Cabozantinib for Progressive HCC Post-first-line Immuno-oncologic Combination Therapy

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Health Research Institutes, Taiwan

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

Qualifiers

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

Treatments tested in this trial

  • Cabozantinib

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators

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