drugset / Trial / NCT07126119

Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for UTUC

NCT07126119 ↗

Phase 2 Recruiting 35 enrolled Tianjin Medical University Second Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-07-05
Primary completion
2026-12-30
Completion
2030-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Nab-paclitaxel Small molecule 125 mg/m2 Intravenous
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous