UMIN-CTR Clinical Trial

Public title

A multicenter prospective observational study to explore biomarkers of anti PD-1 antibody therapy for gastric cancer

Acronym

A multicenter prospective observational study to explore biomarkers of anti PD-1 antibody therapy for gastric cancer

Scientific Title

A multicenter prospective observational study to explore biomarkers of anti PD-1 antibody therapy for gastric cancer

Scientific Title:Acronym

A multicenter prospective observational study to explore biomarkers of anti PD-1 antibody therapy for gastric cancer

Region

Japan

Condition

Gastric cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To identify blood biomarkers useful for predicting the efficacy and occurrence of adverse events when using anti-PD-1 antibodies for gastric cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

none

Key secondary outcomes

Relationship between metabolite (amino acids and lipid metabolites etc.),and cytokines in blood samples before treatment and
1)Progression free survival, overall survival, and response rate of anti-PD-1 antibody and its subsequent chemotherapy,
2)immune related adverse event

Correlation between each biomarker.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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 time of registration.
2) Advanced unresectable or recurrent gastric cancer (including junctional cancer) with histologically confirmed adenocarcinoma.
(3) ECOG performance status 0 to 2.
(4) Patients must be planned to treat with anti-PD-1 antibody (any line of treatment is acceptable).
5) Patients must have evaluable lesions on contrast-enhanced CT/MRI within 28 days prior to enrollment (measurable lesions are not required).
*Simple CT/MRI is acceptable if CT contrast agent is difficult to use due to contrast agent allergy or renal dysfunction.
6) Availability of fasting blood samples for biomarker research.
7) No prior therapy with anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, or other T-cell modulating drugs prior to enrollment.
8) No systemic corticosteroids equivalent to prednisolone exceeding 10 mg/day (except for temporary use for testing or prophylactic administration) or immunosuppressive agents within 14 days prior to enrollment.
9) Written consent for participation in the study has been obtained from the patient.

Key exclusion criteria

(1) Patients with active multiple cancers (concurrent multiple cancers/multiple cancers and heterogeneous multiple cancers/multiple cancers with disease-free interval of 3 years or less. (However, if the cancer is not a prognostic factor for the patient, it is not excluded.)
(2) Patients with psychosis or psychiatric symptoms that interfere with daily life, making it difficult to participate in the study.
3) Other conditions deemed inappropriate by the physician in charge.

Target sample size

50

Name of lead principal investigator

1st name	Tomohisa
Middle name
Last name	Sujino

Organization

Keio University Hospital

Division name

Center of Diagnostic and Therapeutic Endoscopy

Zip code

160-8582

Address

35, Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-1211

Email

sujino_t@hotmail.co.jp

Name of contact person

1st name	Kai
Middle name
Last name	Tsugaru

Organization

Keio University Hospital

Division name

Department of Internal Medicine, Division of Gastroenterology and Hepatology

Zip code

160-8582

Address

35, Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-1211

Homepage URL

http://www.keio-med.jp/gastro/index.html

Email

kait721@keio.jp

Institute

Keio University Hospital
Department of Internal Medicine, Division of Gastroenterology and Hepatology

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Keio University School of Medicine, Ethics committee

Address

35, Shinanomachi, Shinjuku-ku, Tokyo, Japan

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

慶應義塾大学病院（東京都），国際医療福祉大学成田病院（千葉県），独立行政法人国立病院機構東京医療センター（東京都），川崎市立川崎病院（神奈川県），東京都済生会中央病院（東京都）, 静岡県立静岡がんセンター（静岡県）

Date of disclosure of the study information

2021

Year

06

Month

17

Day

URL releasing protocol

http://www.keio-med.jp/gastro/index.html

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2020

Year

06

Month

06

Day

Date of IRB

2020

Year

07

Month

31

Day

Anticipated trial start date

2020

Year

08

Month

01

Day

Last follow-up date

2023

Year

03

Month

31

Day

Date of closure to data entry

2023

Year

04

Month

30

Day

Date trial data considered complete

2023

Year

05

Month

31

Day

Date analysis concluded

2023

Year

06

Month

30

Day

Other related information

Anti PD-1 antibody monotherapy will be administered according to RECIST ver1.1 within the scope of public medical insurance.
About the processing of blood specimens, we request in advance to the central clinical laboratory of each institution, to extract plasma from blood drawn in a single 5ml EDTA 2Na blood collection tube for use in the study.
Before administering the first dose of anti PD-1 antibody, the patient must be fasting for at least 8 hours for blood collection (no sugar-containing beverages, but water and tea are acceptable). The collection period should be up to 1 week before the start of treatment (the same day of the previous week is acceptable).
Collect as much plasma as possible using a centrifuge at a gravitational acceleration of 1750G and a temperature setting of 4 degrees for 20 minutes. Dispense 500 microliter of the separated plasma into Eppendorf tubes. Centrifugation and dispensing should be done as soon as possible after collection. If it is difficult to do so, keep the tubes refrigerated at 4 degrees until processing, and perform the procedure within 4 hours of collection.
After processing, the above Eppendorf tubes should be stored frozen in a freezer at -60 degrees or lower at each facility.
As for the transportation of specimens, the research office will contact each facility when the planned number of patients has been registered and specimens have been collected, and the specimens will be sent to the Department of Gastroenterology, Keio University Hospital by frozen delivery.
The clinical data should be filled in one case at a time according to the CRF provided, and sent by fax as appropriate.

Registered date

2021

Year

06

Month

17

Day

Last modified on

2022

Year

10

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050902