A Prospective, Open, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of PEG-rhG-CSF in Reducing Neutropenia in Patients With Cervical Cancer
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of III/IV neutropenia
研究概览
简要总结
A Prospective, open, randomized, controlled clinical study to evaluate the efficacy and safety of PEG-rhG-CSF(PEGylated recombinant human granulocyte stimulating factor injection) in reducing neutropenia during TP(docetaxel+cisplatin) regiment simultaneous radiochemotherapy and adjuvant chemotherapy in patients with cervical cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18, ≤70 years old;
- •Cervical cancer patients diagnosed by histopathology;
- •Need to receive multi-cycle radical concurrent radiochemotherapy;
- •FN risk > 20% if rhG-CSF was not accepted; High risk factors associated with FN and planed to use the same protocol in subsequent cycles(docetaxel+cisplatin regimen)；
- •Performance status score(KPS)≥70;
- •No obvious blood system disease,absolute neutrophil count（ANC）≥ 1.5×10^9/L, platelet count≥80×10^9 /L, hemoglobin（Hb）≥75 g/L, and no bleeding tendency;
- •The patient signs the informed consent.
排除标准
- •With infection difficult to control, or received system antibiotic treatment within 72 h before chemotherapy;
- •Any bone marrow abnormalities and other hematopoietic ;
- •Had received bone marrow or hematopoietic stem cell transplantation within 3 months;
- •with other malignancies not cure, or with brain metastases;
- •Liver function tests:total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were all ≥2.5 times normal upper limit.
- •Renal function tests: serum creatinine (Cr)> 1.5 times normal upper limit;
- •Allergic to the drugs or other genetic engineering biological products from Escherichia coli;
- •Suffering from mental or neurological disorders;
- •Investigator think it is not suitable for recruiting.
研究组 & 干预措施
PEG-rhG-CSF
PEG-rhG-CSF single-dose was administered subcutaneously 48h after chemotherapy，with patients' weight ≥ 45kg were given 6mg once per chemotherapy cycle, weight <45kg were given 3mg once per chemotherapy cycle.
干预措施: PEG-rhG-CSF (Drug)
rhG-CSF
rhG-CSF was daily administered subcutaneously 48h after chemotherapy，weight≥45kg were given 300μg/d, weight<45kg were given 150μg/d,continuous injection for 3-5 days until the absolute neutrophils count≥2×10^9/L.
干预措施: rhG-CSF (Drug)
结局指标
主要结局
Incidence of III/IV neutropenia
时间窗: 3 months
The incidence of III/IV neutropenia in each chemotherapy cycle
次要结局
- Incidence of FN(3 months)
- Proportion of chemotherapy dose adjustment(3 months)
研究者
Mei Shi
Professor
Air Force Military Medical University, China