UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective observational study of monotherapy outcomes on the efficacy of third-line or later treatment for patients with HER2 positive unresectable recurrent or metastatic gastric cancer previously treated with trastuzumab
Acronym	A retrospective observational study of monotherapy outcomes on the efficacy of third-line or later treatment for patients with HER2 positive unresectable recurrent or metastatic gastric cancer previously treated with trastuzumab
Scientific Title	A retrospective observational study of monotherapy outcomes on the efficacy of third-line or later treatment for patients with HER2 positive unresectable recurrent or metastatic gastric cancer previously treated with trastuzumab
Scientific Title:Acronym	A retrospective observational study of monotherapy outcomes on the efficacy of third-line or later treatment for patients with HER2 positive unresectable recurrent or metastatic gastric cancer previously treated with trastuzumab
Region	Japan

Condition
Condition	HER2 positive unresectable recurrent or metastatic gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the treatment efficacy of single-agent treatment (nivolumab [Nivo], irinotecan [CPT-11], and trifluridine tipiracil [FTD/TPI]) as third line or later for patients with HER2 positive gastric cancer previously treated with trastuzumab (T-mab).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival, Real world, Progression-free survival, Duration of response, Time to treatment failure, Objective response rate, Disease control rate
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Age 20 years or older, at the start of administration 2) Patients diagnosed as HER2 positive gastric cancer by pathological examination in their charts 3) Patients diagnosed with unresectable advanced or recurrent gastric cancer 4) Patients previously treated with T-mab 5) Patients who have started treatment with either Nivo, CPT-11 or FTD/TPI as a single agent in the third-line or later treatment between September 22, 2017 (date to be approved the expanded indication of Nivo for gastric cancer in Japan) and March 31, 2020.
Key exclusion criteria	1) Patients who declined this study before database lock
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yuichiro Middle name Last name Doki
Organization	Graduate school of Medicine OSAKA University
Division name	Department of Gastroenterological Surgery
Zip code	565-0871
Address	2-15 Yamadaoka, Suita, Osaka 565-0871
TEL	06-6210-8318
Email	dsakai@cfs.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Sakai
Organization	Graduate school of Medicine OSAKA University
Division name	Department of Frontier Science for Cancer and Chemotherapy
Zip code	565-0871
Address	2-15 Yamadaoka, Suita, Osaka 565-0871
TEL	06-6210-8318
Homepage URL
Email	dsakai@cfs.med.osaka-u.ac.jp

Sponsor
Institute	Graduate school of Medicine OSAKA UniversityDepartment of Gastroenterological Surgery
Institute
Department

Funding Source
Organization	DAIICHI SANKYO CO.,LTD. Oncology medical science departmen
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University Clinical Research Review Committee
Address	2-15 Yamadaoka, Suita, Osaka 565-0871
Tel	06-6879-5111
Email	dsakai@cfs.med.osaka-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 04 Month 23 Day
Date of IRB	2020 Year 08 Month 06 Day
Anticipated trial start date	2020 Year 08 Month 06 Day
Last follow-up date	2020 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	-

Management information
Registered date	2020 Year 06 Month 22 Day
Last modified on	2021 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046480