New gel could zap kidney cancer without surgery
NCT ID NCT06124976
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
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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 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- 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 years and older
- 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: * 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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Genom att skicka in godkänner du våra Användarvillkor
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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
8 sites. The list below names each one and where it is.
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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.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
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Centre Hospitalier de l'Université de Montréal (CHUM)
NOT_YET_RECRUITINGMontreal, Quebec, Canada
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Centre de recherche du CHUS
NOT_YET_RECRUITINGSherbrooke, Quebec, Canada
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Centre of Applied Urology Research, Nova Scotia Health Authority
RECRUITINGHalifax, Nova Scotia, Canada
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London Health Sciences Centre - Victoria Hospital
RECRUITINGLondon, Ontario, Canada
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McGill University Health Center
RECRUITINGMontreal, Quebec, Canada
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Men's Health Clinic
RECRUITINGWinnipeg, Manitoba, Canada
Contact Email: •••••@•••••
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UHN - Princess Margaret Cancer Centre
RECRUITINGToronto, Ontario, Canada
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Vancouver Prostate Centre
RECRUITINGVancouver, British Columbia, Canada
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