NCT07649395已完成不适用
A Prospective Study of the Early Treatment of Recombinant Human Thrombopoietin for Chemoradiation Induced Thrombocytopenia in Cervical Squamous Cell Carcinoma Patient
Mei Feng1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2021年2月1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
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- the incidence of severe CTIT (Cancer Treatment-Induced Thrombocytopenia , Grade 3 - Grade 5)
研究概览
简要总结
To explore the early intervention timing of recombinant human thrombopoietin (rhTPO) for cancer treatment-induced thrombocytopenia (CTIT) in cervical squamous cell carcinoma (CSCC) patients during concurrent chemoradiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •KPS(Karnofsky Performance Status) >60 points;
- •histopathologically or cytologically confirmed stage I-IVa CSCC (FIGO 2018); 3.18-70 years; receiving radical CCRT;
- •4.receiving rhTPO treatment when they occurred G1 or G2 CTIT at first presentation during CCRT; 5.expected survival time ≥6 months
排除标准
- •patients with haematopoietic system diseases, including lymphoma, leukaemia, aplastic anaemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndromes;
- •patients who had experienced non-CTIT within 6 months before screening, including but not limited to EDTA(Ethylenediaminetetraacetic acid)-dependent pseudothrombocytopenia, hypersplenism, infection, bleeding, etc.;
- •patients who had severe visceral bleeding or intracranial haemorrhage before enrolment; any arterial or venous thrombosis within 6 months before screening;
- •patients with severe cardiovascular diseases or arrhythmias that increase the risk of thrombus formation, coronary stent placement, angioplasty, and coronary artery bypass grafts within the prior 6 months;
- •patients who had received platelet-producing drugs such as recombinant human interleukin 11(rhIL-11) within 1 week before the administration of the study drug;
- •haemoglobin <50g/L after red blood cell transfusion or erythropoietin treatment or absolute neutrophil count <1.0×109/L after granulocyte colony-stimulating factor treatment;
- •patients participating in clinical trials or who participated in an investigational drug trial within 4 weeks and received study treatment or investigational devices;
- •and patients who were considered by the investigator to be inappropriate for inclusion for other reasons.
研究组 & 干预措施
Experimental group 1
Experimental
receiving rhTPO treatment when they occurred G1(100×109/L>PLT(Platelet)>75×109/L) CTIT at first presentation during CCRT(Concurrent Chemoradiotherapy)
干预措施: rhTPO (Drug)
Experimental group 2
Experimental
receiving rhTPO treatment when they occurred G2(75×109/L>PLT(Platelet)>50×109/L) CTIT at first presentation during CCRT(Concurrent Chemoradiotherapy)
干预措施: rhTPO (Drug)
结局指标
主要结局
the incidence of severe CTIT (Cancer Treatment-Induced Thrombocytopenia , Grade 3 - Grade 5)
时间窗: 6 months
次要结局
未报告次要终点
研究者
Mei Feng
Director
Sichuan Cancer Hospital and Research Institute
研究点 (1)
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