Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC

The goal of this clinical trial is to learn whether a combination of two chemotherapy drugs, Gemcitabine and Docetaxel, can treat high-grade non-muscle-invasive bladder cancer (HG-NMIBC) in adults whose cancer failed conventional BCG therapy. The drugs are given directly into the bladder (intravesically), one immediately after the other. The study will also assess the safety of this treatment. The main questions it aims to answer are: Can this drug combination effectively treat HG-NMIBC that did not respond to BCG and help prevent the cancer from coming back, offering long-term protection?

Trial Details

NCT ID

NCT07322263

Phase

PHASE2

Sponsor

Michael A. O'Donnell

Status

RECRUITING

Cancer Type

Non-Muscle-Invasive Bladder Cancer

Interventions

Intravesical Gemcitabine and Docetaxel

Locations (sample)

Iowa City, Iowa, United States|41.66113,-91.53017

Key Eligibility Criteria

Histologically confirmed diagnosis of urothelial carcinoma of the bladder without synchronous or metachronous upper tract involvement or prostatic …
Eligible bladder cancer presentations include:
Carcinoma in situ (CIS), with or without non-muscle-invasive stage Ta or T1 tumors of any grade.
High-Grade Papillary tumors (stages Ta and/or T1) without CIS.

For full eligibility, visit ClinicalTrials.gov.

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