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Stratification marker for immunotherapy in gastric or esphageal cancer

Exploratory study for stratification marker of immune check point inhibitor in patients with advanced or recurrent gastric or esophageal cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1031200386
Enrollment
150
Registered
2021-03-01
Start date
2021-04-28
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

gastric cancer, esophageal cancer

Interventions

None listed

Sponsors

Sasada Tetsuro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with pathologically or cytologically diagnosed, advanced or recurrent, gastric or esphageal cancer, who are treated with anti-PD-1/PL-L1 antibody (measurable target lesions for response evaluation are not required). 2) Patients over 20 years old with written informed consent 3) Patients with ECOG PS 0-2

Exclusion criteria

Exclusion criteria: 1) Patients with the past history of immunological treatments (immune checkpoint inhibitors, cancer vaccines, or immune cell therapies) 2) Patients with regular use of amino acid formulations (asintravenous or enteral nutrition) or supplements 3) Patients with presumed abnormalities of amino acid metabolism, such as liver cirrhosis, renal failure, inborn error of amino acid metabolism, pregnancy, and feeding 4) Patients enrolled in other clinical trials for pharmaceuticals or medical devices 5) Patients with active double cancer [synchronic double cancer or asynchronous double cancer with no more than 5-year disease-free period, excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured by local treatment] 6) Patients with other inappropriate conditions for enrollment judged by the clinicians

Design outcomes

Primary

MeasureTime frame
Multivariate discriminant models created by combination of plasma amino acid and/or metabolite concentrations, which are useful for predicting overall survival in patients treated with anti-PD-1/PL-L1 antibody

Secondary

MeasureTime frame
Multivariate discriminant models created by combination of plasma amino acid and/or metabolite concentrations, which are useful for predicting progression free survival in patients treated with anti-PD-1/PL-L1 antibody

Contacts

Public ContactTetsuro Sasada

Kanagawa Cancer Center

tsasada@kcch.jp+81-45-520-2222

Outcome results

None listed

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