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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLin Liu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Advanced gastric cancer patients treated with sindilizumab in the Oncology Department of Zhongda Hospital Affiliated to Southeast University

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

blood concentration of Sintilimab

Time frame
From February 2023 to June 2025

Secondary outcomes

1

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
2

Inflammatory biomarkers in peripheral blood

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

Time frame
From February 2023 to June 2025
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lin Liu

Lead sponsor

Zhongda Hospital

Sponsor institution