Study design and patients
MIBC, bladder cancer, bladder lesion, autoimmune or immunodeficiency disease
ONCOLOGY, METASTASIS, BLADDER CANCER
This investigator‐initiated, multicenter clinical trial evaluated the benefit of neoadjuvant therapy with camrelizumab plus GC in patients with MIBC. The study consisted of two stages: a single‐arm pilot study in the first stage to investigate the combination regimen's efficacy and safety in patients with local advanced resectable MIBC, followed by a randomized controlled study in the second stage to further compare the combination regimen with chemotherapy alone. The second stage would initiate when the first stage met the primary endpoint. Institutional review boards of all participant centers approved the study, and all patients provided informed consent to participate. This study was registered on Eligible patients were at least 18 years old, diagnosed with histologically confirmed local advanced resectable bladder cancer without metastasis (variant histology allowed without restrictions), naïve to platinum‐based systemic therapy, had at least one measurable bladder lesion according to the RECIST 1.1 criteria, clinical stage of T2‐4aN0‐1M0, scheduled for RC, Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1, anticipated living longer than 3 months, and had normal hematologic test and sufficient organ function at baseline. Patients with autoimmune or immunodeficiency disease, requiring immunosuppressive therapy in the past 2 weeks, or any other conditions unsuitable for this study, as evaluated by investigators, were excluded.