Hepatocellular carcinoma (HCC) is a common tumor (the 8th leading cause of cancer in France) and has a poor prognosis. It is the 3rd leading cause of cancer deaths in the world. In the early stages (low tumor mass), HCC can be treated for curative purposes by surgical resection, percutaneous ablation or liver transplantation. When the tumor mass is larger (\> 3 nodules) but remains confined to the liver, the standard treatment is hepatic intra-arterial chemoembolization (TACE). In the event of failure of the latter or if the tumor dissemination progresses in the portal venous system or in the form of metastases, the systemic treatments are then indicated. In 1st line, the reference treatment is a tyrosine kinase inhibitor (ITK) Sorafenib. Cabozantinib obtained the European and French authorization (AMM) in November 2018 for its use in case of failure of Sorafenib in patients with HCC. The main objective is the evaluation of the safety of Cabozantinib administered to patients with intermediate HCC ineligible for chemoembolization or advanced HCC after failure of Sorafenib and possibly another systemic anticancer line.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
The patient starts at 60 mg / day at a distance from meals In the event of intolerance to this dose of 60 mg; specific adapted measures will be taken according to the recommendations of the good practices of use of Cabozantinib within the framework of its MA. If the symptomatic treatments are not enough, each investigator can adapt the dose of Cabozantinib reducing it to 40 or even 20 mg / day Cabozantinib will be continued for as long as radiological and / or clinical benefit is observed for the patient (no progression of the disease) or until the occurrence of unacceptable toxicity.
CHU Amiens Picardie - Hôpital Sud
Amiens, France
CHU Jean Minjoz
Besançon, France
Hôpital Avicenne
Bobigny, France
Centre Hospitalier de Boulogne sur mer
Boulogne-sur-Mer, France
Centre hospitalier universitaire Côte de nacre
Caen, France
Hôpital Beaujon
Clichy, France
CHRU de Lille-Hôpital Claude Huriez
Lille, France
CHU Dupuytren
Limoges, France
Hospices Civils de Lyon - Hôpital de la Croix Rousse
Lyon, France
APHM - Timone
Marseille, France
...and 8 more locations
survival of the patient after start of treatment
Overall Survival (OS) defined as the time (in months) between the start of treatment with Cabozantinib and the date of death from all causes; patients who are alive or lost to follow-up at the time of the analysis will be censored on the last follow-up date
Time frame: Year 1
dosage modification for adverse effect
Incidence of changes in the dose of Cabozantinib for adverse effect during treatment (including daily dose reductions, dose spacings, discontinuation and permanent cessation of treatment for intolerance).
Time frame: Year 1
Daily median dose of Cabozantinib
Daily median dose of Cabozantinib calculated between the start of treatment with Cabozantinib and the day of final cessation (including death)
Time frame: Year 1
Number of patients with each dose of Cabozantinib
calculation of the number of patients with a dose of Cabozantinib 60 mg, 40 mg or 20 mg at the end of treatment or at the end of the study.
Time frame: Year1
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