Efficacy and tolerability of ABT-869 Versus Sorafenib in Advanced hepatocellular carcinoma(HCC)
Phase 3
- Conditions
- advanced or metastatic HCC
- Registration Number
- JPRN-jRCT2080221053
- Lead Sponsor
- Abbott Japan Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 900
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival
- Secondary Outcome Measures
Name Time Method Time to progression (TTP) <br>Objective response rate (ORR)