Clinical Trial

Neoadjuvant Chemotherapy Before Surgery vs Surgery Alone for UTUC: A Randomized Trial

Active, Not Recruiting Phase 2
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Summary
This clinical trial aims to compare the effectiveness and safety of two treatment options for patients with high-risk upper tract urothelial carcinoma (UTUC). One group will receive neoadjuvant chemotherapy with gemcitabine and cisplatin followed by surgery (radical nephroureterectomy), while the other group will undergo surgery without chemotherapy. The primary goal is to assess the pathological response to treatment, focusing on how much the tumor shrinks before surgery. The trial will also evaluate the safety of the treatments, overall survival, and recurrence-free survival. This study will help determine whether adding chemotherapy before surgery improves outcomes for patients with high-risk UTUC.
Trial Details
NCT Number NCT07492225
Lead Sponsor Changhai Hospital
Conditions Neoadjuvant Therapy, Urothelial Carcinoma Ureter, Upper Urinary Tract Urothelial Carcinoma
Enrollment 120 participants
Start Date 2025-08-15
Primary Completion 2027-08-15 (estimated)
Study Completion 2029-08-15 (estimated)
Updated on ClinicalTrials.gov 2026-03-25