Palliative Treatment of Hepatocellular Carcinoma in Patient With CHILD B Cirrhosis

• Status: Completed
• Trial end date: 2017-04-12
• Target enrollment: 0
• Participant gender: All

Summary

The incidence of Hepatocellular Carcinoma (HCC) is currently increasing in Europe and in France and about 2 / 3 of patients, are not eligible for curative treatment at the time of diagnosis. The palliative management of patients with advanced and symptomatic disease is complex and requires treatment combining anti-tumor activity and safety in patients with impaired liver functions. Sorafenib is the standard of care in a palliative setting, but the benefit of sorafenib in patient with altered liver function is uncertain. The aim of this trial is to study the interest of sorafenib in patients with HCC and impaired liver function compared to pravastatin (a drug with anti-tumoral activity in HCC) or to the combination sorafenib/pravastatin or to best supportive care (usually used in these patients).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Collaborators: Federation Francophone de Cancerologie Digestive; UNICANCER
• Treatments: Niacinamide; Pravastatin; Sorafenib

Criteria

Inclusion Criteria:

• Male and female subjects > 18 years age

• Hepatocellular carcinoma histologically diagnosed or in case of inability to perform a histology by non invasive radiological criteria in presence of known cirrhosis: (i) Hepatic lesion measuring between 1 and 2 cm in diameter : CT-scan + MRI (eventually an Ultrasound contrast) : HCC diagnosed with contrast uptake in the arterial phase and rapid wash out in the venous /late phase on two imaging techniques.

(ii)Hepatic lesion with a diameter > 2 cm : CT-scan or MRI +alpha fetoprotein : HCC diagnosed with contrast uptake in the arterial phase and a rapid wash out in the venous /late phase or a alpha fetoprotein > 200µg/L

• Patient not eligible for curative treatment (transplantation, resection, destruction or percutaneous chemo-embolization) or HCC still evolving after failure of a specific treatment

• Score CHILD B

• ECOG performance status 0/1/2

• Score BCLC B or C

• Adequate haematologic function with haemoglobin > 8 g/dl, platelet count > 50000x 109/L, absolute neutrophil count > 1000 / mm3

• Creatinine < 2 times the upper limit of normal

• Written informed consent

Exclusion Criteria:

• Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study

• Pregnancy

• Myocardial infarction less than 6 months, uncontrolled hypertension, congestive heart failure(NYHA class > 2) , anti- arrhythmic treatment other than beta-blockers or digoxin

• Digestive bleeding within 30 days before inclusion

• Hepatic transplantation

• Patients receiving or having received a statine for less than 6 months before HCC diagnostic

• Prior use of sorafenib

• Psychiatric illness/social situations that would limit compliance with study requirements.

• Previous or concurrent cancer, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumor. Any cancer curatively treated > 5 years prior to entry is permitted

• Known or suspected history of allergy to sorafenib or pravastatin.