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.
The 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
Age ≥ 18 years.
Histologically confirmed high-grade non-muscle-invasive bladder cancer (NMIBC), including Ta, T1, and/or carcinoma in situ (CIS).
BCG-unresponsive or BCG-intolerant disease according to international definitions (persistent or recurrent high-grade NMIBC after adequate BCG therapy).
Patient is ineligible for, or refuses, radical cystectomy.
Muscle-invasive bladder cancer (≥ T2) or metastatic disease.
Active urinary tract infection at baseline.
Previous treatment with HIVEC or other intravesical hyperthermia systems.
Known hypersensitivity to Mitomycin C or contraindications to intravesical chemotherapy.
Single group
Hyperthermic Intravesical Chemotherapy (HIVEC)
Procedure/SurgeryIntravesical 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.
Treatment-Related Adverse Events (AEs)
Incidence, type, timing, and severity of adverse events graded according to NCI CTCAE v5.0. Includes local and systemic toxicities related to hyperthermic intravesical chemotherapy and the proportion of patients who discontinue treatment due to toxicity.
12-Month Recurrence-Free Survival (RFS)
Proportion of patients who remain free from histologically confirmed recurrence of non-muscle-invasive bladder cancer (Ta, T1, or CIS) at 12 months from initiation of HIVEC treatment. Recurrence is defined per standard cystoscopic and histological criteria.
Rate of non-muscle-invasive (Ta-T1) bladder cancer recurrences
Percentage of patients experiencing a histologically confirmed Ta or T1 recurrence during the 12-month follow-up period.
Rate of muscle-invasive (≥T2) recurrences
Percentage of patients who progress to muscle-invasive bladder cancer (≥T2) confirmed by imaging or histology.
Cancer-specific survival
Assessing cancer-specific survival (bladder)
Overall Survival (OS)
Time from first HIVEC instillation to death from any cause.
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