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.
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
• 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.
Single group
Cabozantinib
DrugCabozantinib (Cabometyx) 60, 40 and 20 mg
Disease control rate (DCR) per RECIST 1.1 at 4th month
Proportion of participants with stable disease, partial response and complete response at 4th month of cabozantinib treatment based on RECIST 1.1
Objective response rate (ORR) per RECIST 1.1 at 4th month
Proportion of participants with partial response or complete response at 4th month of treatment based on RECIST 1.1
Progression-free survival (PFS) per RECIST 1.1
Time from treatment initiation to documented disease progression per RECIST 1.1 or death
Overall survival (OS)
Time from treatment initiation to patient death
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Chulalongkorn University
Lead sponsor
Mahidol University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
