drugset / Trial / NCT06927128

Neoadjuvant Chemotherapy in High - Risk Upper Tract Urothelial Carcinoma

NCT06927128 ↗

Phase 2 Not yet recruiting 45 enrolled Changhai Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-05-15
Primary completion
2026-05-15
Completion
2028-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 70 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous

Indications

No indication recorded.