NCT07829276Enrolling By Invitation不适用
A Prospective, Multicenter, Real-world Study on the Efficacy and Safety of Low-dose PEGylated Recombinant Human Granulocyte Colony-stimulating Factor (PEG rhG CSF) in Primary Prevention of Febrile Neutropenia (FN) in Cancer Patients After Chemotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- FN incidence rate
研究概览
简要总结
In a prospective, multicenter, real-world setting, the efficacy and safety of 3mg low-dose pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in the primary prevention of febrile neutropenia (FN) after chemotherapy in cancer patients were verified to address the two major clinical pain points of current fixed 6mg dose, namely economic burden and adverse reactions.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at least 18 years; 2) Confirmed diagnosis of malignant tumor through histopathology or cytological analysis; 3) Eligible for chemotherapy and capable of tolerating multiple cycles of treatment; 4) Complete medical records and a Karnofsky Performance Status (KPS) score of ≥70; 5) Normal bone marrow function (ANC ≥ 1.5×10⁹/L, platelets ≥80×10⁹/L, hemoglobin ≥75 g/L, white blood cells ≥3.0×10⁹/L); 6) Use of PEG-rhG-CSF for primary prophylaxis, administered preventively during the first cycle and subsequent cycles of chemotherapy; 7) Agreement to use effective contraception during the study period and for 6 months after discontinuation; and 8) Willingness to participate.
排除标准
- •(1) Blood routine, liver and kidney function, and electrocardiogram test results indicate contraindications for chemotherapy; (2) History of chemotherapy or radiotherapy within the past six months; (3) Prior treatment with PEG-rhG-CSF or rhG-CSF; (4) Concurrent uncontrolled infectious diseases; (5) Concurrent coagulation dysfunction; (6) Long-term alcohol or psychoactive drug dependence; (7) Tumor with bone marrow metastasis or bone marrow invasion; (8) History of hematopoietic stem cell transplantation; (9) Concurrent immune system disorders; (10) Pregnancy and lactation.
研究组 & 干预措施
Chun'an First People's Hospital
结局指标
主要结局
FN incidence rate
时间窗: From enrollment to the end of treatment at 8 weeks
次要结局
- Grade III-IV bone marrow suppression rate(From enrollment to the end of treatment at 8 weeks)
研究者
研究点 (1)
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