Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
The goal of this prospective clinical trial is to investigate the safety and efficacy of ST-02 (mucoadhesive gemcitabine suspension for pyelocaliceal instillation) to treat Upper Tract Urothelial Carcinoma (UTUC) in participants who have a low-grade tumor. The main questions this study aims to answer are: 1. Can ST-02 effectively eradicate UTUC by 3 months? 2. Is ST-02 safe for patients with UTUC? Participants in this study will receive ST-02, a new formulation with gemcitabine once weekly for six weeks. Gemcitabine is known to be an effective drug in treating urothelial carcinoma. This new formulation will be instilled directly into the upper urinary tract (renal pelvis) and will allow the chemotherapeutic to work locally for an extended period of time. The administration process will be retrograde (via a small catheter inserted up into the kidney, under anesthesia) or antegrade (via a nephrostomy, in the clinic) once weekly for six weeks. Safety and efficacy will be monitored for up to a year after the initial response assessment.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pełnoletni pacjent (18 lat lub więcej)
- •Nowotwór niskiego stopnia zaawansowania w miednicy nerkowej lub kielichach nerki, potwierdzony badaniem w ciągu 8 tygodni
- •Guz o rozmiarze 5-15 mm widoczny na badaniu
- •Przewidywana długość życia ponad 12 miesięcy
- •Brak aktualnego zapalenia dróg moczowych
- •Przy pracy nerek: przepuszczalność kłębuszkowa co najmniej 10 mL/min
- •Kobiety mogące zajść w ciążę muszą stosować dwie metody antykoncepcji przez 6 miesięcy po leczeniu
- •Mężczyźni muszą używać prezerwatywy przez 48 godzin po każdym zastrzyku leku
✗ Disqualifies
- •Otrzymanie leczenia BCG w ciągu ostatnich 6 tygodni
- •Ciąża, karmienie piersią lub planowanie ciąży
- •Nieleczymy aktywne zapalenie wymagające antybiotyków
- •Rak wysokiego stopnia zaawansowania pęcherza w ostatnich 6 miesiącach
- •Rak mięśni pęcherza w ostatnich 2 latach
- •Jednoczesne leczenie chemioterapią
- •Niedrożność dróg moczowych
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 3, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (8)
Vancouver Prostate Centre
Vancouver, Canada
Men's Health Clinic
Winnipeg, Canada
Centre of Applied Urology Research, Nova Scotia Health Authority
Halifax, Canada
London Health Sciences Centre - Victoria Hospital
London, Canada
UHN - Princess Margaret Cancer Centre
Toronto, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Canada
McGill University Health Center
Montreal, Canada
Centre de recherche du CHUS
Sherbrooke, Canada
Trial contact
Dasa Durkotova
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/4/2026.
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