Efficacy and Safety of Two Bladder-preserving Treatment Durations With Disitamab Vedotin Plus Toripalimab Combination in Her2-expressing Muscle-invasive Bladder Cancer: A Phase II, Open-Label, Randomized Clinical Trial

Prior treatment

• 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).

Other illness

• 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.
• History or current presence of congenital or acquired immunodeficiency diseases.
• Active or documented history of autoimmune or inflammatory disorders.

• 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.
• Ability to provide tumor tissue specimen from the primary site for HER2 testing; HER2 expression of IHC 1+, 2+, or 3+.
• No prior systemic therapy for bladder cancer.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate cardiac, bone marrow, hepatic, and renal function (as per the reference ranges of the investigating center).