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Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for UTUC

NCT07126119 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-08-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Tianjin Medical University Second Hospital

    lead OTHER

Principal Investigators

  • Hailong Hu, PhD · Tianjin Medical University Second Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07126119 on ClinicalTrials.gov