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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.
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| Measure | Description | Time Frame |
|---|---|---|
| blood concentration of Sintilimab | From February 2023 to June 2025 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From February 2023 to June 2025 |
| Inflammatory biomarkers in peripheral blood |
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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
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Advanced gastric cancer patients treated with sindilizumab in the Oncology Department of Zhongda Hospital Affiliated to Southeast University
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Liu | Contact | +86 13913968688 | 101012478@seu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital Affiliated to Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
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plasma
Inflammatory biomarkers in peripheral blood including:NLR, PLR, LMR/MLR, LIPI
| From February 2023 to June 2025 |
| T lymphocyte subsets in peripheral blood | T lymphocyte subsets in peripheral blood including: CD4, CD8, Th1, Th9, Th17 | 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 | From February 2023 to June 2025 |
| Anti-drug antibody | ADA | From February 2023 to June 2025 |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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