UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032164
Receipt No. R000036689
Scientific Title A study of biomarker predicting the effect of Nivolumab for unresectable advanced or recurrent gastric cancer.
Date of disclosure of the study information 2018/04/09
Last modified on 2018/04/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A study of biomarker predicting the effect of Nivolumab for unresectable advanced or recurrent gastric cancer.
Acronym Biomarker research of Nivolumab for gastic cancer.
Scientific Title A study of biomarker predicting the effect of Nivolumab for unresectable advanced or recurrent gastric cancer.
Scientific Title:Acronym Biomarker research of Nivolumab for gastic cancer.
Region
Japan

Condition
Condition Unresectable advanced or recurrent gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To search predictive biomarker of Nivolumab treatment for unresectable advanced or recurrent gastric cancer by immunohistochemical examination.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Association between overall survival (OS) and the protein expression of each factor.
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 over 20 years old.
2) Histologically diagnosed unresectable advanced or recurrent gastric or esophagogastric junction adenocarcinoma.
3) Tumor tissues for biomarker examination are available.
4) Treatment with more than 2 regimens is provided for unresectable advanced or recurrent gastric or esophagogastric cancer.
5) Nivolumab treatment is planning to go, is going, or was performed as a treatment with later than third rejimens.
6) Written informed consent.
Key exclusion criteria 1) Synchronous or metachronous (within 5 years) double cancers, except for intraepithelial tumor (Carcinoma in situ) or intramucosal tumor curatively resectable by local therapy at the time of Nivolumab treatment.
2) History of medical therapy for the purpose of the immune checkpoint inhibitors such as antiPD-1 antibody, antiPD-L1 antibody, antiCTLA-4 antibody or other T cell regulator before the Nivolumab treatment.
3) Having severe psychological illness and difficult to make a judgement for participation in the study.
4) Judged to be unfit to participate in the study by investigater.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichiro Doki
Organization Graduated School of Medicine, Osaka University
Division name Department of Gastroenterological Surgery
Zip code
Address 2-2-E2, Yamadaoka, Suita City, Osaka
TEL 06-6879-3251
Email ydoki@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukinori Kurokawa
Organization Graduated School of Medicine, Osaka University
Division name Department of Gastroenterological Surgery
Zip code
Address 2-2-E2, Yamadaoka, Suita City, Osaka
TEL 06-6879-3251
Homepage URL
Email ykurokawa@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 04 Month 09 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 Open public recruiting
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2018 Year 04 Month 09 Day
Last modified on
2018 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036689

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.