LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Aged >18 years at time of informed consent - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 - HCC that has been histologically confirmed
Exclusion criteria
Exclusion criteria: - Previous or concomitant autoimmune disease - Uncontrolled diabetes mellitus and hypertension - Concurrent New York Heart Association (NYHA) Class >II congestive heart failure, myocardial infarction, arrhythmia, or unstable angina, or a history thereof within 6 months before enrollment. - Concurrent symptomatic cerebrovascular disorder (e.g., subarachnoid hemorrhage, cerebral infarction, or transient ischemic attack), or a history thereof within 6 months before enrollment. - Symptomatic, untreated, or actively progressing CNS metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety NCI CTCAE | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy RECIST | — |
Countries
HongKong, Japan, Singapore, Taiwan
Contacts
Chugai Pharmaceutical Co., Ltd.