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RECRUITING
NCT07126119
PHASE2

Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for UTUC

Sponsor: Tianjin Medical University Second Hospital

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2025-07-05

Completion Date

2030-12-30

Last Updated

2025-08-17

Healthy Volunteers

No

Interventions

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.

Locations (1)

The Second Hospital of Tianjin Medical University

Tianjin, Outside U.S., China