advanced or metastatic HCC
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Histologic or cytologic diagnosis with unresectable or metastatic HCC - Child Pugh Class A - ECOG performance status 0-1 - Adequate hematologic, hepatic, and renal function
Exclusion criteria
Exclusion criteria: - Prior systemic (administered intravenously or orally rather than locoregionally) treatment for HCC. - Prior local therapy (including liver-directed therapy) within 4 weeks from entry - Untreated brain or meningeal metastases - Current treatment on another clinical trial - Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression (TTP) Objective response rate (ORR) | — |