Hepatocellular carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology Patients with cirrhosis require clinical confirmation of diagnosis based on the Clinical Practice Guidelines for Hepatocellular Carcinoma. - Disease that is not amenable to curative surgical and/or locoregional therapies - No prior systemic therapy (including non-approved and investigational agents) for HCC - ECOG Performance Status of 0 or 1 - Child-Pugh class A
Exclusion criteria
Exclusion criteria: - Fibrolamellar HCC, sarcomatoid HCC, or a mixed type of cholangiocellular carcinoma and HCC have been confirmed. - The patients who have history of hepatic encephalopathy - The patients with symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Observation | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Tumor assessment, Observation | — |
Contacts
Chugai Pharmaceutical Co., Ltd.