About this trial
1. To investigate the efficacy and safety of cabozantinib in patients with progressive HCC after ICI-based combination treatment. 2. To explore potential tissue and peripheral blood biomarkers associated with clinical benefits of cabozantinib, and resistance mechanisms of prior ICI and cabozantinib.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Understood and signed the informed consent form
Ability to comply with all protocol requirements
Age ≥ 18 years when signing informed consent form
Diagnosis of HCC confirmed by histology
Disqualifiers
Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
Prior cabozantinib treatment
Any systemic anti-cancer therapy administered after discontinuation of the first-line immune checkpoint inhibitor-based combination
Prior liver-directed locoregional therapy administered within 4 weeks before registration
Trial design
Single group
Treatments tested in this trial
Cabozantinib
DrugAll patients will be treated with cabozantinib at 60 mg once daily.
Treatment groups
Trial outcomes
Primary outcomes
Progression-free rate at 6 months
The percentage of subjects remaining progression (per RECIST v1.1) -free at 6 months after initiation of study treament .
Treatment-emergent adverse event
Incidence of treatment-emergent adverse events
Sponsors and contacts
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National Health Research Institutes, Taiwan
Lead sponsor
National Taiwan University Hospital
Collaborator
Taipei Veterans General Hospital, Taiwan
Collaborator
Tri-Service General Hospital
Collaborator
Mackay Memorial Hospital
Collaborator
Chang Gung Memorial Hospital
Collaborator
China Medical University Hospital
Collaborator
Taichung Veterans General Hospital
Collaborator
National Cheng-Kung University Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options: