Hyperthermic Intravesical Chemotherapy (HIVEC) in BCG-Non-Responsive High-Grade NMIBC Patients
Starting soon · Not applicable
Conditions studied: Non Muscle Invasive Bladder Cancer, Bladder Cancer, Carcinoma in Situ of Bladder, Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Bladder
In brief
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
Key facts
- Study ID
- NCT07231809
- Run by
- AC.TA. S.r.l.
- People needed
- 50
- Starts
- 2026-10-15
- Expected to finish
- 2028-05-31
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Candidate for hyperthermic intravesical chemotherapy (HIVEC) according to clinical judgment.
- ECOG Performance Status 0-2.
- Adequate organ function according to institutional standards.
- Ability and willingness to comply with study procedures and follow-up schedule.
- Written informed consent obtained.
You may not qualify if…
- 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.
- Active uncontrolled bleeding or gross hematuria preventing intravesical instillation.
- Upper urinary tract urothelial carcinoma.
- Pregnant or breastfeeding women.
- Any medical or psychological condition that, in the investigator's judgment, could interfere with study participation or compromise patient safety.
Where it is running
- P.O. "Santa Maria delle Grazie" - ASL Napoli 2 Nord — Pozzuoli, Italy
Full record on ClinicalTrials.gov
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