Идёт набор NCT06702683

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

— Наблюдательное Gastric Carcinoma Gastric Neoplasm Gastric (cardia, Body) Cancer Gastric Cancer Adenocarcinoma Metastatic

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Gastric Carcinoma, Gastric Neoplasm, Gastric (cardia, Body) Cancer, Gastric Cancer Adenocarcinoma Metastatic. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Study on the Correlation Between Blood Concentration of Sintilimab and Related Predictors with Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer

Обзор

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.

Первичные конечные точки

blood concentration of Sintilimab [Срок оценки: From February 2023 to June 2025]

Вторичные конечные точки (5)

the cytokines in peripheral blood [Срок оценки: From February 2023 to June 2025]
Inflammatory biomarkers in peripheral blood [Срок оценки: From February 2023 to June 2025]
T lymphocyte subsets in peripheral blood [Срок оценки: From February 2023 to June 2025]
Fatty acid and bile acid metabolism [Срок оценки: From February 2023 to June 2025]
Anti-drug antibody [Срок оценки: From February 2023 to June 2025]

Критерии участия

Критерии включения

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