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NCT07155044

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

Active, enrolled Last updated 4 September 2025
What this trial tests

trial testing NAC in UTUC in 120 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
15 May 2024
Primary endpoint
15 May 2027
15 May 2029

Quick facts

Lead sponsorChanghai Hospital
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment120
Start date15 May 2024
Primary completion15 May 2027
Estimated completion15 May 2029
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Changhai Hospital

Who can join

18 and older, any sex, with UTUC or UC (Urothelial Cancer). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of NAC

Trials testing the same drug.

Other recruiting trials for UTUC

Currently open trials in the same condition.

Other Changhai Hospital trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07155044.

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