Actively Recruiting
Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma
Led by University of British Columbia · Updated on 2025-09-15
70
Participants Needed
4
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older, male or female
- Diagnosed with primary or recurrent low-grade, noninvasive upper tract urothelial carcinoma in the renal pelvis, infundibulum, or calyces
- Have at least one measurable papillary tumor between 5 and 15 mm
- Low-grade tumor(s) present in the same side ureter; attempts to fully ablate are made but residual tumor is allowed
- Prior fully ablated low-grade bladder tumors without need for intravesical therapy except single-dose chemotherapy
- Life expectancy greater than 12 months
- No active untreated urinary tract infection confirmed by urine tests
- Women of childbearing potential and males with partners of childbearing potential must have negative pregnancy test at screening and use two contraceptive methods until six months post-treatment
- Sexually active males must use condoms for at least 48 hours after each instillation
You will not qualify if you...
- Received Bacillus Calmette - Guerin (BCG) treatment for upper tract urothelial carcinoma within 6 weeks before study start
- Pregnant, planning pregnancy during trial, breastfeeding, or childbearing potential without reliable contraception
- Have unresolved infections requiring active systemic antimicrobial treatment
- History of high-grade non-muscle invasive bladder cancer in past 6 months
- History of muscle-invasive bladder cancer in past 2 years
- Currently treated or planning treatment with intravesical or systemic chemotherapy during trial
- Urinary obstruction in the same side upper urinary tract
- Allergic or sensitive to gemcitabine or ST-02 ingredients
- Receiving another investigational drug or in clinical trial with investigational product within 30 days prior to study start
- Active hepatitis B or C infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Vancouver Prostate Centre
Vancouver, British Columbia, Canada
Actively Recruiting
2
Men's Health Clinic
Winnipeg, Manitoba, Canada, R3P 2S8
Actively Recruiting
3
Centre of Applied Urology Research, Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Actively Recruiting
4
UHN - Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Actively Recruiting
Research Team
D
Dasa Durkotova
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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