This is a phase II study to determine 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 treatment with tislelizumab in combination with nab-paclitaxel every 3 weeks for 3 treatment cycles over 9 weeks followed by standard radical cystectomy or complete TURBT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Tislelizumab 200mg will be administered on Day 1 every 3 weeks for 3 cycles
Nab paclitaxel 200mg will be administered on Day 2 every 3 weeks for 3 cycles
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, China
Clinical Complete Response (cCR) rate
defined as the absence of tumor residual confirmed by surgery (RC-PLND or complete TURBT), negative urine cytology and no evidence of lymph nodes or distant metastasis on imaging.
Time frame: At the time of complete transurethral resection of bladder tumor or radical cystectomy (within 12 weeks of the first dose of tislelizumab)
Objective response rate (ORR)
defined as the proportion of patients who have a partial or complete response to therapy.
Time frame: At the time of complete transurethral resection of bladder tumor or radical cystectomy (within 12 weeks of the first dose of tislelizumab)
Event-free survival (EFS)
defined from D1 of neoadjuvant treatment until progression (in those who progress prior to surgery) or until recurrence (post-surgery) or until death as a result of any cause.
Time frame: up to 3 years
Overall Survival (OS)
defined as the number of days from study entry to death. Individuals who are alive at last contact will be censored on the date of last contact.
Time frame: up to 3 years
Disease-specific survival (DSS)
DSS was documented from the date of initial treatment till the date of the disease-related death.
Time frame: up to 3 years
Number of adverse events and severity by grade (CTCAE)
Safety and toxicity will be characterized according to the reported adverse event (AE) profile using NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0, as well as a patient questionnaire derived from the Patient Reported Outcomes (PRO)-CTCAE and Patient Reported Outcomes Measurement Information System (PROMIS).
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Time frame: up to 1 years