Compared with other anti-tumor drugs, immune checkpoint inhibitors (ICIs) have their own unique pharmacokinetics (PK) and pharmacodynamics (PD), and affect patient clinical outcomes. However, at present, the data on the PK and PD characteristics of ICIs in the Chinese population are still lacking, thus further clinical trials are needed to verify them. At the same time, a large proportion of patients have no response to ICIs or the efficacy is poor, and even bring greater side effects, so it is particularly important to find effective biomarkers to predict the efficacy and adverse reactions of patients with ICIs treatment.The purpose of this study is to explore the correlation between blood concentration of Sintilimab and related predictors with efficacy and adverse reactions in patients with advanced gastric cancer so as to provide clinical reference for individualized treatment of patients with gastric cancer.
Study Type
OBSERVATIONAL
Enrollment
112
Zhongda Hospital Affiliated to Southeast University
Nanjing, Jiangsu, China
RECRUITINGblood concentration of Sintilimab
Time frame: From February 2023 to June 2025
the cytokines in peripheral blood
the cytokines in peripheral blood including:IL -1β, IL-2, IL-4, IL-6, IL-8, IL-10, IFN-γ, TNF-α, TNF-β
Time frame: From February 2023 to June 2025
Inflammatory biomarkers in peripheral blood
Inflammatory biomarkers in peripheral blood including:NLR, PLR, LMR/MLR, LIPI
Time frame: From February 2023 to June 2025
T lymphocyte subsets in peripheral blood
T lymphocyte subsets in peripheral blood including: CD4, CD8, Th1, Th9, Th17
Time frame: From February 2023 to June 2025
Fatty acid and bile acid metabolism
Fatty acid and bile acid metabolism:short-chain fatty acid including:ursodeoxycholic acid, short-chain fatty acid, polyunsaturated fatty acids
Time frame: From February 2023 to June 2025
Anti-drug antibody
ADA
Time frame: From February 2023 to June 2025
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