UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030850
Receipt number R000035224
Scientific Title An observational study to discover novel biomarkers for nivolumab in patients with advanced gastric cancer (DELIVER trial): JACCRO GC-08
Date of disclosure of the study information 2018/01/17
Last modified on 2020/07/21 10:04:15

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Basic information

Public title

An observational study to discover novel biomarkers for nivolumab in patients with advanced gastric cancer (DELIVER trial): JACCRO GC-08

Acronym

An observational/translational study for nivolumab in gastric cancer (DELIVER trial): JACCRO GC-08

Scientific Title

An observational study to discover novel biomarkers for nivolumab in patients with advanced gastric cancer (DELIVER trial): JACCRO GC-08

Scientific Title:Acronym

An observational/translational study for nivolumab in gastric cancer (DELIVER trial): JACCRO GC-08

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

The purpose of this study is to evaluate efficacy and safety of nivolumab treatment for advanced gastric cancer in clinical practice. The translational study also is performed to identify the predictive factors for efficacy or toxicity of nivolumab by analyzing gut microbiome, genetic polymorphism, gene expression, and metabolome in plasma before and after treatment.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Overall Survival

Key secondary outcomes

Response Rate, Disease Control Rate, Depth of Response, Tumor Shrinkage Rate, Tumor Progression Rate, Progression-Free Survival, Safety, Biomarker Analysis


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) Patients with histologically confirmed diagnosis of adenocarcinoma of the GEJ/gastric cancer.
(2) Patients treated with nivolumab alone treatment (in any lines).
(3) ECOG performance status 0-2.
(4) 20 years of age or more.
(5) Patients with potential to collect feces and blood before and after nivolumab treatment.
(6) Written informed consent.

Key exclusion criteria

(1) Patients previously treated with nivolumab
(2) HBs antigen-positive or HCV antibody-positive
(3) Patients who are regarded as inadequate for study enrollment by investigators.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Yu
Middle name
Last name Sunakawa

Organization

St. Marianna University School of Medicine

Division name

Department of Clinical Oncology

Zip code

216-8511

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan

TEL

044-977-8111

Email

y.sunakawa@marianna-u.ac.jp


Public contact

Name of contact person

1st name Masashi
Middle name
Last name Fujii

Organization

Japan Clinical Cancer Research Organization (JACCRO)

Division name

Office

Zip code

104-0061

Address

1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan

TEL

03-5579-9882

Homepage URL


Email

gc08.dc@jaccro.or.jp


Sponsor or person

Institute

Japan Clinical Cancer Research Organization (JACCRO)

Institute

Department

Personal name



Funding Source

Organization

ONO PHARMACEUTICAL CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

DNA Chip Research Inc.

Name of secondary funder(s)

Bristol-Myers Squibb Co. Ltd.


IRB Contact (For public release)

Organization

Japan Clinical Cancer Research Organization Institutional Review Board

Address

7F Ginza Wing Bil.,1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan

Tel

03-5579-9882

Email

jaccro@jaccro.or.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

聖マリアンナ医科大学(神奈川県)他


Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 17 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

501

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

No longer recruiting

Date of protocol fixation

2018 Year 01 Month 15 Day

Date of IRB

2018 Year 01 Month 15 Day

Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date

2022 Year 08 Month 31 Day

Date of closure to data entry

2022 Year 08 Month 31 Day

Date trial data considered complete

2022 Year 12 Month 31 Day

Date analysis concluded

2023 Year 03 Month 31 Day


Other

Other related information

prospective observational study.
We research about patient backgrounds, treatment, safety and efficacy.


Management information

Registered date

2018 Year 01 Month 17 Day

Last modified on

2020 Year 07 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035224


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name