RecruitingNCT06702683

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

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


Sponsor

Lin Liu

Enrollment

112 participants

Start Date

Feb 17, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how the blood levels of a cancer immunotherapy drug called sintilimab (a checkpoint inhibitor) relate to how well it works and what side effects it causes in patients with advanced stomach cancer or gastroesophageal junction cancer. **You may be eligible if...** - You have been diagnosed with stomach cancer or cancer at the junction of the stomach and esophagus - You are planned to receive sintilimab as part of your treatment - You are in reasonably good physical condition (ECOG 0–2) - Your expected survival is at least 3 months - You are willing to participate and follow up as required **You may NOT be eligible if...** - Your medical information or records are incomplete - You have received another immune checkpoint inhibitor drug in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Zhongda Hospital Affiliated to Southeast University

Nanjing, Jiangsu, China

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NCT06702683


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