Tilelizumab Combined With Nab-Paclitaxel for High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable
NCT04730232 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63
Last updated 2021-10-29
Summary
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.
Conditions
- High-Risk
- Non-Muscle Invasive Bladder Urothelial Carcinoma
Interventions
- DRUG
-
Tislelizumab
Tislelizumab 200mg will be administered on Day 1 of each cycle for 4 treatment cycles.
- DRUG
-
Nab-paclitaxel 200mg will be administered on Day 2 of each cycle for 4 treatment cycles.
Sponsors & Collaborators
-
Tianjin Medical University Second Hospital
lead OTHER
Principal Investigators
-
Hailong Hu, MD,PhD · Tianjin Medical University Second Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-27
- Primary Completion
- 2024-02-29
- Completion
- 2024-07-31
Countries
- China
Study Locations
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