Clinical Trial

Neoadjuvant Chemotherapy in High - Risk Upper Tract Urothelial Carcinoma

Not Yet Recruiting Phase 2
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Record status
This record was last updated April 15, 2025 (before its estimated May 15, 2026 completion). Its status may not reflect the trial's current state.
Summary
Upper urinary tract urothelial carcinoma (UTUC) represents a rare yet aggressive malignancy associated with a dismal prognosis. At the point of diagnosis, nearly half of the patients already have invasive disease, and over 70% present with high-grade UTUC. Currently, radical nephroureterectomy (RNU) remains the gold standard of care for high-risk UTUC. Previous investigations have demonstrated that, in contrast to RNU alone, chemotherapy can effectively reduce the disease recurrence rate and mortality. Moreover, it may confer benefits to patients' overall survival (OS) without impeding the implementation of subsequent definitive surgical treatment. However, the majority of these studies are predominantly retrospective analyses. Although they can, to some degree, reflect the clinical value of neoadjuvant chemotherapy, due to inherent limitations in study design and other confounding factors, there is still a paucity of prospective research evidence for further validation. Considering that RNU can cause a decline in renal function in patients, and in light of prospective trial outcomes, preoperative neoadjuvant chemotherapy (NAC) has emerged as a preferred treatment option for chemotherapy-eligible UTUC patients.
Trial Details
NCT Number NCT06927128
Lead Sponsor Changhai Hospital
Conditions UTUC, NAC
Enrollment 45 participants
Start Date 2025-05-15
Primary Completion 2026-05-15 (estimated)
Study Completion 2028-06-15 (estimated)
Updated on ClinicalTrials.gov 2025-04-15