NCT07126119

Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for UTUC

Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for Upper Tract Urothelial Carcinoma: An Open-Label, Single-Center, Single-Arm, Phase II Clinical Trial (TRUCE-U02)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Tianjin Medical University Second Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed as an open-label, single-arm, single center, phase II clinical trial, aiming to evaluate the efficacy of neoadjuvant Tislelizumab combined with Nab-Paclitaxel for patients with non-metastatic upper tract urothelial carcinoma (UTC). Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo radical nephroureterectomy (RNU). The assessment of efficacy is based on the histology of specimen from RNU, and treatment-related adverse events (TRAEs) will be recorded and evaluated according to CTCAE 5.0.

Conditions

• Upper Tract Urothelial Carcinoma
• Neoadjuvant Therapy
• PD-1 Inhibitor
• Nab-paclitaxel

Interventions

Type	Name	Description
DRUG	Nab-Paclitaxel	Nab-Paclitaxel 125mg/m\^2 IV will be administered on Day 1 every 3 weeks for 2-3 cycles
DRUG	Tislelizumab	Tislelizumab 200mg iv will be administered on Day 1 every 3 weeks for 2-3 cycles.
PROCEDURE	Radical nephroureterectomy (RNU)	Radical nephroureterectomy (RNU) will conducted after the completion of neoadjuvant therapy.

Timeline

• Start date: 2025-07-05
• Primary completion: 2026-12-30
• Completion: 2030-12-30
• First posted: 2025-08-17
• Last updated: 2025-08-17

Locations

1 site across 1 country: China