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

NCT06702683 | Recruiting

• 1 other identifier: 2022ZDSYLL329-P01
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• blood concentration of Sintilimab

  From February 2023 to June 2025

Secondary Outcomes (5)

• the cytokines in peripheral blood

  From February 2023 to June 2025

• Inflammatory biomarkers in peripheral blood

  From February 2023 to June 2025

• T lymphocyte subsets in peripheral blood

  From February 2023 to June 2025

• Fatty acid and bile acid metabolism

  From February 2023 to June 2025

• Anti-drug antibody

  From February 2023 to June 2025

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• A. Patients who clinical information and data are incomplete; B. Patients who treated with immune checkpoint inhibitors within 6 months

Sponsors & Collaborators

• Lin Liu: lead

Study Sites (1)

Zhongda Hospital Affiliated to Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Lin Liu

CONTACT

+86 13913968688; 101012478@seu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician of Oncology Department

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 25, 2024
• Study Start: February 17, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)