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NCT07155044

A Comparative Study of Neoadjuvant Chemotherapy Versus Upfront Radical Surgery for Upper Tract Urothelial Carcinoma

Sponsor: Changhai Hospital

View on ClinicalTrials.gov

Summary

This is a single-center, open-label, non-randomized controlled trial comparing the efficacy and safety of neoadjuvant chemotherapy (NAC) followed by radical surgery versus upfront radical surgery alone in patients with high-risk, non-metastatic upper tract urothelial carcinoma (UTUC). The study aims to answer the following key questions: Does NAC improve pathologic response rates (defined as downstaging to \<ypT2N0) compared to immediate surgery? What is the rate of pathologic complete response (pCR; ypT0N0) in the NAC group? How do the two treatment strategies compare in terms of overall survival, cancer-specific survival, and recurrence-free survival? What is the safety and tolerability profile of NAC using gemcitabine and cisplatin in this patient population? Eligible participants will be assigned to either the NAC-plus-surgery group or the surgery-only group based on clinical evaluation and patient preference. The study will also explore potential biomarkers (e.g., chromosomal instability in liquid biopsies) for predicting treatment response. Key Eligibility Criteria: Adults with histologically confirmed high-risk UTUC Clinical stage ≤N1 M0 Adequate renal function (GFR ≥45 mL/min) and ECOG performance status 0-1 Primary Outcome: Pathologic response rate (proportion of patients with \<ypT2N0)

Official title: Evaluating the Application Value of Neoadjuvant Chemotherapy Compared to Upfront Surgery in Patients With Upper Tract Urothelial Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2024-05-15

Completion Date

2029-05-15

Last Updated

2025-09-04

Healthy Volunteers

No

Interventions

DRUG

NAC

Participants in NAC+RNU cohort will receive 3-4 cycles of neoadjuvant chemotherapy (NAC) with the gemcitabine and cisplatin (GC) regimen prior to undergoing definitive surgery. Gemcitabine (1000 mg/m²) will be administered on Day 1 and Day 8, and cisplatin (70 mg/m²) will be administered on Day 2 of each 21-day cycle.

Locations (1)

Changhai Hospital

Shanghai, Shanghai Municipality, China