Clinical Trial on the Prevention of Thrombocytopenia After First-line Chemotherapy With GC/GP Regimens for Non-small-cell Lung Carcinoma Using Recombinant Human Thrombopoietin (rhTPO)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- minimum and maximum value of platelet count after chemotherapy
研究概览
简要总结
To assess the efficacy and safety of administration of rhTPO at different time in the treatment of thrombocytopenia caused by first-line GC/GP regimen for non small cell lung cancer (NSCLC)
详细描述
This is a randomized, controlled, open-labeled, multicenter clinical trial. The subjects are patients with NSCLC who are going to receive GC/GP regimen chemotherapy.
Vadhan-Raj et al conducted a study in which they administered rhTPO in various ways to patients with sarcoma receiving platinum-containing chemotherapy. The results demonstrated that timing of administration of rhTPO can be adjusted according to the occurrence time of nadir platelet values induced by chemotherapy. The timing of administration of rhTPO in this study was determined based on the above proofs.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients at the age of 18 to 75 years old
- •Histologically or cytologically diagnosed NSCLC cases
- •Thrombocytopenia occurred in the selected chemotherapy cycle confirmed by double test results with platelet count lower than 75×109/L
- •Fit for chemotherapy (WBC ≥ 4.0×109/L；neutrophil count> 1.5×109/L；PLT ≥ 80×109/L；ALT ≤ 3 times the upper limit of normal range；AST ≤ 3 times the upper limit of normal range；TBil ≤ twice the upper limit of normal range；ECOG PS ≤ 2；without severe cardiopulmonary defects)
- •Expected lifespan over 12 weeks
- •With understanding ability and voluntarily sign informed consent form
- •Be able to comply with the study and follow-up process
排除标准
- •With any unstable systemic diseases including active infection, uncontrolled hypertension, liver diseases, renal diseases or metabolic diseases
- •With uncontrolled brain metastasis symptoms (patients whose brain metastasis controlled over 4 weeks without hormone therapy can still be enrolled)
- •With heart cerebrovascular diseases, congestive heart failure with NYHA above II degree, with unstable angina pectoris, with acute myocardial infarction or cerebral infarction within 6 months
- •Breast-feeding or pregnant women
- •Platelet count over 300×109/L
研究组 & 干预措施
Treatment group
rhTPO(recombinant human thrombopoietin) is given on the second, 4th and 9th day of the chemotherapy cycle in a dosage of 15000U once subcutaneously.
干预措施: recombinant human thrombopoietin (Drug)
Control group
15000U of rhTPO(recombinant human thrombopoietin) is given subcutaneously 6 to 24 hours within the end of chemotherapy cycle, that is, the 8th day for 3 consecutive days (d9 to d11)
干预措施: recombinant human thrombopoietin (Drug)
结局指标
主要结局
minimum and maximum value of platelet count after chemotherapy
时间窗: nine weeks
To evaluate the minimum and maximum value of platelet count after chemotherapy and the value of platelet count and their D-values comparing with the baseline values
次要结局
- The duration when patient's platelet count remains below 50×109/L(nine weeks)
研究者
Yi-Long Wu
Vice President of Guangdong General Hospital, Guangdong Academy of Medical Sciences
Chinese Society of Lung Cancer