Hepatocellular carcinoma (HCC) is the 3rd cause of death by cancer. For patients with inoperable advanced HCC, systemic therapy with Sorafenib (Nexavar®) is the only therapeutic with proven survival benefits. However, the efficacy of Sorafenib remains inconstant and the overall incidence of treatment-related adverse event is 80%. MedDRA version: 18.1 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable System Organ Class: 100000004864
Conditions
Interventions
Trade Name: 18F-Fluorodésoxyglucose (FDG)
Product Name: GLUSCAN 600 MBq/mL®
Pharmaceutical Form: Solution for injection
Trade Name: 18F-Fluorocholine (FCH)
Product Name: IASOcholine®1 GBq/mL
Pharmac
Sponsors
Centre Georges-François Leclerc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients older than 18 years. - Inoperable (advanced or metastatic) HCC histologically proven, or diagnosed according to the Barcelona criteria, determined to be candidate for Sorafenib therapy. - Lesion(s) able to be selected as target lesion(s) for modified RECIST criteria. - Patient ineligible for curative treatment (BCLC score B or C). - Child-Pugh liver function class A. - No obvious contraindication for Sorafenib. - Adequate hematologic function (platelet count =60.109/l; hemoglobin =8.5 g/dl; INR =2.3). - ECOG status =2. - Able to lie still for 45 min for PET/CT scanning. - Able to understand and willing to sign a written informed consent document. - Affiliated to the "Sécurité Sociale" or beneficiary to such a regimen 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 87 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Uncontrolled intercurrent illness with short-term life-threatning. - Patient candidate to local/curative therapies of HCC (surgery, radiofrequency, transarterial chemoembolization, other local therapy). - Pregnant or nursing woman. - History of myocardial infarction less than 6 months before inclusion, uncontrolled hypertension, symptomatic congestive heart failure, anti-arythmic therapy (other than beta-blockers or digoxine). - History of digestive bleeding less than 30 days before inclusion. - History of liver transplantation. - Previous treatment including Sorafenib. - Uncontrolled diabetes. - History of allergic reactions attributed to compounds of similar chemical or biological composition to 18F-Fluorocholine, 18F-Fluorodeoxyglucose or Sorafenib. - Psychiatric illness/social situations that would limit compliance with the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine in a prospective multicenter study, the predictive performances on 1-year overall survival (Sensitivity, specificity, positive and negative predictive values and threshold) of lipid and glucose metabolism and perfusion changes determined with FCH and FDG PET after 4 weeks of Sorafenib therapy.;Secondary Objective: a) To determine the independent prognostic factors of overall survival. b) To identify the predictive performances and the optimal threshold of changes in FDG and FCH uptake after 4 weeks of Sorafenib therapy regarding disease control. c) To identify the predictive performances and thresholds of baseline FDG and FCH tumour uptakes regarding survival and disease control. d) To identify the best combination of metabolic parameters (FCH and FDG baseline uptake and changes) that is predictive of 1-year overall survival. e) To describe quality of life (QoL) using the EORTC QLQ-C30 (version 3.0) at each clinical surveillance visit. ;Primary end point(s): Primary end point is vital status (death or alive) ;Timepoint(s) of evaluation of this end point: one year after inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall survival - Disease Control defined by absence of radiologic progression according to modified RECIST (mRECIST) criteria (24) - Quality of life, described using the EORTC QLQ-C30 (version 3.0) ;Timepoint(s) of evaluation of this end point: - defined as survival between inclusion and death whatever the cause. - during at least 4 months following beginning of Sorafenib therapy. - Completed at inclusion and at each clinical surveillance visit. | — |
Countries
France
Contacts
Public ContactREDERSTORFF Emilie
Centre george François Leclerc
Outcome results
None listed