臨床研究等提出・公開システム

Japanese

Date of registration	Nov. 21, 2019
Last modified on	Nov. 25, 2024
Trial ID	jRCT1041190082

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

Contact for Scientific Queries	Name	Yamashita Taro
	Affiliation	Kanazawa University Hospital
	Address	13-1, Takaramachi, Kanazawa, Ishikawa
	Telephone	+81-76-265-2235
	E-mail	taroy62m@staff.kanazawa-u.ac.jp
Contact for Public Queries	Name	Terashima Takeshi
	Affiliation	Kanazawa University Hospital
	Address	13-1, Takaramachi, Kanazawa, Ishikawa
	Telephone	+81-76-265-2235
	E-mail	tera@m-kanazawa.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Nov. 21, 2019
Actual date of first enrollment		Dec. 11, 2019
Target sample size		33
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	historical control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion 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
	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
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Hepatocellular carcinoma
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
Health Condition(s) Keyword		Hepatocellular carcinoma
Intervention(s) Keyword		Sorafenib, Regorafenib
Primary Outcome(s)		1-year survival rate
Secondary Outcome(s)		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

Name of Certified Review Board	Certified Review Board, Kanazawa University
Address	13-1 Takaramachi, Kanazawa, Ishikawa
Telephone	+81-76-265-2048
E-Mail	hpsangak@adm.kanazawa-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 19, 2019

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	Nov. 25, 2024	(this page)	Changes
5	Oct. 01, 2024	Detail	Changes
4	Nov. 21, 2022	Detail	Changes
3	Dec. 18, 2021	Detail	Changes
2	Jan. 06, 2020	Detail	Changes
1	Nov. 21, 2019	Detail

List of change history