臨床研究等提出・公開システム

Date of registration	July. 09, 2015
Last modified on	Oct. 11, 2021
Trial ID	jRCT2080222910

Scientific Title	-
Public Title	-

Completion Date or Terminated date	July. 23, 2021
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	Yes
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number	-
	E-mail Address	JPCT@msd.com

Contact for Public Queries	Name
	Contact Name for Public Queries
	Address
	Phone Number	-
	E-mail Address	JPCT@msd.com

Recruitment Status	completed

Date of First Enrolment		April. 07, 2015
Target Sample Size		253
Study Type		Interventional
Study Design	Study Design
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria
	Exclusion Criteria
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied
Intervention(s)		investigational material(s) Generic name etc : INN of investigational material : Pembrolizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Generic name etc : INN of investigational material : Pembrolizumab, Cisplatin, Fluorouracil Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : Generic name etc : INN of investigational material : Pembrolizumab, Capecitabine Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : Generic name etc : INN of investigational material : Pembrolizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : control material(s) Generic name etc : INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material :
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety safety efficacy
Secondary Outcome

Primary Sponsor
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB	2018/3/26通知発出前に治験届提出の試験（古い試験のため、IRBの掲載許可なし）
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Feb. 23, 2015

Secondary ID No.	NCT0233541
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-152962
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan/North America/South America/Europe/Oceania

History of Changes

No	Publication date
4	Oct. 11, 2021	(this page)	Changes
3	Aug. 08, 2016	Detail	Changes
2	Dec. 08, 2015	Detail	Changes
1	July. 09, 2015	Detail

List of change history