drugset / Trial / NCT03963206

Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE)

NCT03963206

Phase 4 Completed 110 enrolled Hospices Civils de Lyon
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2019-09-09
Primary completion
2021-10-07
Completion
2021-10-07

Publications

  • Results P Merle - Cabozantinib toLERANCE Study in HepatoCellular Carcinoma - Liver Cancer (Publication in progress)

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabozantinib Small molecule 20 mg
Subject Cabozantinib Small molecule 40 mg
Subject Cabozantinib Small molecule 60 mg