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 |
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Health condition(s) or Problem(s) studied | Hepatocellular carcinoma |
Date of first enrollment | 11/12/2019 |
Target sample size | 33 |
Countries of recruitment | |
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 |
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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 |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Takeshi Terashima |
Address | 13-1, Takaramachi, Kanazawa, Ishikawa Ishikawa Japan 920-8641 |
Telephone | +81-76-265-2235 |
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 |
ytatsuya@m-kanazawa.jp | |
Affiliation | Kanazawa University Hospital |