RecruitingPhase 2Phase 3NCT06124976

Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma

A Phase 2/3 Multicenter Trial Evaluating the Safety and Efficacy of ST-02 (Mucoadhesive Gemcitabine Suspension) on Ablation of Urothelial Carcinomas in the Upper Urinary Tract

Sponsor

University of British Columbia

Enrollment

70 participants

Start Date

Jun 19, 2024

Study Type

INTERVENTIONAL

Conditions

Urothelial Carcinoma of the Renal Pelvis and Ureter Transitional Cell Cancer of the Renal Pelvis and Ureter

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called ST-02 (which contains gemcitabine, a chemotherapy agent) delivered directly into the kidney to treat low-grade, non-invasive tumors in the upper urinary tract (called urothelial carcinoma). It aims to treat small tumors without removing the kidney. **You may be eligible if:** - You are 18 or older - You have low-grade, non-invasive urothelial tumors in your kidney collecting system (renal pelvis or calyces), confirmed by a scope procedure and biopsy within 8 weeks - You have at least one tumor between 5–15 mm - You have no active urinary tract infection - Your life expectancy is more than 12 months **You may NOT be eligible if:** - You received BCG treatment for these tumors within the past 6 weeks - You are pregnant, breastfeeding, or planning pregnancy during the trial - You have a high-grade or muscle-invasive bladder cancer history in the past 6–24 months - You are currently receiving chemotherapy - You have active hepatitis B or C - You have a known allergy to gemcitabine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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