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Heated chemo offers new hope for bladder cancer patients facing surgery

NCT ID NCT07231809

Disease control Sponsor: AC.TA. S.r.l. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a treatment called HIVEC, which delivers heated chemotherapy directly into the bladder. It is for people with a type of bladder cancer that has not responded to standard therapy and who cannot have their bladder removed. The goal is to see if this approach is safe and can keep the cancer from coming back for at least 12 months. About 50 people will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

bladder carcinoma in situ bladder transitional cell carcinoma carcinoma non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma urinary bladder carcinoma urinary bladder neoplasm Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BCG non responsive nmibc Bladder cancer Carcinoma in situ of bladder Carcinoma in situ of the bladder Carcinoma, transitional cell, bladder High grade nmibc Non-muscle invasive bladder cancer Urinary bladder neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • P.O. "Santa Maria delle Grazie" - ASL Napoli 2 Nord

    Pozzuoli, 80078, Italy

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