PREMETHEP : Multimetabolic 18F-Fluorodeoxyglucose (FDG) and 18F-Fluorocholine (FCH) Positron Emission Tomography (PET) as an early predictive factor of overall survival in patients with advanced hepatocellular carcinoma treated with sorafenib.
- Conditions
- 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: 18.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-004108-44-FR
- Lead Sponsor
- Centre Georges-François Leclerc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 87
- 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
- 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.
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