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NCT07155044
A Comparative Study of Neoadjuvant Chemotherapy Versus Upfront Radical Surgery for Upper Tract Urothelial Carcinoma
trial testing NAC in UTUC in 120 participants. Participants enrolled and being followed up; not accepting new ones.
15 May 2027
Quick facts
| Lead sponsor | Changhai Hospital |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 120 |
| Start date | 15 May 2024 |
| Primary completion | 15 May 2027 |
| Estimated completion | 15 May 2029 |
| Sites | 1 location across China |
Drugs / interventions tested
- NAC — full drug profile →
Conditions studied
- UTUC — all drugs for UTUC →
- UC (Urothelial Cancer) — all drugs for UC (Urothelial Cancer) →
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.
Verify or expand the search:
- PubMed search for NCT07155044
- Europe PMC full search
- ASCO Meeting Library
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Other recruiting trials for UTUC
Currently open trials in the same condition.
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- NCT06991868 — A Multicenter Prospective Cohort Study on Monitoring Recurrence of Urothelial Carcinoma Based on Detection of Urinary Mi · recruiting
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Other Changhai Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07155044 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Changhai Hospital
- Last refreshed: 4 September 2025
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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