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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 112

Contacts and Locations

• Study Contact: Name: Lin Liu; Phone Number: +86 13913968688; Email: 101012478@seu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital Affiliated to Southeast University
      • Contact: Lin Liu; Phone Number: +86 13913968688; Email: 101012478@seu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
blood concentration of Sintilimab	From February 2023 to June 2025

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Lin Liu

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Estimated): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2022ZDSYLL329-P01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No