Chemoablation for Low-Grade Bladder Cancer

In this study, patients with histologically confirmed Ta low-grade bladder cancer will undergo chemoablation with gemcitabine (six weekly instillations). The study aims to evaluate the efficacy, safety, and tolerability of chemoablation.

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.