OncoMatch/Clinical Trials/NCT06045975
Durvalumab/Tremelimumab in Neoadjuvant and Adjuvant Setting in Patients With HCC Treated by by Percutaneous Ablation Procedure
Is NCT06045975 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Durvalumab/Tremelimumab in neoadjuvant and Durvalumab in adjuvant setting for hcc - hepatocellular carcinoma.
Treatment: Durvalumab/Tremelimumab in neoadjuvant and Durvalumab in adjuvant setting — This project is a Phase 2 trial testing the safety and efficacy of treatment with Durvalumab/Tremelimumab in neoadjuvant and Durvalumab in adjuvant setting in patients with BCLC A HCC treated by by percutaneous ablation (PA) procedure in a curative intent. DUMELEP is a Multicentre, Phase 2 trial Eligible patients will receive consecutively: 1. 1 Durvalumab 1500 mg/Tremelimumab 300 mg infusion in a neoadjuvant setting 2. percutaneous ablation procedure in a curative attempt at Day 30 3. 11 monthly Durvalumab 1500 mg infusions. 4. Classical follow-up during an additional year (every 3 months)
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage BCLC A (BCLC)
eligible for PA as assessed by multidisciplinary board corresponding to BCLC A stage
Performance status
ECOG/WHO 0–1
Prior therapy
Cannot have received: systemic therapy
Prior systemic treatment for HCC, in particular agents targeting T-cell costimulation or checkpoint pathways (including those targeting PD-1, PD-L1 or PD-L2, CD137, or cytotoxic T-lymphocyte antigen [CTLA-4])
Cannot have received: anti-PD-1 therapy
Patients who have received prior anti-PD-1, anti-PD-L1 or anti-CTLA-4
Cannot have received: anti-PD-L1 therapy
Patients who have received prior anti-PD-1, anti-PD-L1 or anti-CTLA-4
Cannot have received: anti-CTLA-4 therapy
Patients who have received prior anti-PD-1, anti-PD-L1 or anti-CTLA-4
Lab requirements
Blood counts
Haemoglobin ≥9.0 g/dL; Absolute neutrophil count (ANC) ≥1.0 × 10^9/L; Platelet count ≥75 × 10^9/L; Prothrombine time-international normalized ratio (PT-INR) < 2.3 and PTT < 1.5
Kidney function
Serum creatinine ≤ 1.5 x ULN; GFR ≥ 30 mL/min/1.73 m2; Measured or calculated creatinine clearance >40 mL/min
Liver function
Total bilirubin ≤ 2 mg/dL; Serum bilirubin ≤1.5 x institutional ULN (except Gilbert's syndrome); AST (SGOT) and ALT (SGPT) ≤5x ULN; Liver function status Child-Pugh Class A
Adequate bone marrow, liver and renal function as assessed by the following laboratory tests: Total bilirubin ≤ 2 mg/dL; Serum creatinine ≤ 1.5 x ULN; Lipase ≤ 2 x ULN; Prothrombine time-international normalized ratio (PT-INR) < 2.3 and PTT < 1.5; GFR ≥ 30 mL/min/1.73 m2; Haemoglobin ≥9.0 g/dL; Absolute neutrophil count (ANC) ≥1.0 × 10^9/L; Platelet count ≥75 × 10^9/L; Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). (This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.); AST (SGOT) and ALT (SGPT) ≤5x ULN; Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine clearance CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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