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New gel could zap kidney cancer without surgery

NCT ID NCT06124976

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This study tests a gel form of the chemotherapy drug gemcitabine, called ST-02, for people with low-grade cancer in the upper urinary tract. The gel is placed directly into the kidney through a small tube. The goal is to see if it can destroy tumors within three months and remain safe. About 70 adults with small, low-grade tumors will receive six weekly treatments.

What this could mean

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

Active substance
ST-02 (mucoadhesive gemcitabine suspension)
What this could lead to
If it works, this could offer a less invasive way to treat low-grade upper urinary tract cancer, potentially avoiding surgery.
What could go wrong
This is an early-phase trial with only 70 participants. The treatment may not fully eliminate tumors, and side effects from the chemotherapy gel are possible.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 70 people

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

Started

Jun 2024

Expected to finish

Jun 2028

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: * Adult (≥ 18 years) male or female * Primary or recurrent low-grade (LG), noninvasive (Ta) Upper Tract Urothelial Carcinoma (UTUC) in the renal pelvis, infundibulum, and/or calyces, based on ureteroscopy, biopsy and cytology (disease assessment URS) performed within 8 weeks prior to or during the Screening Visit * At least 1 measurable papillary tumor measuring 5-15 mm * Low grade tumor(s) in the ipsilateral ureter. Every attempt should be made to ablate this tumor completely, but residual ipsilateral ureteral tumor is not an exclusion criterion. * Prior fully ablated low grade bladder tumor(s), without the need for intravesical therapy except for single-dose chemotherapy * A life expectancy of greater than 12 months * No active untreated urinary tract infection (UTI) as confirmed by urine culture or urinalysis * Women of Child bearing potential (WoCBP) and Males who have a WoCBP partner require a negative pregnancy test at the Screening visit and must use two acceptable contraceptives methods until six months post-treatment * All sexually active males must agree to use a condom during intercourse, for at least 48 h after each instillation * eGFR ≥10 mL/min; weekly creatinine monitoring recommended during treatment for participants with eGFR \<30 mL/min or a solitary functional kidney Exclusion Criteria: * Have received Bacillus Calmette - Guerin (BCG) treatment for UTUC within 6 weeks prior to Visit 1 (D1) * Pregnant (positive urine pregnancy test), planning pregnancy during trial, breast-feeding, or of childbearing potential without reliable contraception * Unresolved infection requiring active treatment with systemic antimicrobial drugs * History of high-grade non-muscle invasive bladder cancer within the past 6 months * History of muscle-invasive bladder cancer during the past 2 years * Actively being treated or intend to be treated with intravesical or systemic chemotherapy during the duration of the trial * Urinary obstruction in the ipsilateral Upper Urinary Tract (UUT) * Any contraindicated to gemcitabine or sensitivity to gemcitabine or any of the ST-02 ingredients * Currently receiving another investigational agent or involved in a clinical trial with an investigational product within the past 30 days prior to Visit 1 (D1) * Active hepatitis B (chronic or acute) or active hepatitis C infection

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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    8 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    NOT_YET_RECRUITING

    Montreal, Quebec, Canada

  • Centre de recherche du CHUS

    NOT_YET_RECRUITING

    Sherbrooke, Quebec, Canada

  • Centre of Applied Urology Research, Nova Scotia Health Authority

    RECRUITING

    Halifax, Nova Scotia, Canada

  • London Health Sciences Centre - Victoria Hospital

    RECRUITING

    London, Ontario, Canada

  • McGill University Health Center

    RECRUITING

    Montreal, Quebec, Canada

  • Men's Health Clinic

    RECRUITING

    Winnipeg, Manitoba, Canada

    Contact Email: •••••@•••••

  • UHN - Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, Canada

  • Vancouver Prostate Centre

    RECRUITING

    Vancouver, British Columbia, Canada

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