Hyperthermic Intravesical Chemotherapy (HIVEC) in BCG-Non-Responsive High-Grade NMIBC Patients

Sponsor
AC.TA. S.r.l.
Study ID
NCT07231809
Status
Not Yet Recruiting

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Conditions

  • Bladder Cancer
  • Carcinoma in Situ of Bladder
  • Carcinoma, Transitional Cell, Bladder
  • Non Muscle Invasive Bladder Cancer
  • Urinary Bladder Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hyperthermic Intravesical Chemotherapy (HIVEC) — PROCEDURE
    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.

Study Details

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 Dates

First listed
Nov 17, 2025
Start date
Oct 15, 2026
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HIVEC Treatment Arm
    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.

Primary Outcome Measure

Treatment-Related Adverse Events (AEs) [ Time Frame: Up to 12 months ]

Central Contacts

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