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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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;

Locations
Other Locations
China
ianjin Medical University Second Hospital
RECRUITING
Tianjin
Contact Information
Primary
Hailong Hu, MD,PhD
hhllove2004@163.com
+86-13662096232
Time Frame
Start Date: 2021-11-11
Estimated Completion Date: 2025-11
Participants
Target number of participants: 74
Treatments
Experimental: Experimental: Tislelizumab and Nab Paclitaxel
Experimental: Tislelizumab and Nab Paclitaxel Tislelizumab 200mg IV on day 1 in combination with nab paclitaxel 200mg IV on day 2 every 3 weeks for 3 cycles followed by surgery.
Sponsors
Leads: Tianjin Medical University Second Hospital

This content was sourced from clinicaltrials.gov