NCT04171986Unknown不适用
Mecapegfilgrastim Prevents Prospective, One-arm, Single-center Study of Concurrent Hyperfractionated Chemoradiotherapy With Neutropenia and Radiation Esophagitis in Limited-stage Small Cell Lung Cance
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2019年11月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- The incidence of neutrophil radiation esophagitis begins with hyperfractionated chemoradiotherapy.
研究概览
简要总结
Evaluation of the efficacy and safety of Mecapegfilgrastim for the prevention of neutropenia and radiation esophagitis after hyperfractionation in patients with limited-stage small cell lung cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Patients with limited small cell lung cancer diagnosed by histopathology;
- •ECOG 0-1 points;
- •Weight ≥ 45 kg;
- •Age 18-75 years old;
- •It is expected that at least 2 cycles of EP chemotherapy will be completed as planned; once thiophene penicillin is used, chemotherapy should not be re-dosed within 12 days.
- •Bone marrow hematopoietic function is normal, no bleeding tendency (INR<1.5);
- •Laboratory tests are subject to: (1) Blood routine examination: Hb≥90g/L; WBC≥4.0×109/ L; ANC≥2.0×109/L; PLT≥100×109/L. (2) Liver function, biochemical examination: ALT and AST≤1.5×ULN; TBIL≤1.5×ULN; Serum creatinine≤1.5×ULN.
- •According to the researcher's judgment, the test plan can be observed;
- •Volunteer to participate in this clinical trial, understand the research process and be able to sign informed consent in writing.
排除标准
- •There are currently uncontrolled infections or systemic antibiotics within 72 hours of receiving chemotherapy;
- •Any abnormal bone marrow hyperplasia and other hematopoietic dysfunction;
- •Patients who have received bone marrow or hematopoietic stem cell transplantation within the past 3 months;
- •Patients with previous malignant tumors that have not been cured or have brain metastases;
- •Liver function tests Total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are >2.5 times the upper limit of normal; if due to liver metastasis, the above indicators are >5 times the upper limit of normal;
- •Renal function test: serum creatinine (Cr) > 1.5 times the upper limit of normal;
- •Those who are allergic to this product;
- •suffering from mental or neurological disorders that cannot be matched;
- •Female patients during pregnancy or lactation; women of childbearing age who refuse to receive contraception;
- •The investigator believes that it is not suitable for inclusion.
研究组 & 干预措施
Test Group
Experimental
干预措施: Mecapegfilgrastim (Drug)
结局指标
主要结局
The incidence of neutrophil radiation esophagitis begins with hyperfractionated chemoradiotherapy.
时间窗: 6 weeks
Incidence of 3 and 4 degrees neutropenia within 6 weeks from the start of hyperfractionated radiotherapy
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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