NCT07125547

Neoadjuvant Tislelizumab + Nab-Paclitaxel Followed by Distal Ureterectomy for Ureteral Cancer

Neoadjuvant Tislelizumab Combined With Nab-Paclitaxel Followed by Distal Ureterectomy for Ureteral Cancer: An Open-Label, Single-Center, Single-Arm, Phase II Clinical Trial (TRUCE-U01)

• 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 and safety of neoadjuvant Tislelizumab combined with Nab-Paclitaxel followed by distal ureterectomy for patients with non-metastatic ureteral cancer (UTC). Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo distal ureterectomy (DU). The assessment of efficacy is based on the histology of specimen from DU, and treatment-related adverse events (TRAEs) will be recorded and evaluated according to CTCAE 5.0.

Conditions

• Ureteral Cancer
• Neoadjuvant Therapy
• PD-1 Inhibitor
• Kidney-sparing
• Tislelizumab
• Nab-paclitaxel

Interventions

Type	Name	Description
DRUG	PD-1 inhibitior	Tislelizumab 200mg iv will be administered on Day 1 every 3 weeks for 2-3 cycles.
DRUG	Nab-paclitaxel	Nab-Paclitaxel 125mg/m2 IV will be administered on Day 1 every 3 weeks for 2-3 cycles
PROCEDURE	distal ureterectomy	Distal ureterectomy (Distal ureterectomy + Partial cystectomy +Psoas hitch procedure + Ureteral reimplantation into the bladder + Ipsilateral pelvic lymph node dissection) will be conducted after neoadjuvant treatment.

Timeline

• Start date: 2025-07-05
• Primary completion: 2026-12-30
• Completion: 2030-12-30
• First posted: 2025-08-15
• Last updated: 2025-08-15

Locations

1 site across 1 country: China