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Neoadjuvant Tislelizumab and Nab-Paclitaxel for Ureteral Cancer
NCT07125547Phase 2
Key facts
- Status
- Recruiting
- Start
- Jul 2025
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- The Second Hospital of Tianjin Medical University
- Modality
- Monoclonal Antibodies
- Drugs
- tislelizumab
- Conditions
- ureteral cancer
01
Overview
Phase 2, open-label, single-arm trial of tislelizumab in ureteral cancer, sponsored by The Second Hospital of Tianjin Medical University. Primary endpoint: Pathological Complete Response at 14 weeks. Started Jul 2025; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Experimental Arm
Neoadjuvant Tislelizumab + Nab-Paclitaxel followed by Distal Ureterectomy
03
Who it enrols
Adult patients with histologically confirmed non-metastatic ureteral cancer (T1-4N0-2M0) suitable for distal ureterectomy, with adequate organ function and no prior PD-1/PD-L1 treatment.
04
Endpoints
Primary
Pathological Complete Response
Secondary
Treatment-related adverse events
Pathological Downstaging
Objective Response
Events-Free Survival
Overall Survival
Recurrence-Free Survival
Cancer-Specific Survival
Nephron-Sparing Survival
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