[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610763":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":28,"locations":38,"responsibleParty":53,"collaborators":32,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":32,"enrollmentInfo":65,"targetDuration":32,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":78,"overallStatus":84,"whyStopped":32,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"AC.TA. S.r.l.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HIVEC Treatment Arm","EXPERIMENTAL","Participants will receive Hyperthermic Intravesical Chemotherapy (HIVEC) with Mitomycin C according to the study protocol (induction + maintenance schedule). Mitomycin C is an approved medicinal product used within routine clinical practice. HIVEC is performed using a CE-marked recirculation system that maintains the solution at a controlled therapeutic temperature.",[13],"Procedure: Hyperthermic Intravesical Chemotherapy (HIVEC)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Hyperthermic Intravesical Chemotherapy (HIVEC)","Intravesical administration of Mitomycin C heated to approximately 43°C using a CE-marked recirculation system (BRS Combat device). Mitomycin C is supplied by the treating hospital as part of routine clinical practice. The procedure consists of 6 weekly instillations followed by 9 monthly instillations.",[9],[21,22],"HIVEC System","BRS Combat",[24],{"name":25,"affiliation":26,"role":27},"Gaetano Facchini, MD","P.O. \"Santa Maria delle Grazie\" - ASL Napoli 2 Nord","PRINCIPAL_INVESTIGATOR",[29,34],{"name":25,"role":30,"phone":31,"phoneExt":32,"email":33},"CONTACT","+3908118844043",null,"gaetano.facchini@aslnapoli2nord.it",{"name":35,"role":30,"phone":36,"phoneExt":32,"email":37},"Alessandra Marabese, Perfusionist","+393388355145","alessandra.marabese@actagroup.eu",[39],{"facility":26,"status":32,"city":40,"state":32,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Pozzuoli","80078","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],14.0952,40.84394,{"lat":48,"lon":47},[51,52],{"name":25,"role":30,"phone":31,"phoneExt":32,"email":33},{"name":25,"role":27,"phone":32,"phoneExt":32,"email":32},{"type":54,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","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":66,"type":67},50,"ESTIMATED","INTERVENTIONAL",[70],"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",[73,74,75,76,77],"Non Muscle Invasive Bladder Cancer","Bladder Cancer","Carcinoma in Situ of Bladder","Urinary Bladder Neoplasms","Carcinoma, Transitional Cell, Bladder",[61,79,80,81,82,83],"Hyperthermic Intravesical Chemotherapy","Mitomycin C","BRS Combat System","Bladder Tumor Recurrence","High-Grade Bladder Cancer","NOT_YET_RECRUITING","2026-05-04",{"date":87,"type":88},"2026-05-06","ACTUAL",{"date":90,"type":67},"2026-10-15",{"date":92,"type":67},"2028-05-31",{"name":5,"class":6},1]