This is a phase II study to determine the safety and efficacy of tislelizumab when given in combination with nab-paclitaxel as treatment for patients with high-risk non-muscle-invasive bladder cancer (HR NMIBC) which is not completely resectable. Patients will receive treatment with tislelizumab in combination with nab-paclitaxel every 3 weeks for 4 treatment cycles over 12 weeks followed by transurethral resection biopsy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Tislelizumab 200mg will be administered on Day 1 of each cycle for 4 treatment cycles;Nab-paclitaxel 200mg will be administered on Day 2 of each cycle for 4 treatment cycles.
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGComplete Response (CR) Rate for tilelizumab combined with nab-paclitaxel
Time frame: At the time of transurethral resection biopsy (within 9 or 12 weeks of the first dose of tislelizumab)
Cystectomy-Free Survival (CFS)
defined from D1 of treatment until cystectomy
Time frame: up to 3 years
Duration of Response (DOR)
Time frame: up to 3 years
Number of adverse events and severity by grade (CTCAE) 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).
Time frame: 12 weeks of treatment plus 30 days for toxicity followup
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