Clinical Trial TitleA randomized, controlled phase 3 study of cabozantinib (XL184) in combination with atezolizumab versus sorafenib in subjects with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy.
Clinical Trial Protocol Description:
The purpose of this study is to find out if cabozantinib combined with atezolizumab is effective in treating liver cancer compared to sorafenib alone in people who have not received prior treatment. This study will also examine how well people with liver cancer who have not received prior treatment tolerate cabozantinib alone, and how well it works in treating their cancer.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have histological or cytological diagnosis of HCC or clinical diagnosis of HCC in cirrhotic patients by multiphase imaging using CT or MRI per the American Association for the Study of Liver Diseases (AASLD) (Marrero et al 2018) or European Association for the Study of the Liver (EASL 2018) guidelines.
- Have disease that is not amenable to a curative treatment approach (eg, transplant, surgery, ablation therapy) or locoregional therapy (eg, TACE).
- Are receiving antiviral therapy per local standard of care if you have active HBV infection (defined by HBsAg positive). You must have HBV DNA < 500 IU/mL.
- Have measurable disease per RECIST 1.1 as determined by the Investigator.
You will be excluded from the study if any of the following criteria apply to you:
- Have known fibrolamellar carcinoma, sarcomatoid HCC or mixed hepatocellular cholangiocarcinoma.
- Have had prior systemic anticancer therapy for advanced HCC including but not limited to chemotherapy, small molecule kinase inhibitors, and ICIs. Subjects who have received local intratumoral or arterial chemotherapy are eligible.
- Have documented hepatic encephalopathy (HE) within 6 months before randomization.
- Have clinically meaningful ascites (ie, ascites requiring paracentesis or escalation in diuretics) within 6 months before randomization.
This is a partial list of inclusion and exclusion criteria.