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

Recruiting

• Conditions: Gastric Carcinoma; Gastric Neoplasm; Gastric (cardia, Body) Cancer; Gastric Cancer Adenocarcinoma Metastatic

• Registration Number: NCT06702683
• Lead Sponsor: Lin Liu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-17
• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
blood concentration of Sintilimab	From February 2023 to June 2025

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zhongda Hospital Affiliated to Southeast University; 🇨🇳 Nanjing, Jiangsu, China