Stratification marker for immunotherapy in gastric or esphageal cancer
- Conditions
- gastric cancer, esophageal cancer
- Registration Number
- JPRN-jRCT1031200386
- Lead Sponsor
- Sasada Tetsuro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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