Clinical trial NCT06702683: The Correlation Between Blood Concentration of Sintilimab and Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer
Official title: Study on the Correlation Between Blood Concentration of Sintilimab and Related Predictors with Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Carcinoma
Gastric Neoplasm
Gastric (cardia, Body) Cancer
Gastric Cancer Adenocarcinoma Metastatic
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: blood concentration of Sintilimab
timeFrame: From February 2023 to June 2025
Secondary outcomes:
measure: the cytokines in peripheral blood
timeFrame: From February 2023 to June 2025
measure: Inflammatory biomarkers in peripheral blood
timeFrame: From February 2023 to June 2025
measure: T lymphocyte subsets in peripheral blood
timeFrame: From February 2023 to June 2025
measure: Fatty acid and bile acid metabolism
timeFrame: From February 2023 to June 2025
measure: Anti-drug antibody
timeFrame: From February 2023 to June 2025
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital Affiliated to Southeast University
state: Jiangsu
Study officials:
References: