Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE)

Sponsor
Hospices Civils de Lyon
Study ID
NCT03963206
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib group — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 9, 2019
Status verified
Nov 2025
Primary completion
Oct 7, 2021
Completion
Oct 7, 2021

Study Design

Enrollment
110 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Cabozantinib group
    patients will receive Cabozantinib (within the framework of its MA) (an ECG is added)

Primary Outcome Measure

survival of the patient after start of treatment [ Time Frame: Year 1 ]

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