This study aims to evaluate the efficacy of disitamab vedotin combined with toripalimab as a bladder-preserving treatment combination in patients with HER2 positive locally advanced MIBC, including one year bladder-intact DFS (BI-DFS) and safety.
Voluntary agreement to participate in the study and provision of signed and dated informed consent form.
Male or female, aged ≥ 18 years.
Life expectancy of ≥ 18 months.
Pathologically and radiologically confirmed diagnosis of muscle-invasive bladder cancer (MIBC), clinical stage cT2-4aN0M0.
History of malignancies other than urothelial carcinoma, with the following exceptions:Patients who have received potentially curative therapy and have no evidence of the disease for 5 years.Adequately treated basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or other in situ carcinomas that have undergone curative resection.
Conditions affecting drug absorption, distribution, metabolism, or excretion.
Prior allogeneic stem cell or solid organ transplantation.Prior systemic anti-cancer therapy (including Chinese herbal medications with anti-cancer indications).Less than 4 weeks between the completion of prior therapy and the first dose of study treatment, or presence of persistent adverse events from previous treatments that have not recovered to ≤ Grade 1 per CTCAE (excluding alopecia or pigmentation).
History or current presence of congenital or acquired immunodeficiency diseases.