NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1041190082

Registered date:21/11/2019

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedHepatocellular carcinoma
Date of first enrollment11/12/2019
Target sample size33
Countries of recruitment
Study typeInterventional
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 Outcome1-year survival rate
Secondary OutcomeProgression-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 maximumNot applicable
GenderBoth
Include criteriaclinically 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 criteriarefractory 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

Contact

Public contact
Name Takeshi Terashima
Address 13-1, Takaramachi, Kanazawa, Ishikawa Ishikawa Japan 920-8641
Telephone +81-76-265-2235
E-mail tera@m-kanazawa.jp
Affiliation Kanazawa University Hospital
Scientific contact
Name Tatsuya Yamashita
Address 13-1, Takaramachi, Kanazawa, Ishikawa Ishikawa Japan 920-8641
Telephone +81-76-265-2235
E-mail ytatsuya@m-kanazawa.jp
Affiliation Kanazawa University Hospital