Clinical Study on the Efficacy and Safety of Hetropapa Ethanolamine Tablets in the Treatment of Thrombocytopenia Caused by Concurrent Radiotherapy and Chemotherapy in Cervical Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Platelet index
研究概览
简要总结
This study is a single arm, single center and exploratory clinical study, which aims to explore the efficacy and safety of hetropapa ethanolamine tablets in the treatment of thrombocytopenia caused by concurrent radiotherapy and chemotherapy of cervical cancer. The primary end point was the proportion of subjects who were effective after treatment with hetropapa in the first cycle after treatment, that is, the platelet value recovered to ≥ 100 x 109 / L after treatment. The main inclusion criteria were: voluntary participation in the trial and signing informed consent; Age ≥ 18 years old, regardless of gender; Cervical cancer was diagnosed by histopathology or cytology; Platelet < 75 × 109/L； At the time of screening, the expected survival time is ≥ 12 weeks, and can be treated with the current chemotherapy regimen for at least 1 cycle.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in the trial and sign the informed consent form; Age ≥ 18 years old, regardless of gender; Cervical cancer was diagnosed by histopathology or cytology; Platelet < 75 × 109/L At the time of screening, the expected survival time is ≥ 12 weeks, and can be treated with the current chemotherapy regimen for at least 1 cycle
排除标准
- •Screening or baseline platelet value < 30 × 109/L Suffering from the following hematopoietic system diseases other than thrombocytopenia (CIT) caused by tumor chemotherapy drugs, including but not limited to leukemia, primary immune thrombocytopenia, bone marrow proliferative diseases, multiple myeloma and myelodysplastic syndrome; Thrombocytopenia caused by causes other than CIT occurred within 6 months before screening, including but not limited to chronic liver disease, hypersplenism, infection and bleeding; Clinical manifestations of severe bleeding within 2 weeks before screening, such as gastrointestinal tract or central nervous system bleeding; Neutrophil absolute value < 1.0 × 109 / L, hemoglobin < 80g / L; It is allowed to use granulocyte colony stimulating factor, erythrocyte and EPO infusion in line with clinical routine; The researcher believes that participating in the trial has a great risk to the subject's health or safety, or other situations that may affect the efficacy evaluation.
研究组 & 干预措施
test group
干预措施: Herombopag Olamine (Drug)
结局指标
主要结局
Platelet index
时间窗: Blood routine tests were conducted every three days within 14 days after taking the drug
Destroy after use
次要结局
未报告次要终点
研究者
Wu jin rong
researcher
Second Hospital of Shanxi Medical University