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Can a Two-Drug bladder wash beat cancer recurrence?

NCT ID NCT07747740

Disease control Sponsor: Blokhin's Russian Cancer Research Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests two different drug combinations given directly into the bladder for people with a type of bladder cancer that has not responded to the standard BCG therapy. Participants are randomly assigned to receive either gemcitabine plus docetaxel or gemcitabine plus mitomycin C. The goal is to see which combination better prevents the cancer from coming back or progressing over a year, while also checking safety and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sequential intravesical gemcitabine plus docetaxel, compared with sequential intravesical gemcitabine plus mitomycin C
What this could lead to
If successful, this could offer a bladder-sparing alternative to cystectomy for patients with BCG-unresponsive bladder cancer, potentially improving survival and quality of life.
What could go wrong
This is a phase II trial, so results are preliminary. The treatments may not prove more effective than existing options, and there are risks of side effects from chemotherapy delivered directly into the bladder.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 228 people

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

Started

Jul 2026

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: 1. Age ≥18 years. 2. Histologically confirmed BCG-unresponsive non-muscle-invasive urothelial bladder cancer (NMIBC). 3. Complete transurethral resection of bladder tumor (TURBT) before study treatment. 4. Intermediate- or high-risk NMIBC according to current clinical guidelines. 5. Candidate for intravesical chemotherapy. 6. ECOG performance status 0-2. 7. Adequate hematologic, renal, and hepatic function. 8. Written informed consent. Exclusion Criteria: 1. Muscle-invasive (≥T2), locally advanced, or metastatic urothelial carcinoma. 2. Upper urinary tract urothelial carcinoma requiring treatment. 3. Previous hypersensitivity to gemcitabine, docetaxel, mitomycin C, or formulation components. 4. Active uncontrolled urinary tract infection. 5. Pregnancy or breastfeeding. 6. Concurrent participation in another interventional clinical trial. 7. Any serious uncontrolled medical condition that, in the investigator's opinion, would interfere with study participation or interpretation of results.

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Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms

As listed by the trial registrant

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

BCG-unresponsive bladder cancer Non-muscle invasive bladder cancer

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

  • N.N. Blokhin National Medical Research Center of Oncology

    RECRUITING

    Moscow, Moscow, 115522, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.