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

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 - 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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000034836

Enrollment

400

Registered

2018-11-12

Start date

2018-11-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced gastric and esophagogastric junction adenocarcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactIida Fumiyuki

EP Cruise Co.,Ltd. Project promotion department

PD-L1@sogo-medefi.jp03-6901-6079

Outcome results