[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AC.TA. S.r.l.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":50},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100610763","hyperthermic-intravesical-chemotherapy-hivec-in-bcg-non-responsive-high-grade-nmibc-patients-100610763",false,"NCT07231809","Hyperthermic Intravesical Chemotherapy (HIVEC) in BCG-Non-Responsive High-Grade NMIBC Patients","Hyperthermic Intravesical Chemotherapy (HIVEC) In Patients With BCG-Non Responsive Or Intolerant High-Grade BCG-Infiltrating Non-Muscle-Infiltrating Bladder Cancer And Not Eligible For Radical Cystectomy: Phase II Study (SMG-Bladder 01).","HIVEC","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed high-grade non-muscle-invasive bladder cancer (NMIBC), including Ta, T1, and\u002For carcinoma in situ (CIS).\n* BCG-unresponsive or BCG-intolerant disease according to international definitions (persistent or recurrent high-grade NMIBC after adequate BCG therapy).\n* Patient is ineligible for, or refuses, radical cystectomy.\n* Candidate for hyperthermic intravesical chemotherapy (HIVEC) according to clinical judgment.\n* ECOG Performance Status 0-2.\n* Adequate organ function according to institutional standards.\n* Ability and willingness to comply with study procedures and follow-up schedule.\n* Written informed consent obtained.\n\nExclusion Criteria:\n\n* Muscle-invasive bladder cancer (≥ T2) or metastatic disease.\n* Active urinary tract infection at baseline.\n* Previous treatment with HIVEC or other intravesical hyperthermia systems.\n* Known hypersensitivity to Mitomycin C or contraindications to intravesical chemotherapy.\n* Active uncontrolled bleeding or gross hematuria preventing intravesical instillation.\n* Upper urinary tract urothelial carcinoma.\n* Pregnant or breastfeeding women.\n* Any medical or psychological condition that, in the investigator's judgment, could interfere with study participation or compromise patient safety.","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a Phase II, prospective, single-arm, open-label clinical study evaluating hyperthermic intravesical chemotherapy (HIVEC) with Mitomycin C in patients with high-grade, non-muscle-invasive bladder cancer (NMIBC) who are BCG-non-responsive or BCG-intolerant and are ineligible for, or refuse, radical cystectomy. Mitomycin C is an approved medicinal product used within routine clinical practice and administered with a CE-marked recirculation device (BRS Combat system) that maintains the solution at approximately 43°C for 60 minutes. The treatment schedule consists of 6 weekly induction instillations followed by 9 monthly maintenance instillations.\n\nThe co-primary objectives are to describe the safety and toxicity profile of HIVEC, including treatment discontinuations due to procedure-related toxicity, and to estimate the 12-month recurrence-free survival (12moRFS). Secondary objectives include characterizing patterns of non-muscle-invasive and muscle-invasive recurrences, bladder cancer-specific survival, overall survival, and quality of life. Approximately 50 patients will be enrolled in this single-center pilot study to generate exploratory safety and efficacy data in this high-risk population and to support the design of future randomized trials",[27,28,29,30,31],"Non Muscle Invasive Bladder Cancer","Bladder Cancer","Carcinoma in Situ of Bladder","Urinary Bladder Neoplasms","Carcinoma, Transitional Cell, Bladder",[15,33,34,35,36,37],"Hyperthermic Intravesical Chemotherapy","Mitomycin C","BRS Combat System","Bladder Tumor Recurrence","High-Grade Bladder Cancer","NOT_YET_RECRUITING","2026-05-04",{"date":41,"type":42},"2026-05-06","ACTUAL",{"date":44,"type":21},"2026-10-15",{"date":46,"type":21},"2028-05-31",{"name":48,"class":49},"AC.TA. S.r.l.","INDUSTRY",""]