About this trial
This study aims to evaluate the efficacy and safety of neoadjuvant trastuzumab rezetecan combined with adebrelimab for the treatment of HER2-positive muscle-invasive bladder cancer.
Eligibility criteria
Qualifiers
Age ≥18 years.
ECOG performance status of 0 or 1.
Histopathologically diagnosed muscle-invasive bladder cancer (MIBC) (cT2-T4a, N0-1, M0).
Tumor tissue with HER2 expression (IHC 2+ or 3+) and suitable for radical cystectomy (RC) and transurethral resection of bladder tumor (TURBT).
Disqualifiers
Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, etc.); patients with vitiligo; patients with childhood asthma that has completely resolved and requires no intervention in adulthood may be included; patients with asthma requiring bronchodilators for medical intervention are excluded.
Patients currently using immunosuppressants or systemic corticosteroids for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent) and continuing use within 2 weeks before the first dose.
History of severe allergic reactions to other monoclonal antibodies.
Subjects with untreated central nervous system (CNS) metastases; subjects who have received prior systemic, radical treatment for brain or leptomeningeal metastases (radiotherapy or surgery) may be included if imaging confirms stability for at least 1 month, systemic corticosteroid therapy (dose >10 mg/day prednisone or equivalent) has been discontinued for more than 2 weeks, and they are asymptomatic.
Trial design
Treatments tested in this trial
- Trastuzumab Rezetecan Combined with Adebelizumab
Treatment groups
Locations
Sponsors and collaborators
Harbin Medical University
Lead sponsor
The Fourth Affiliated Hospital of China Medical University
Collaborator
Jilin Provincial Tumor Hospital
Collaborator
Tianjin Medical University Second Hospital
Collaborator
First Hospital of China Medical University
Collaborator