Hepatocellular carcinoma (HCC) MedDRA version: 20.0 Level: PT Classification code 10073071 Term: Hepatocellular carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: IMFINZI®
Product Name: Durvalumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Durvalumab
Current Sponsor code: Durvalumab
Concentration unit: mg/ml mill
Sponsors
Assistance publique - Hôpitaux de Paris
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 >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
Exclusion criteria
Exclusion criteria: Not enough room: see protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess local recurrence-free survival at 1-year following neoadjuvant/adjuvant Durvalumab/Tremelimumab and adjuvant Durvalumab therapy associated with IRE procedure in patients with BCLC A HCC;Secondary Objective: - To assess the changes of tumorous and non-tumorous perfusion parameters observed with MRI after one months of neoadjuvant treatments - To assess the Per nodule rates of early response (one month) after a single procedure of IRE - To assess the incidences of intra segmental/ extra segmental distant recurrence - To assess the overall survival at 1-yr following IRE procedure - To assess the respect of scheduled IRE procedure as a function of neoadjuvant phase potential SAEs - To assess the compliance to neoadjuvant and adjuvant treatments - To assess the tolerance of Durvalumab/Tremelimumab in the setting of neo- and adjuvant therapy to IRE;Primary end point(s): Local recurrence-free survival at 1-year following neoadjuvant Durvalumab/Tremelimumab and adjuvant Durvalumab therapy associated with IRE procedure in patients with BCLC A HCC;Timepoint(s) of evaluation of this end point: 1-year following neoadjuvant Durvalumab/Tremelimumab and adjuvant Durvalumab therapy associated with IRE procedure in patients with BCLC A HCC | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To assess the changes of tumorous and non-tumorous perfusion parameters observed with MRI after one months of neoadjuvant treatments - To assess the Per nodule rates of early response (one month) after a single procedure of IRE - To assess the incidences of intra segmental/ extra segmental distant recurrence - To assess the overall survival at 1-yr following IRE procedure - To assess the respect of scheduled IRE procedure as a function of neoadjuvant phase potential SAEs - To assess the compliance to neoadjuvant and adjuvant treatments - To assess the tolerance of Durvalumab/Tremelimumab in the setting of neo- and adjuvant therapy to IRE For biomarker studies: - To assess histopathological and molecular features of non-tumoral and tumor tissue after neoadjuvant phase on sequential biopsies before IRE procedure - To assess early effects of neoadjuvant Durvalumab/Tremelimumab on the tumor before IRE, judged by histology, radiology and sequential serum markers performed before AP. In particular, peripheral and histological samples will be evaluated for immunophenotyping of lymphocyte populations, circulating cytokine and chemokine assays, changes in inflammatory infiltrates and expression of immunity modulating genes. - To study changes in cytokine/chemokines profiling on sequential serum samples of patients before and after treatment as well as evaluation of sequential liquid biopsy on plasma samples;Timepoint(s) of evaluation of this end point: 1 year | — |
Countries
France
Contacts
Public ContactClinical research officer
Assistance publique - Hôpitaux de Paris
Outcome results
None listed