A Phase 2, Single Arm Study of Cabozantinib in Patients With Hepatocellular Carcinoma Who Have Received Prior Atezolizumab and Bevacizumab

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChulalongkorn University

About this trial

Hepatocellular carcinoma (HCC) is the most common liver cancer and a leading cancer death worldwide. Currently, atezolizumab and bevacizumab combination is the standard of care for patients with advanced HCC. There have not been proven therapy for patients with advanced HCC previously treated with atezolizumab and bevacizumab. Cabozantinib is a proven therapy for patients with advanced HCC previously treated with sorafenib. The study aims to demonstrate the efficacy and safety of cabozantinib in patients with advanced previously treated with atezolziumab and bevacizumab. It is a multi-center single-arm study which all participants will receive cabozantinib. Participants will continue cabozantinib until. disease progression or unacceptable toxicities.

Eligibility criteria

Qualifiers

Radiological, histological or cytological diagnosis of HCC

The subject has disease that is not amenable to a curative treatment approach (eg, transplant, surgery, radiofrequency ablation)

Received prior atezolizumab and bevacizumab

Progression following atezolizumab and bevacizumab treatment for advanced HCC

Disqualifiers

• Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma

Receipt of more than one prior systemic therapy for advanced HCC. Additional prior systemic therapies used as adjuvant or local therapy are allowed.

Any type of anticancer agent (including investigational) within 2 weeks before enrollment

Radiation therapy within 4 weeks (2 weeks for radiation for bone metastases) or radionuclide treatment (eg, I-131 or Y-90) within 6 weeks of enrollment. Subject is excluded if there are any clinically relevant ongoing complications from prior radiation therapy.

Trial design

Treatments tested in this trial

  • Cabozantinib

Treatment groups

40 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Chulalongkorn University

Lead sponsor

Mahidol University

Collaborator