OncoMatch/Clinical Trials/NCT04617756
Safety & Efficacy of Durvalumab+Neoadjuvant Chemotherapy for High-risk Urothelial Carcinoma of the Upper Urinary Tract
Is NCT04617756 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Patients receiving neoadjuvant therapy before radical nephrectomy for urothelial carcinoma.
Treatment: Patients receiving neoadjuvant therapy before radical nephrectomy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Grade: high-grade
M0 No or N1 disease on CT scan.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
ANC > 1500/mm²; Platelet count > 100,000/mm³; Hemoglobin > 9.0 g/dL; INR and aPTT < 1.5x ULN
Kidney function
Cohort 1: eGFR > 60 ml/min/1.73m²; Cohort 2: eGFR 40-60 ml/min/1.73m² (CKD-EPI and/or MDRD equation)
Liver function
Bilirubin below 1.5x ULN; ASAT and ALAT below 2.5x ULN; Alkaline phosphatase below 2.5x ULN
Required initial laboratory values : Absolute neutrophil count of over 1500 cells/mm²; Platelet count of over 100,000 cells/mm3; Hemoglobin over 9.0 g/dL; Bilirubin below 1.5 times the Upper Limit of Normal for the institution; Aspartase transaminase (ASAT) and Alanine transaminase (ALAT) below 2.5 x the Upper Limit of Normal for the institution; Alkaline phosphatase below 2.5 times the Upper Limit of Normal for the institution; INR and aPTT below 1.5 times the Upper Limit of Normal for the institution. For Cohort 1 : An estimated glomerular filtration rate of over 60ml/min/1.73m² using the CKD-EPI and/or MDRD equation. For Cohort 2 : An estimated glomerular filtration rate of 40ml to 60ml/min/1.73m² using the CKD-EPI and/or MDRD equation.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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