at a dose of 240 mg on Day 1 of each 21-day cycle for a total of 3 cycles.",[9],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Gemcitabine (Chemotherapy)","Gemcitabine is administered intravenously at a dose of 1000 mg\u002Fm² on Day 1 and Day 8 of each 21-day cycle for a total of 3 cycles.",[16],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Cisplatin","Cisplatin is administered intravenously at a dose of 70 mg\u002Fm² on Day 1 of each 21-day cycle for a total of 3 cycles.",[16],[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Beijing","Beijing Municipality","100191","China","CN",{"type":50,"coordinates":51},"Point",[52,53],116.39723,39.9075,{"lat":53,"lon":52},[56],{"name":57,"role":58,"phone":59,"phoneExt":28,"email":60},"Clinical Trial Office","CONTACT","+86 10 8226 5573","bysy@bjmu.edu.cn",{"type":62,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[64,66],{"name":65,"class":6},"Jiangsu Provincial People's Hospital",{"name":67,"class":6},"Peking University Cancer Hospital & Institute","100642575","phase-2-ev--toripalimab-vs-gc-as-neoadjuvant-therapy-in-locally-advancedhigh-risk-mibc-100642575",false,"NCT07647289","EV + Toripalimab vs GC as Neoadjuvant Therapy in Locally Advanced\u002FHigh-Risk MIBC","A Phase II, Two-arm, Open-label, Multicenter, Randomized Controlled Clinical Study Evaluating the Safety and Efficacy of Enfortumab Vedotin Combined With Toripalimab Versus Gemcitabine Combined With Cisplatin in the Neoadjuvant Treatment of Patients With Locally Advanced\u002FHigh-risk Muscle-invasive Bladder Cancer","Inclusion Criteria:\n\n* Voluntarily agree to participate in the study and sign the informed consent form (ICF).\n* Age ≥ 18 and ≤ 80 years at the time of signing the ICF.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically confirmed muscle-invasive urothelial carcinoma of the bladder, with variant histology components comprising \\\u003C 50%.\n* Radiographically confirmed non-metastatic urothelial carcinoma (M0). Clinical stage must be locally advanced or possess high-risk features, including at least one of the following: clinical stage cT3-T4aNxM0, or definitive high-risk cT2 (e.g., accompanied by tumor-related hydronephrosis, lymphovascular invasion).\n* Participants must be evaluated as fit for and scheduled to undergo radical surgery, and clinically fit to tolerate cisplatin-based chemotherapy.\n* Able to provide tumor tissue samples (at least 5 unstained slides, or paraffin scrolls\u002Fblocks).\n* Expected life expectancy of at least 12 weeks.\n* Adequate organ function, defined by the following laboratory values (obtained without blood transfusion within 14 days or growth factor support within 7 days prior to testing): Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL; Platelet count (PLT) ≥ 100 × 10\\^9\u002FL; Hemoglobin (Hb) ≥ 90 g\u002FL; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × Upper Limit of Normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; International Normalized Ratio (INR) ≤ 1.5 × ULN; Creatinine clearance ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula); Left ventricular ejection fraction (LVEF) ≥ 50%; QTcF interval ≤ 480 ms.\n* Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment and must be willing to use highly effective contraception during the study and for 180 days after the last dose.\n* Male participants with female partners of childbearing potential must be surgically sterile or willing to use highly effective contraception during the study and for 180 days after the last dose.\n* Able to understand and comply with study visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* Prior systemic anti-tumor therapy for urothelial carcinoma, including radiotherapy, chemotherapy, targeted therapy, or biological therapy (except for intravesical instillation therapy).\n* Prior treatment with PD-1\u002FPD-L1 inhibitors or antibody-drug conjugates (ADCs).\n* Active malignancies other than urothelial carcinoma within 3 years prior to the first dose, except for curatively treated malignancies (e.g., basal or squamous cell skin cancer, localized low-risk prostate cancer, papillary thyroid cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast).\n* Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose; or received high-dose steroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose. (Physiological replacement therapies are permitted).\n* Severe thromboembolic events or severe cardiovascular\u002Fcerebrovascular diseases within 1 year prior to the first dose, including but not limited to myocardial infarction, unstable angina, pulmonary embolism, cerebral hemorrhage, cerebral infarction, and deep vein thrombosis.\n* Major surgical procedure within 28 days prior to the first dose; or cystoscopy\u002Fureteroscopy biopsy or intravesical therapy within 7 days prior to the first dose.\n* Peripheral neuropathy ≥ Grade 2.\n* Severe dry eye syndrome, active keratitis, corneal ulcers, or conditions assessed by the investigator as increasing the risk of corneal disease and unsuitable for participation.\n* Active infections, including: Positive HBsAg with HBV-DNA copy number ≥ 500 IU\u002FmL; Positive HCV antibody with positive HCV-RNA; Positive HIV antibody; Active tuberculosis infection; Other active infections requiring systemic therapy within 7 days prior to the first dose.\n* Other severe or uncontrolled diseases, including but not limited to: Severe respiratory diseases (e.g., moderate-to-severe interstitial or obstructive pulmonary disease, severe asthma); New York Heart Association (NYHA) Class III or IV heart failure; HbA1c ≥ 8% (except for participants whose fasting blood glucose is stably controlled at ≤ 10 mmol\u002FL with medication); Poorly controlled hypertension (systolic BP ≥ 160 mmHg and\u002For diastolic BP ≥ 100 mmHg); Large pleural effusion or ascites requiring symptomatic treatment within 14 days prior to the first dose.\n* Receipt of live vaccines within 28 days prior to the first dose or plans to receive live vaccines during the study.\n* Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.\n* Use of strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose.\n* Known severe hypersensitivity or intolerance to the study drugs or any of their excipients.\n* Substance abuse or psychiatric disorders that may interfere with study compliance.\n* Any other condition that, in the opinion of the investigator, makes the participant unsuitable for the study.","ALL","18 Years","80 Years",{"count":79,"type":80},58,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","The purpose of this Phase II, open-label, multicenter, randomized controlled study is to evaluate the efficacy and safety of Enfortumab Vedotin in combination with Toripalimab compared to Gemcitabine plus Cisplatin. This regimen is evaluated as a neoadjuvant treatment for patients with locally advanced or high-risk muscle-invasive bladder cancer. Participants will be randomly assigned in a 1:1 ratio to one of two cohorts. Cohort A will receive Enfortumab Vedotin and Toripalimab for 3 treatment cycles. Cohort B will receive Gemcitabine and Cisplatin for 3 treatment cycles. Following the neoadjuvant treatment phase, patients will undergo radical cystectomy and pelvic lymph node dissection. The primary endpoint of the study is the 1-year Event-Free Survival (EFS) rate. Secondary endpoints include pathological downstaging rate (pDR), pathological complete response (pCR), Disease-Free Survival (DFS), Overall Survival (OS), and the assessment of adverse events. Additionally, the study will evaluate the relationship between treatment efficacy and the expression of PD-L1 and Nectin-4 in tumor tissues.",[86],"Muscle-Invasive Bladder Cancer (MIBC)",[88,89,90,30,91,92,93],"MIBC","Neoadjuvant Therapy","Enfortumab Vedotin","Antibody-Drug Conjugates","Nectin-4","Urothelial Carcinoma","2026-06-09",{"date":96,"type":97},"2026-06-15","ACTUAL",{"date":99,"type":97},"2025-04-15",{"date":101,"type":80},"2028-12",{"name":5,"class":6},1]