Safety & Efficacy of Durvalumab+Neoadjuvant Chemotherapy for High-risk Urothelial Carcinoma of the Upper Urinary Tract
Status:
Recruiting
Trial end date:
2025-10-01
Target enrollment:
Participant gender:
Summary
Following radical nephrectomy (RNU) for upper tract urothelial carcinoma (UTUC) most patients
face a poor prognosis. Indeed, patients who have undergone RNU for UTUC have 5-year
recurrence-free and cancer specific survival probabilities of 69% and 73% respectively.
The primary objective of this study is to assess the pathological complete response rate to
combination therapy with neoadjuvant durvalumab and chemotherapy (Gemcitabine/Cisplatin)
before surgery in patients with high-risk, localized, non-metastatic urothelial carcinomas of
the upper tract.
Phase:
Phase 2
Details
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Collaborators:
Centre Hospitalier Lyon Sud European Georges Pompidou Hospital Hôpital Bichat-Claude Bernard, 75018 Paris Hopital Foch 92151 Suresnes Hôpital Pontchaillou, 35033 Rennes Institut Paoli-Calmettes Pitié-Salpêtrière Hospital Rangueil Hospital Saint-Louis Hospital, Paris, France University Hospital, Toulouse