Spots Global Cancer Trial Database for Efficacy and Safety of Cabozantinib in Patients With Hepatocellular Carcinoma

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Trial Identification

Brief Title: Efficacy and Safety of Cabozantinib in Patients With Hepatocellular Carcinoma

Official Title: Efficacy and Safety of Cabozantinib in Patients With Hepatocellular Carcinoma Progressing on or Intolerant to Prior Treatment With Immune Checkpoint Inhibitors: A Phase II Study (Immunocabo)

Study ID: NCT04435977

Conditions

Hepatocarcinoma

Interventions

Cabozantinib 60 MG

Study Description

Brief Summary: This is an open-label, single-center, Phase II trial designed to estimate in terms of PFS the efficacy of cabozantinib, given as second- or third- line treatment in HCC patients that progress on or are intolerant to immune checkpoint inhibitors, including anti-PD-1 and anti-PD-L1 antibodies.

Detailed Description: Subjects who meet all study eligibility criteria will take tablets containing 60 mg of cabozantinib once daily orally. Required dose reductions will be in decrements of 20 mg cabozantinib (maximum two dose reductions). Subjects will receive study treatment as long as they continue to experience clinical benefit in the opinion of the investigator or until there is unacceptable toxicity. Primary objective of this study is to evaluate the efficacy of cabozantinib, given as second- or third-line treatment in HCC patients that progress on or are intolerant to immune checkpoint inhibitors. Secondary objectives for this study are as follows: * To evaluate the activity of cabozantinib, in terms of ORR (CR+PR) as per RECIST 1.1, duration of response, time to treatment failure (TTF), time to progression (TTP), and OS * To evaluate the safety and tolerability of cabozantinib