A Phase 2 interventional study of Tislelizumab and Nab-paclitaxel in High-Risk and Non-Muscle Invasive Bladder Urothelial Carcinoma, sponsored by Tianjin Medical University Second Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-29.
Sponsored by Tianjin Medical University Second Hospital · Phase 2, Interventional, and Treatment
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.
6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's planned enrollment of 63 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Tianjin Medical University Second Hospital is the lead sponsor of 57 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
High-risk non-muscle-invasive urothelial carcinoma or high-risk non-muscle-invasive urothelial carcinoma as the main pathological component > 50%, difined as following:
a. T1 b. High-grade Ta c.Carcinoma in situ(CIS);
Organ function level must meet the following requirements:
Exclusion Criteria:
Uncontrolled concurrent diseases, including but not limited to:
Tislelizumab 200mg IV on day 1 in combination with nab-paclitaxel 200mg IV on day 2 every 3 weeks for 3 or 4 cycles followed by transurethral resection biopsy.
Drug: Tislelizumab · Drug: Nab-paclitaxel
Tislelizumab 200mg will be administered on Day 1 of each cycle for 4 treatment cycles.
Also known as: BGB-A317
Nab-paclitaxel 200mg will be administered on Day 2 of each cycle for 4 treatment cycles.
Complete 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)
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
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University Second Hospital