臨床研究等提出・公開システム

Date of registration	Sept. 05, 2024
Last modified on	Mar. 19, 2025
Trial ID	jRCT1031240320

Scientific Title	Exploratory study of biomarkers associated with "Phase III study of gemcitabine, cisplatin plus S-1 combination therapy versus gemcitabine, cisplatin plus immune checkpoint inhibitor combination therapy in advanced biliary tract cancer" (Biomarker study for YOTSUBA trial)
Public Title	Exploratory study of biomarkers associated with "Phase III study of gemcitabine, cisplatin plus S-1 combination therapy versus gemcitabine, cisplatin plus immune checkpoint inhibitor combination therapy in advanced biliary tract cancer" (Biomarker study for YOTSUBA trial)

Contact for Scientific Queries	Name	Sasada Tetsuro
	Affiliation	Kanagawa Cancer Center
	Address	2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa 241-8515, Japan
	Telephone	+81-45-520-2222
	E-mail	sasada.0980e@kanagawa-pho.jp
Contact for Public Queries	Name	Sasada Tetsuro
	Affiliation	Kanagawa Cancer Center
	Address	2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa 241-8515, Japan
	Telephone	+81-45-520-2222
	E-mail	sasada.0980e@kanagawa-pho.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 01, 2024
Actual date of first enrollment		Aug. 26, 2024
Target sample size		170
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Biliary tract cancer patients enrolled in "Phase III study of gemcitabine, cisplatin plus S-1 combination therapy versus gemcitabine, cisplatin plus immune checkpoint inhibitor combination therapy in advanced biliary tract cancer" (KHBO-2201)
	Exclusion Criteria	1) History of immunotherapy (anti-PD-1/PD-L1 antibody therapy, anti-CTLA-4 antibody therapy, cancer vaccine therapy, immune cell therapy, etc.). 2) Regular use of amino acid preparations (intravenous nutrition, enteral component nutrition, etc.) or amino acid supplements (concomitant use of anamorelin hydrochloride is acceptable). 3) Presumed abnormalities of amino acid metabolism (cirrhosis, renal failure, congenital abnormalities of amino acid metabolism, etc.).
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		biliary tract cancer
Health Condition(s) Code		D001661
Primary Outcome(s)		Creation of a multivariate discriminant model by combination of plasma amino acid concentrations to predict overall survival in advanced biliary tract cancer patients treated with gemcitabine/cisplatin/S-1 combination therapy and gemcitabine/cisplatin/immune checkpoint inhibitor combination therapy.
Secondary Outcome(s)		Creation of a multivariate discriminant model by combination of plasma amino acid concentrations to predict progression-free survival in advanced biliary tract cancer patients treated with gemcitabine/cisplatin/S-1 combination therapy and gemcitabine/cisplatin/immune checkpoint inhibitor combination therapy.

Primary Sponsor	Kanagawa Cancer Center

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Kanagawa Cancer Center Institutional Review Board
Address	2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa 241-8515, Japan, Kanagawa
Telephone	+81-45-520-2222
Approval Status	Approval
Date of approval	July. 01, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Mar. 19, 2025	(this page)	Changes
1	Sept. 05, 2024	Detail

List of change history