Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)

This is a phase III, single-arm, multicenter, international study to assess the efficacy and safety of ONCOFID-P-B following intravesical instillation in adult patients with histologically and cytologically confirmed CIS, with or without concomitant Ta-T1, who are unresponsive to BCG therapy and unwilling or unfit to undergo radical cystectomy. After providing written informed consent (in presence of an Independent Witness, if applicable), patients will receive an induction therapy consisting of 12 weekly intravesical instillations of ONCOFID-P-B (induction phase). Patients who achieve a CR by Investigator assessment at the end of the induction phase will enter the maintenance phase and receive monthly treatment for an additional 12 months or until recurrence of CIS/Ta-T1 or progression to MIBC or extravesical disease.