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

Lin Liu

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06702683

2022ZDSYLL329-P01

Details and patient eligibility

About

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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