O LIMIT Study

Phase 2

Completed

• Conditions: Advanced gastric or esophago-gastric junction MSI-H tumor.

• Registration Number: JPRN-jRCT2080225304
• Lead Sponsor: Hisato Kawakami (Coordinating Investigator)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1.Subjects must have histologically confirmed adenocarcinoma of gastric or esophago-gastric junction.
2.Subject must have unresectable advanced, recurrent or metastatic gastric or esophago-gastric junction adenocarcinoma.
3.Subjects must have confirmed MSI-H.
4.Subjects must not be amenable to curative approaches such as definitive chemoradiation and/or surgery.
5.No prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease.
6.ECOG performance status of 0 or 1..

Exclusion Criteria

1.Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before enrollment.
2.Subjects who received radiation therapy for local control or pain control within 14 days prior to enrollment.
3.Subjects who received blood transfusion or hematopoietics within 14 days prior to enrollment.
4.Other prior malignancy requiring active treatment within the previous 3 years from enrollment .

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>ORR (Central assessment)

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>other<br>ORR (Investigator assessment)<br>Disease Control Rate(CR+PR+SD)(Central and Investigator assessments) <br>PFS((Central and Investigator assessments)<br>OS<br>DoR(Central and Investigator assessments)<br>Time to response(Central and Investigator assessments)<br>safety and tolerability<br>concordance rate of MSI-H between assays.<br>To explore potential biomarkers associated with clinical efficacy (ORR, PFS, OS) and/or with incidence of adverse events