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NCT Number: NCT06702683

The Correlation Between Blood Concentration of Sintilimab and Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongda Hospital Affiliated to Southeast University

Nanjing, Jiangsu, 210009, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. blood concentration of Sintilimab

    Time frame: From February 2023 to June 2025

Secondary outcomes

  1. the cytokines in peripheral blood

    Time frame: 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

  2. Inflammatory biomarkers in peripheral blood

    Time frame: From February 2023 to June 2025

    Inflammatory biomarkers in peripheral blood including:NLR, PLR, LMR/MLR, LIPI

  3. T lymphocyte subsets in peripheral blood

    Time frame: From February 2023 to June 2025

    T lymphocyte subsets in peripheral blood including: CD4, CD8, Th1, Th9, Th17

  4. Fatty acid and bile acid metabolism

    Time frame: 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

  5. Anti-drug antibody

    Time frame: From February 2023 to June 2025

    ADA

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Lin Liu

Other

Registry information

Official study title

Study on the Correlation Between Blood Concentration of Sintilimab and Related Predictors with Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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