Идёт набор NCT06698692

Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma

— Наблюдательное ESCC

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: В протоколе указаны: Trilaciclib Injection [Cosela].
Кому может быть актуально: Состояния в реестре: ESCC. 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

Real-world Assessment of Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma

Обзор

Clinical data of patients with synchronous radiotherapy for esophageal cancer in the Department of Radiology of Jiangsu Provincial People's Hospital were collected. Patients were divided into trilaciclib group (34 cases) and control group (169 cases) based on whether trilaciclib was used or not. Patients in the trilaciclib group were given trilaciclib before each chemotherapy treatment. Propensity score matching (PSM) was used to balance the baseline characteristics between the two groups on a 1:1 ratio. After pairing, the rates of bone marrow suppression and other adverse events were compared between the two groups.

Подробное описание

chemoradiotherapy-induced myelosuppression (CIM) is the most common adverse event of concurrent chemoradiotherapy for esophageal cancer, often leading to reduction, delay or even cessation of chemotherapeutic agents. Clinical treatments for CIM mainly include various hematopoietic growth factors and blood transfusion. However, these interventions target only a single spectrum of blood cells and are susceptible to concomitant adverse events such as bone pain, thrombosis, and fever. Trilaciclib is a potent, transient, reversible CDK4/6 inhibitor and is the world's first innovative drug with lineage-wide myeloprotective effects. Its use in esophageal cancer has not been reported yet. In this study, we investigated the clinical efficacy and safety of trilaciclib in preventing myelosuppression in concurrent chemoradiotherapy for esophageal cancer for the first time.

Вмешательства

Препарат Trilaciclib Injection [Cosela]
Trilaciclib Combined chemoradiotherapy

Первичные конечные точки

Incidence of grade ≥3 neutropenia [Срок оценки: during Trilaciclib plus chemotherapy assessed up to 1 years]

Вторичные конечные точки (1)

Incidence of Adverse Events [Срок оценки: during Trilaciclib plus chemotherapy assessed up to 1 years]

Критерии участия

Критерии включения

age ≥18 years;
pathological diagnosis of esophageal squamous cell carcinoma;
failure to undergo surgical treatment;
completion of definitive chemoradiotherapy or chemoradiotherapy combined with immunotherapy.