New injection method aims to stop bladder cancer from returning
NCT ID NCT07198451
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether injecting the chemotherapy drug gemcitabine directly into the bladder wall can prevent cancer from coming back in people with intermediate- or high-risk non-muscle-invasive bladder cancer. About 320 participants will receive either the new injection or the standard treatment (a liquid instilled into the bladder). The goal is to see if the new method lowers the chance of recurrence over two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gemcitabine
- What this could lead to
- If it works, this could offer a more effective way to prevent bladder cancer from coming back, potentially reducing the need for repeated surgeries or stronger treatments.
- What could go wrong
- This is an early-phase trial (Phase 2/3) with only 320 participants, so results may not apply to everyone. The injection method is new and could have unknown risks or side effects.
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 320 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. Patients aged 18 to 80 years (inclusive) with radiologically confirmed bladder tumor and scheduled to undergo transurethral resection of bladder tumor (TURBT). 2. Postoperative pathological confirmation of intermediate- or high-risk non-muscle-invasive bladder cancer (NMIBC). 3. Voluntarily participate in the study and sign the informed consent form, ensuring the patient fully understands the trial purpose, risks, and right to withdraw. Exclusion Criteria: 1. Preoperative comorbidities including detrusor overactivity, urethral stricture, urge incontinence, stress incontinence, or overflow incontinence. 2. Concurrent urogenital infectious diseases (e.g., acute urethritis, acute cystitis). 3. History of pelvic radiotherapy. 4. Receiving systemic anti-tumor therapy for any malignant tumor. 5. Severe cardiovascular disease, hepatic or renal insufficiency, or coagulation dysfunction. 6. Presence of mental illness or psychological disorders that impair normal communication. 7. Any other situation deemed by the investigator as unsuitable for participation in this clinical study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Timing chemotherapy around bladder surgery may cut recurrence
- Can a glowing dye reveal hidden bladder cancer during surgery?
- Can a chemo gel spare the bladder in cancer?
- AI reads tumor images to forecast bladder cancer treatment response