Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE) (CLERANCE)
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|ClinicalTrials.gov Identifier: NCT03963206|
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Cabozantinib group Other: ECG||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CLERANCE HCC, Cabozantinib toLERANCE Study in HepatoCellular Carcinoma|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
patients will receive Cabozantinib (within the framework of its MA) (an ECG is added)
Drug: Cabozantinib group
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.
ECG between day -27 / day 0 (if significant, it will be done every visit)
- survival of the patient after start of treatment [ Time Frame: Year 1 ]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
- dosage modification for adverse effect [ Time Frame: Year 1 ]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).
- Daily median dose of Cabozantinib [ Time Frame: Year 1 ]Daily median dose of Cabozantinib calculated between the start of treatment with Cabozantinib and the day of final cessation (including death)
- Number of patients with each dose of Cabozantinib [ Time Frame: Year1 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963206
|Contact: Philippe Merle, Pr||+33 4 26 10 94 firstname.lastname@example.org|
|Hospices Civils de Lyon - Hôpital de la Croix Rousse||Not yet recruiting|
|Lyon, France, 69004|
|Contact: Philippe MERLE, Pr +33 4 26 10 94 37 email@example.com|
|Principal Investigator: Philippe MERLE|