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Efficacy and Safety of Cabozantinib in Patients With Hepatocellular Carcinoma — Immunocabo  

Hepatocarcinoma Clinical Trial

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)

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04435977
Study type Interventional
Source Istituto Clinico Humanitas
Contact Lorenza Rimassa, MD
Phone 02 8224
Email lorenza.rimassa@humanitas.it
Status Recruiting
Phase Phase 2
Start date January 30, 2020
Completion date September 2023
View Details
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