Study of Intravesical Gemcitabine and Docetaxel for Adults with High-Risk BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer Evaluating Effectiveness and Safety of Weekly and Monthly Bladder Treatments as an Alternative to Surgery

What this Trial Is About

Researchers are evaluating whether a combination of two chemotherapy drugs, Gemcitabine and Docetaxel, can treat adults with high-grade non-muscle-invasive bladder cancer HG-NMIBC that has not responded to conventional BCG therapy. This study aims to see if this drug combination, given directly into the bladder, can prevent the cancer from returning and provide long-term protection, while also assessing the safety of this treatment. The goal is to find a bladder-sparing alternative to bladder removal surgery for these patients. Participants receive weekly bladder treatments of Gemcitabine followed immediately by Docetaxel for six weeks during the initial induction phase. If the cancer responds, they continue with monthly maintenance treatments for up to two years. Treatments are delivered directly into the bladder via catheter and each drug is held in the bladder for about 60 minutes. The study includes two groups one with carcinoma in situ CIS and another with high-grade papillary tumors without CIS. During the study, participants undergo screening including tumor removal and imaging tests. They attend regular check-ups that include bladder exams, urine tests, and biopsies. Quality of life surveys are optional. If cancer returns early, a second six-week treatment cycle may be given. Participants are followed for up to five years to monitor long-term outcomes, treatment safety, and cancer recurrence or progression.

Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC