To Evaluate the Protective Effect of Trilaciclib on Myelosuppression in Patients With Limited-stage Small Cell Lung Cancer Associated With Concurrent Chemoradiotherapy and Discuss the Effect of Gut Microbiota Changes on Myelosuppression
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Occurrence of severe neutropenia
研究概览
简要总结
To evaluate the protective effect of Trilaciclib on myelosuppression in patients with limited-stage small cell lung cancer associated with concurrent chemoradiotherapy and discuss the effect of gut microbiota changes on myelosuppression
详细描述
The occurrence of myelosuppression following chemotherapy, including severe neutropenia and hematological toxicity (Grade 3/4), as well as its association with dynamic changes in the gut microbiota, was investigated in conjunction with prophylactic administration of the CDK4/6 inhibitor Trilaciclib prior to the initiation of chemotherapy during radiotherapy for limited stage small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The histopathology is limited-stage small cell lung cancer.
- •ECOG score 0-
- •Good organ function (no blood transfusions, no hematopoietic stimulating factors, no transfusions of albumin or blood products within 14 days prior to the examination).
- •It is suitable for patients treated with Trilaciclib combined with etoposide plus cisplatin or carboplatin.
- •Understand and can sign informed consent
排除标准
- •Brain metastases with clinical symptoms require local radiotherapy or hormone therapy.
- •Active infections require systemic treatment.
- •Subjects with active, known or suspected autoimmune disease or history of autoimmune disease.
- •Combined with other tumors.
- •The current or previous presence of a clinically significant and medically unstable condition, which in the investigator's professional judgment may compromise subject safety, interfere with study evaluation or endpoint assessment, or otherwise impact the reliability of study results.
研究组 & 干预措施
Trilaciclib combined with concurrent chemoradiotherapy
Trilaciclib is used simultaneously before the first cycle of chemotherapy during radiotherapy for limited-stage small cell lung cancer
干预措施: Trilaciclib (Drug)
结局指标
主要结局
Occurrence of severe neutropenia
时间窗: 14 days
Grade 3/4 decline in neutropenia after the first cycle of chemotherapy during radiotherapy
Duration of severe neutropenia
时间窗: 5 days
Duration of severe neutropenia after the first cycle of chemotherapy during radiotherapy (ANC\<1.0×10\^9/L for more than 5 days)
Occurrence of hematological toxicity
时间窗: 5 days
Grade 3/4 decline in neutrophils, platelets, and red blood cells
次要结局
未报告次要终点