Phase II study of ramucirumab for the patients with advanced hepatocellular carcinoma previously treated with lenvatinib
Phase 2
Recruiting
- Conditions
- Hepatocellular carcinoma
- Registration Number
- JPRN-jRCT1041190083
- Lead Sponsor
- Yamashita Tatsuya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
clinically diagnosed as hepatocellular carcinoma; unsuitable for local therapy; AFP>=400ng/mL; good liver functional reserve; 20 years old or older, ECOG Performance status <=2; preservation of major organ function; written informed consent
Exclusion Criteria
refractory ascites or pleural effusion; risky varices; double cancer; metastases to central nervous system; unstable angina or myocardial infarction; severe complication; active infection; pregnant or lactating women and her partner, or women of childbearing potential; mental disorder; other factors unsuitable for participant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method Overall survival, 6-months progression free-survival rate, 1-year survival rate, Time to progression, Time to treatment failure, Overall response rate, Tumor control rate, Subsequent therapy, Relative dose intensity, Adverse event