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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Cabozantinib

    Drug

    All patients will be treated with cabozantinib at 60 mg once daily.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: CabozantinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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 .

Time frame
30 months
2

Treatment-emergent adverse event

Incidence of treatment-emergent adverse events

Time frame
30 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: