Real-world Study on the Prevention of Neutropenia After Tumor Treatment With Mecapegfilgrastim Injection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of FN
研究概览
简要总结
This study is a multicenter, observational real-world study, aiming to observe and evaluate the efficacy and safety of prophylactic application of Mecapegfilgrastim Injection in tumor patients after radiotherapy/chemotherapy/immunotherapy in the real world to prevent neutropenia.The subjects who met the inclusion criteria of the protocol were defined as those who needed radiotherapy/chemotherapy/immunotherapy after being diagnosed with solid malignant tumors. The researchers believed that the subjects needed to use Mecapegfilgrastim Injection for primary/secondary prevention after receiving tumor treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •1. Patients with malignant tumors confirmed by histopathology or cytology;
- •Age ≥18 years old;
- •After referring to various guidelines, the researchers believed that the subjects:
- •Patients who are currently receiving treatment regimens with high FN risk;
- •Patients who are currently receiving treatment regimens for moderate FN risk and meet any one of the factors that increase the risk coefficient;
- •FN or dose-limiting neutropenia events have occurred in previous treatment cycles;
- •In addition to the above, the researchers believe that the medication regimens will cause neutropenia and affect the normal treatment of the subjects;
- •Researchers believe that they can benefit;
- •Voluntarily participate in this clinical trial and be able to sign the informed consent form in person.
排除标准
- •1. Those who are allergic to the test drug；
- •Those with mental or neurological disorders who are unable to cooperate；
- •Pregnant or lactating female patients; Women of childbearing age who refuse to take contraceptive measures；
- •Those who were considered unsuitable for inclusion by the researchers.
研究组 & 干预措施
Subjects who need radiotherapy/chemotherapy/immunotherapy after solid malignant tumors
干预措施: Mecapegfilgrastim Injection (Drug)
结局指标
主要结局
Incidence of FN
时间窗: From enrollment to the end of treatment 3 weeks later
The incidence of neutropenic fever (FN) in the first cycle
次要结局
- The incidence of grade 3 and 4 neutropenia(From enrollment to the end of treatment 6 weeks later)
研究者
Jun wang
Director of radiotherapy department 1
Hebei Medical University Fourth Hospital