臨床研究等提出・公開システム

Date of registration	Nov. 15, 2023
Last modified on	Aug. 21, 2025
Trial ID	jRCTs061230077

Scientific Title	Efficacy of butyric Acid preparations in patients with unresectable hepatocellular carcinoma underGoing systEmic chemotheRapy (EAGER study)
Public Title	Efficacy of butyric acid preparations in patients with hepatocellular carcinoma undergoing chemotherapy

Contact for Scientific Queries	Name	Otsuka Motoyuki
	Affiliation	Okayama University Hospital
	Address	2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama
	Telephone	+81-86-235-7219
	E-mail	otsukamoto@okayama-u.ac.jp
Contact for Public Queries	Name	Sue Masahiko
	Affiliation	Okayama University Hospital
	Address	2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama
	Telephone	+81-86-235-7219
	E-mail	p58q0soo@okayama-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Nov. 15, 2023
Actual date of first enrollment		April. 24, 2024
Target sample size		25
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1 18 age old over 2 Regardless of gender 3 Patients diagnosed with unresectable hepatocellular carcinoma 4 Patients who will receive treatment with Durvalumab and Tremelimumab 5 Patients who have been fully informed consent
	Exclusion Criteria	1 Patients with Child-Pugh score over 8 2 Patients used to have hypersensitivity with butyric acid 3 Being pregnant or possibly pregnant 4 Patients who judged as inappropriate candidate by the chief medical examine
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Unresectable hepatocellular carcinoma
Intervention(s)		Patients with unresectable hepatocellular carcinoma will receive MiyaBM granule orally at a dose of 1.5g or MiyaBM 3 tablets per day. This will be administered until progress of tumor(assume average of 12 months).
Health Condition(s) Keyword		Unresectable HCC
Primary Outcome(s)		progression free survival
Secondary Outcome(s)		1 Response rate 2 Disease cotrol rate 3 Overall survival 4 Change of intestinal flora 5 Adverse Events and side effects

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Okayama University Certified Review Board
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
Telephone	+81-86-235-7133
E-Mail	ouh-crrb@adm.okayama-u.ac.jp
Approval Status	Approval
Date of approval	Aug. 22, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Aug. 21, 2025	(this page)	Changes
2	Jan. 09, 2025	Detail	Changes
1	Nov. 15, 2023	Detail

List of change history