Overview
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.
Description
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.
Eligibility
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.