Chemoablation for Low-Grade Bladder Cancer

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

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.

Conditions2

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