Antibody-Drug Conjugate Plus Immunotherapy Versus Immunotherapy Plus Chemotherapy for Extensive Transurethrally Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer

Korábbi kezelés

• Previous treatment with antibody-drug conjugates, immune checkpoint inhibitors, or systemic chemotherapy for bladder cancer.
• Clinically significant peripheral neuropathy or other conditions that would preclude treatment with the study medications.
• Concurrent participation in another interventional clinical trial involving investigational anticancer treatment.

Más betegség

• Histologically confirmed muscle-invasive bladder cancer (≥T2), lymph node metastasis, or distant metastasis.
• Active autoimmune disease requiring systemic immunosuppressive treatment, or other contraindications to immune checkpoint inhibitor therapy.
• Active or uncontrolled infection, or other clinically significant uncontrolled medical conditions that may compromise patient safety.
• Known severe hypersensitivity to any study medication or its components.
• Any other condition that, in the investigator's judgment, would make participation inappropriate or interfere with the assessment of study outcomes.

Egyéb

• Predominantly non-urothelial histology, including pure squamous cell carcinoma, adenocarcinoma, or neuroendocrine carcinoma.
• Pregnancy or breastfeeding.

• Patients aged 18 years or older.
• Histologically confirmed urothelial carcinoma of the bladder, classified as very-high-risk non-muscle-invasive bladder cancer (VHR NMIBC) according to the European Association of Urology (EAU) risk classification.
• Extensive bladder tumors that cannot be completely resected transurethrally, defined by at least one of the following criteria:
  • A solitary or confluent tumor with a maximum diameter greater than 5 cm;
  • Multifocal tumors involving more than 30% of the bladder mucosal surface.
  • Transurethral unresectability must be independently confirmed by at least two experienced urologists.
• HER2 expression confirmed by immunohistochemistry (IHC 1+, 2+, or 3+).
• No prior systemic anticancer therapy for cancer.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Adequate hematologic, hepatic, and renal function to receive the study treatments.
• Ability to understand the study requirements and willingness to provide written informed consent.