This is a multicenter, open-label, prospective, single-arm, phase II study designed to evaluate the efficacy and safety of neoadjuvant zanidatamab combined with tislelizumab and chemotherapy, followed by selective bladder preservation, in patients with HER2-positive muscle-invasive bladder cancer (MIBC) staged cT2-4aN0-1M0.
Willing to participate, able to provide written informed consent, and able to understand and comply with study requirements and the assessment schedule.
Age 18 to 85 years on the date of informed consent.
Residual disease after TURBT; histologically confirmed urothelial carcinoma of the bladder staged cT2-T4aN0-1M0 per AJCC 8th edition by histology and imaging. For mixed histology, urothelial carcinoma must be predominant (≥50%).
Availability of TURBT tumor tissue and corresponding pathology report; either fresh surgical tissue or unstained slides may be submitted.
Pregnant or breastfeeding women.
Uncontrolled infection requiring systemic therapy.
Diagnosis of another malignancy within the past 5 years.
Major surgery or significant trauma within 28 days prior to enrollment (placement of a vascular access device and TURBT are not considered major surgery).
Fujian Medical University Union Hospital
Lead sponsor
BeiGene
Collaborator