臨床研究等提出・公開システム

Date of registration	Mar. 01, 2021
Last modified on	June. 01, 2022
Trial ID	jRCT1031200386

Scientific Title	Exploratory study for stratification marker of immune check point inhibitor in patients with advanced or recurrent gastric or esophageal cancer
Public Title	Stratification marker for immunotherapy in gastric or esphageal cancer

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	tsasada@kcch.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	tsasada@kcch.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 01, 2021
Actual date of first enrollment		April. 28, 2021
Target sample size		150
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients with pathologically or cytologically diagnosed, advanced or recurrent, gastric or esphageal cancer, who are treated with anti-PD-1/PL-L1 antibody (measurable target lesions for response evaluation are not required). 2) Patients over 20 years old with written informed consent 3) Patients with ECOG PS 0-2
	Exclusion Criteria	1) Patients with the past history of immunological treatments (immune checkpoint inhibitors, cancer vaccines, or immune cell therapies) 2) Patients with regular use of amino acid formulations (asintravenous or enteral nutrition) or supplements 3) Patients with presumed abnormalities of amino acid metabolism, such as liver cirrhosis, renal failure, inborn error of amino acid metabolism, pregnancy, and feeding 4) Patients enrolled in other clinical trials for pharmaceuticals or medical devices 5) Patients with active double cancer [synchronic double cancer or asynchronous double cancer with no more than 5-year disease-free period, excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured by local treatment] 6) Patients with other inappropriate conditions for enrollment judged by the clinicians
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		gastric cancer, esophageal cancer
Primary Outcome(s)		Multivariate discriminant models created by combination of plasma amino acid and/or metabolite concentrations, which are useful for predicting overall survival in patients treated with anti-PD-1/PL-L1 antibody
Secondary Outcome(s)		Multivariate discriminant models created by combination of plasma amino acid and/or metabolite concentrations, which are useful for predicting progression free survival in patients treated with anti-PD-1/PL-L1 antibody

Primary Sponsor	Kanagawa Cancer Center

Secondary Sponsor

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Name of Certified Review Board	Kanagawa Cancer Center Ethics Review Committee
Address	2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa
Telephone	+81-45-520-2222
Approval Status	Approval
Date of approval	Feb. 08, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	June. 01, 2022	(this page)	Changes
3	Feb. 15, 2022	Detail	Changes
2	Sept. 07, 2021	Detail	Changes
1	Mar. 01, 2021	Detail

List of change history