UMIN-ICDS Clinical Trial

Unique ID issued by UMIN	UMIN000034836
Receipt number	R000039728
Scientific Title	A multi-center retrospective observational study to evaluate PD-L1 protein expression, EBV positivity and the frequency of MSI-H in patients with advanced gastric and esophagogastric junction adenocarcinoma in Japan
Date of disclosure of the study information	2018/11/12
Last modified on	2022/03/07 21:57:11

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Basic information

Public title

A multi-center retrospective observational study to evaluate PD-L1 protein expression, EBV positivity and the frequency of MSI-H in patients with advanced gastric and esophagogastric junction adenocarcinoma in Japan

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

advanced gastric and esophagogastric junction adenocarcinoma

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

In clinical studies of pembrolizumab in advanced gastric and esophagogastric junction adenocarcinoma, PD-L1 expression has been evaluated by the Combined Positive Score (CPS) scoring method using the 22C3 antibody. There is no relevant data that examined the PD-L1 protein expression in Japanese population with the same method

Basic objectives2

Others

Basic objectives -Others

Molecular epidemiology study

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Assessment

Primary outcomes

PD-L1 expression (evaluation by the CPS) measured by PD-L1 IHC 22C3 pharmDx kit; EBV positivity; and Microsatellite instability frequency.

Key secondary outcomes

To characterize association between PD-L1 expression and other molecular biological factors (HER2 expression and H. pylori infection) in Japanese patients with advanced gastric and esophagogastric junction adenocarcinoma.

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) Japanese patients with advanced gastric and esophagogastric junction adenocarcinoma who were diagnosed with pStage II or III after surgical resection in or after 2014 and experienced recurrence at or after 6 months after postoperative adjuvant chemotherapy; or who were diagnosed with unresectable advanced cancer (Stage IV) and underwent tumor sampling in or after 2014
2) Patients with archived tumor samples from which 14 paraffin sections can be obtained
3) Patients aged at least 20 years at the time of sampling
4) Patients who give written consents for participation in this study by themselves, in principle, or by legally acceptable representatives

Key exclusion criteria

1) Patients with other primary tumor types at the time the tissue sample was collected
2) Patients who had underwent radiation therapy before tumor sampling
3) Patients who had received systemic chemotherapy before tumor sampling
4) Patients with tumor samples that were obtained before 2014
5) Patients with tumor tissues that were thinly sliced more than 6 months ago
6) Patients with less than 100 tumor cells available
7) Patients whose samples are considered to be in an extremely poor preservation condition by the investigators
8) Other patients whose enrollment in the study is considered inappropriate by the investigators

Target sample size

400

Research contact person

Name of lead principal investigator

1st name Akiko

Middle name

Last name Shimizu

Organization

MSD K.K.

Division name

oncology medical affairs

Zip code

102-8667

Address

1-13-12 Kudan-kita, Chiyoda-ku, Tokyo

TEL

03-6372-0665

Email

ldgproject@merck.com

Public contact

Name of contact person

1st name Iida

Middle name

Last name Fumiyuki

Organization

EP Cruise Co.,Ltd.

Division name

Project promotion department

Zip code

160-0023

Address

KDX Shinjuku Bldg. 9F 3-2-7 Nishi-Shinjuku, Shinjuku-ku, Tokyo

TEL

03-6901-6079

Homepage URL

Email

PD-L1@sogo-medefi.jp

Sponsor or person

Institute

Profit organization

Institute

Department

Personal name

Funding Source

Organization

Profit organization

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

Ethic Committee

Address

840 Shijo-cho, Kashihara, Nara JAPAN

Tel

0744-22-3051

Email

ino_rinri@naramed-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 12 Day

Related information

URL releasing protocol

https://www.tandfonline.com/doi/full/10.1080/15384047.2022.2038002

Publication of results

Published

Result

URL related to results and publications

https://www.tandfonline.com/doi/full/10.1080/15384047.2022.2038002

Number of participants that the trial has enrolled

391

Results

241/389 (62%) were PD-L1 positive, 24/379 (6.3%) had MSI-H tumors, and 13/389 (3.3%) were EBV positive. Among patients with MSI-H tumors and EBV-positive tumors, 19/24 (79.2%) and 9/13 (69.2%), respectively, were PD-L1 positive. A greater proportion of patients with MSI-H tumors (83.3% [20/24]) were PD-L1 positive than those with MSI-low/stable tumors (60.8% [216/355]; p = .0297)

Results date posted

2022 Year 03 Month 07 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The study enrolled Japanese patients aged over 20 years (at sampling) with Stage II or III advanced gastric and GEJ adenocarcinoma following surgical resection in or after 2014 and who experienced recurrence at or after 6 months following postoperative adjuvant chemotherapy or who were diagnosed with unresectable advanced cancer (Stage IV) and underwent tumor sampling in or after 2014. Patients were required to have archived tissue specimens adequate to provide 14 paraffin sections.

Participant flow

Adverse events

Outcome measures

The primary objectives were prevalence of PD-L1 expression (combined positive score [CPS]over 1), MSI status, and EBV positivity.

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 03 Month 27 Day

Date of IRB

2018 Year 11 Month 19 Day

Anticipated trial start date

2018 Year 11 Month 21 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

multicenter reterospective observational study

Management information

Registered date

2018 Year 11 Month 09 Day

Last modified on

2022 Year 03 Month 07 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039728

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name