NCT07019220 Chemoablation for Low-Grade Bladder Cancer

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 47 participants in total. It began in 2023-12-27 with a primary completion date of 2027-11.

Brief Summary

The goal of this single arm, prospective, open-label, investigator-initiated Phase 2 clinical trial is to evaluate the efficacy of intravesical chemoablation in patients with low grade bladder cancer.

Eligibility Criteria

Inclusion Criteria: * Male/female participants who are at least 18 years of age on the day of providing documented informed consent will be enrolled in this study * Diagnosis of a recurrent tumor and a history of TaLG BCa or diagnosis of primary TaLG BCa histologically confirmed by cold cup biopsy at screening or within 8 weeks before screening * On screening cystoscopy: Diameter of the largest lesion ≤15mm * Number of lesions ≤5 * Cystoscopy with bladder diagram including number, site, size and appearance of the tumors with photo documentation * Patient who has recurrence of and not other than TaLG NMIBC (low or intermediate EAU risk) * NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT) * Negative voiding cytology for high grade (HG) disease within 8 weeks before Screening * No lymph node metastasis or distant metastasis * Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment * Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. Female patients of childbearing potential must use adequate contraception during study period * Willing and able to provide informed consent Exclusion Criteria: * Tumors that clinicians suspect to be HG * Positive HG cytology according to Paris criteria * Diameter of tumor \>15 mm * Number of lesions \>5 * Any previous intravesical therapy within 1 year * Previous HG NMIBC (within the last 3 years). It is allowed to include patients who had history of HG disease longer than 3 years ago. * Past or current muscle invasive bladder cancer (i.e., T2, T3, T4) or metastatic UC * History of upper tract urothelial carcinoma (UTUC) * Clinically significant urethral stricture that would preclude passage of a urethral catheter * History of neurogenic bladder; active urinary retention; any other condition that would prohibit normal voiding * Evidence of active urinary tract infection (UTI) that in the Investigator's opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment * Patient refused to participate * Known positive human immunodeficiency virus (HIV) test. * Female patients who are pregnant/breastfeeding. * Female patients of childbearing potential not using adequate contraception.

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