NCT07231809Not yet recruiting
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).
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- 15 Oct 2026
- Primary completion date
- 31 May 2028
- Lead sponsor
- AC.TA. S.r.l.
- Diseases
- Bladder cancer
- NCT number
- NCT07231809
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 15 Oct 2026 to the primary completion date, 31 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with HIVEC or other intravesical hyperthermia systems.
Other illness
- Muscle-invasive bladder cancer (≥ T2) or metastatic disease.
- Active urinary tract infection at baseline.
- Known hypersensitivity to Mitomycin C or contraindications to intravesical chemotherapy.
- Active uncontrolled bleeding or gross hematuria preventing intravesical instillation.
- Any medical or psychological condition that, in the investigator's judgment, could interfere with study participation or compromise patient safety.
Other
- Upper urinary tract urothelial carcinoma.
- Pregnant or breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| P.O. "Santa Maria delle Grazie" - ASL Napoli 2 Nord Coordinator of this site? Confirm its status | Pozzuoli | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.