Study of Neoadjuvant Zanidatamab with Tislelizumab and Chemotherapy for Bladder Preservation in Patients with HER2-Positive Muscle-Invasive Bladder Cancer

What this Trial Is About

Researchers are investigating a new treatment approach for patients with HER2-positive muscle-invasive bladder cancer MIBC staged cT2-4aN0-1M0. This phase II, multicenter, open-label study evaluates combining zanidatamab and tislelizumab with chemotherapy before surgery, aiming to preserve the bladder selectively. The study focuses on assessing the treatments effectiveness and safety in this specific patient group. Participants receive neoadjuvant therapy consisting of zanidatamab, tislelizumab, and chemotherapy drugs such as cisplatin, gemcitabine, or nab-paclitaxel over four cycles, each lasting 21 days. After these initial treatments, patients are reassessed for clinical complete response cCR. Those achieving cCR continue maintenance therapy with zanidatamab and tislelizumab, while others may undergo radiotherapy or partial cystectomy followed by maintenance therapy or proceed directly to radical cystectomy with adjuvant tislelizumab. Throughout the trial, participants undergo regular evaluations including tumor assessments and safety monitoring. The main outcome is the rate of clinical complete response at the end of neoadjuvant therapy. Secondary outcomes include disease-free survival rates, recurrence-free survival, overall survival, safety, and quality of life measures over up to three years. The study aims to understand how well this treatment strategy can preserve the bladder and improve patient outcomes.

Neoadjuvant Zanidatamab + Tislelizumab + Chemotherapy for Selective Bladder Preservation in HER2-Positive MIBC