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A prospective observational study of screening for MSI status in unresectable chemo-naive advanced gastric cancer:WJOG13320GPS

A prospective observational study of screening for MSI status in unresectable advanced gastric cancer: WJOG13320GPS - An observational study evaluating MSI status in unresectable advanced gastric cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000040366
Enrollment
1000
Registered
2020-05-11
Start date
2020-10-05
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

unresectable advanced gastric cancer

Interventions

None listed

Sponsors

West Japan Oncology Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically confirmed gastric or esophago-gastric junction adenocarcinoma 2)Unresectable locally advanced or metastatic adenocarcinoma of the stomach or esophago-gastric junction 3)Eastern Cooperative Oncology Group (ECOG)Performance status of 0 or 1 4)Having evaluable disease 5)No prior systemic anticancer therapy for advanced or metastatic disease. For recurrent gastric cancer patients, the last administration of prior adjuvant or neoadjuvant chemotherapy was done at least 24 weeks before enrollment. 6)Adequate organ function 7)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Having concomitant active malignancies. 2)Requiring systemic corticosteroid or immunosuppressant. 3)History of prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other antibody which specifically targets T-cell co-stimulation or checkpoint pathways. 4)Inappropriate judged by the investigators.

Design outcomes

Primary

MeasureTime frame
The proportion of patients with MSI-high in chemotherapy-naive gastric cancer

Secondary

MeasureTime frame
1) Clinicopathological features of advanced or recurrent gastric cancer with MSI-high status 2) Turn-around-time of MSI test 3) Success rate of MSI test

Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026