A Single-arm, Multicenter, Open Clinical Trial of the Efficacy and Safety of Tislelizumab in Combination With Nab-Paclitaxel for the Perioperative Treatment of Muscle-invasive Bladder Cancer
This is a single-arm, open-label, multicenter clinical trial to investigate the safety and efficacy of tislelizumab when given in combination with nab-paclitaxel as perioperative treatment in patients with muscle-invasive bladder cancer (MIBC) prior to cystectomy or complete TURBT. Patients will receive perioperative treatment with tislelizumab in combination with nab-paclitaxel every 3 weeks for 3 treatment cycles over 9 weeks followed by radical cystectomy or complete TURBT.
• Willing and able to provide written informed consent.
• Ability to comply with the protocol.
• Age ≥ 18 years.
• Suitable and planned for complete transurethral resection of bladder tumor or radical cystectomy
• At least one measurable lesion meeting RECISTv1.1 criteria prior to transurethral bladder tumor electrosurgery (MR/CT long diameter of ≥10 mm or short diameter of ≥15 mm of enlarged lymph node required for this measurable lesion according to RECISTv1.1)
• Histopathologically confirmed urothelial carcinoma. Patients with mixed histologies are required to have a dominant (i.e. 50% at least) urothelial cell pattern.
• Clinical stage T2-T4a NxM0 disease by CT (or MRI).
• Expected survival time is greater than 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 1 or 2.
⁃ Agree to provide tissue examination specimens (used to detect PD-L1 expression, tumor mutation burden, etc.)
⁃ The organ function level must meet the following requirements:
∙ Hematological indicators: absolute neutrophil count ≥1.5×10\^9/ L, platelet count ≥80×10\^9/L, hemoglobin ≥6.0 g/dL (can be maintained by symptomatic treatment);
‣ Liver function: total bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase
∙ ≤ 2.5 times the upper limit of normal value, if there is intrahepatic transaminase ≤ 5 times the upper limit of normal value;
‣ Renal function: creatinine ≤ 2 times the upper limit of normal, and creatinine clearance ≥ 30 ml/min;