Real-world Assessment of Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of grade ≥3 neutropenia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years;
- •pathological diagnosis of esophageal squamous cell carcinoma;
- •failure to undergo surgical treatment;
- •completion of definitive chemoradiotherapy or chemoradiotherapy combined with immunotherapy.
排除标准
- •history of other malignant tumors;
- •difficulty in follow-up;
- •insufficient clinical information.
研究组 & 干预措施
Observation group
Trilaciclib combined with chemoradiotherapy
干预措施: Trilaciclib Injection [Cosela] (Drug)
结局指标
主要结局
Incidence of grade ≥3 neutropenia
时间窗: during Trilaciclib plus chemotherapy assessed up to 1 years
Incidence of grade ≥3 neutropenia
次要结局
- Incidence of Adverse Events(during Trilaciclib plus chemotherapy assessed up to 1 years)