Real World Study of PEGylated Recombinant Human Granulocyte Stimulating Factor(PEG-rhG-CSF) in Prevention of Chemotherapy-induced Neutropenia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,500
- 主要终点
- Cost-Effectiveness
研究概览
简要总结
The aim of this study is to observe and evaluate the cost-effectiveness,efficacy and safety of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia(CIN) of cancer patients in the real world.1000 patients with non-myeloid malignancy who is planned to receive PEG-rhG-CSF for CIN prevention and 500 patients with non-myeloid malignancy who is planned to receive rhG-CSF for CIN prevention or treatment were prospectively recruited.The primary outcome was cost-effectiveness and second outcome was febrile neutropenia,the incidence and duration of grade IV neutropenia,chemotherapy delay,incidence of reduced dose of chemotherapy and relative dose intensity of chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients' age≥18 years old, male or female
- •Diagnosis of non-myeloid malignant solid tumors
- •Patients are planned to perform chemotherapy and preventive use the PEG-rhG-CSF or preventive or therapeutic use of rhG-CSF after chemotherapy
- •Patients' mental status are well, could understand the study and willing to participate the study, sign the informed consent form
- •The investigator believes that patients can benefit from this study
排除标准
- •Patients who have been confirmed to be allergic to Jinyouli® or rhG-CSF or its excipients
- •Pregnant or lactating women and women who plan to be pregnant during clinical observation
- •Other patients that the doctor believe not suitable for inclusion
研究组 & 干预措施
PEG-rhG-CSF group
This group comprised 1000 patients who received a single subcutaneous injection of PEG-rhG-CSF 24 hours after the end of chemotherapy for each chemotherapy cycle. The dose of PEG-rhG-CSF is determined by the patients' body weight, patients with body weight ≥45 kg is given to PEG-rhG-CSF 6 mg each time, patients<45 kg is given to PEG-rhG-CSF 3 mg each time.
干预措施: PEG-rhG-CSF (Drug)
结局指标
主要结局
Cost-Effectiveness
时间窗: through the chemotherapy cycles of PEG-rhG-CSF or rhG-CSF treatment,an average of 3 month
Based on the results of the incidence of febrile neutropenia(FN) and the cost perFN in each group, the incremental cost-effectiveness ratio were estimated using the following formula: (CostA-CostB)/(OutcomeA-OutcomeB)
次要结局
- The incidence of febrile neutropenia(From date of randomization until the date of the study completion,an average of 3 month)
- The incidence of grade IV neutropenia(From date of randomization until the date of the study completion,an average of 3 month)
- The duration of grade IV neutropenia in every chemotherapy cycle(From date of randomization until the date of the study completion,an average of 3 month)
- The incidence of the chemotherapy delay(From date of randomization until the date of the study completion,an average of 3 month)
- The duration of the chemotherapy delay in every chemotherapy cycle(From date of randomization until the date of the study completion,an average of 3 month)
- The incidence of the dose reduction(From date of randomization until the date of the study completion,an average of 3 month)
- Relative chemotherapy dose intensity in every chemotherapy cycle(From date of randomization until the date of the study completion,an average of 3 month)