DUMELEP
- Conditions
- Hepatocellular carcinoma (HCC)MedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2022-003561-38-FR
- Lead Sponsor
- Assistance publique - Hôpitaux de Paris
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
- Male or female patients = 18 years of age
- Histological or radilogical diagnosis of HCC
- Patients with newly diagnosed or recurrent HCC (following a previous curative procedure performed at least 6 months before inclusion) eligible for IRE as assessed by multidisciplinary board corresponding to BCLC A stage:
x Uninodular HCC = 2 cm and = 5 cm, no macroscopic vascular invasion
x Multinodular maximum 3 nodules = 3 cm, Body weight >30 kg
x At least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified RECIST for HCC
x Liver function status Child-Pugh Class A
x <><
- Adequate bone marrow, liver and renal function as assessed by the following laboratory tests:
x Total bilirubin = 2 mg/dL
x Serum creatinine = 1.5 x ULN
x Lipase = 2 x ULN
x Prothrombine time-international normalized ratio (PT-INR) < 2.3 and PTT < 1.5
x Glomerular Filtration Rate (GFR) = 30 mL/min/1.73 m2
- Life expectancy = 3 months
- Women of childbearing potential (WOCBP) need to accept one effective method of contraception until 3 months after the last infusion of durvalumab and avoid pregnancy
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or180 days after the last dose of durvalumab and tremelimumab combination therapy.
- Patients affiliated to a Social Security System
- Written informed consent signed
- Haemoglobin =9.0 g/dL
- Absolute neutrophil count (ANC =1.0 × 109 /L)
- Platelet count =75 × 109/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:
Males:
Creatinine CL (mL/min) = Weight (kg) x (140 – Age)
72 x serum creatinine (mg/dL)
Females:
Creatinine CL (mL/min) = Weight (kg) x (140 – Age) x 0.85
72 x serum creatinine (mg/dL)
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to inclusion
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range 30
Not enough room: see protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method