Gastric Cancer Adenocarcinoma Metastatic, Gastric Carcinoma, Gastric (cardia, Body) Cancer, Gastric Neoplasm
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Lin Liu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A. Patients who were diagnosed with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; B. Patients who plan to be treated with Sintilimab; C.ECOG score of 0-2; D. Expected survival ≥3 months; E. The patient who have good compliance, follow-up, and can cooperate with relevant treatment and examination; F. Agree to participate in the study and sign the informed consent
Exclusion criteria
A. Patients who clinical information and data are incomplete; B. Patients who treated with immune checkpoint inhibitors within 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood concentration of Sintilimab | From February 2023 to June 2025 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the cytokines in peripheral blood | From February 2023 to June 2025 | the cytokines in peripheral blood including:IL -1β, IL-2, IL-4, IL-6, IL-8, IL-10, IFN-γ, TNF-α, TNF-β |
| Inflammatory biomarkers in peripheral blood | From February 2023 to June 2025 | Inflammatory biomarkers in peripheral blood including:NLR, PLR, LMR/MLR, LIPI |
| T lymphocyte subsets in peripheral blood | From February 2023 to June 2025 | T lymphocyte subsets in peripheral blood including: CD4, CD8, Th1, Th9, Th17 |
| Fatty acid and bile acid metabolism | From February 2023 to June 2025 | Fatty acid and bile acid metabolism:short-chain fatty acid including:ursodeoxycholic acid, short-chain fatty acid, polyunsaturated fatty acids |
| Anti-drug antibody | From February 2023 to June 2025 | ADA |
Countries
China
Contacts
Primary ContactLin Liu
Outcome results
None listed