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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT04617756 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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