Phase II study of sorafenib-regorafneib sequential therapy for the patients with advanced hepatocellular carcinoma previously treated with lenvatinib

JRCT ID: jRCT1041190082

Registered date:21/11/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 11/12/2019
• Target sample size: 33
• Study type: Interventional
• Intervention(s): 160 mg of oral regorafenib during weeks 1 to 3 of each 4 week cycle after 400 mg of sorafenib orally twice daily

Outcome(s)

• Primary Outcome: 1-year survival rate
• Secondary Outcome: Progression-free survival, Overall survival, 6-months progression free-survival rate, Time to progression, Time to treatment failure, Overall response rate, Tumor control rate, Subsequent therapy, Adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: clinically diagnosed as hepatocellular carcinoma; unsuitable for local therapy; good liver functional reserve; 20 years old or older, ECOG Performance status <=2; preservation of major organ function; written informed consent
• Exclude 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

Related Information

• Primary Sponsor: Yamashita Tatsuya