NCT02344979Unknown不适用
The Study of rHuTPO/rHuIL-11 in the Treatment for Chemotherapy-induced Thrombocytopenia in Patients With NSCLC Receiving Gemcitabine and Cisplatin or Carboplatin Chemotherapy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The mean minimal and maximal platelet count after rHuTPO or rHuIL-11.
研究概览
简要总结
Purpose: To evaluate the efficacy and safety of rHuTPO/rHuIL-11 in the treatment for chemotherapy-induced thrombocytopenia in patients with NSCLC receiving gemcitabine and cisplatin or carboplatin chemotherapy.
详细描述
Inclusion Criteria:
- Patients aged 18 years -75 years, male or female;
- histologically or cytologically confirmed non-small cell lung cancer;
- consistent with the indication of chemotherapy
- the decrease of platelets appeared in the screen chemotherapy period and the platelet count is less than 50 * 109/ L;
- the expected survival was more than 3 months;
- patients must have the ability to understand and the willingness to sign a written informed consent;
- to be able to follow the study and follow-up procedures
Exclusion Criteria:
- pregnant or lactating women;
- patients who had severe allergic history on biological preparation;
- the existing serious acute infection without control;
- Patients receiving radiotherapy;
- more than 3 metastatic tumor of bone were found in the screening period, and the platelet count did not restore to 100 * 109/ L on the screening period on the seventeenth day of the screening period;
- with a history of pulmonary embolism, myocardial infarction patients, thrombus history of thrombosis or activity in the past 3 months;
- Sepsis, disseminated intravascular coagulation (DIC); hypersplenism or any other illness sickness that can exacerbate thrombocytopenia appeared in the previous cycles of chemotherapy;
- tumor metastasis was found in the central nervous system;
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years, Male or females
- •Patients with NSCLC for whom treatment with gemcitabine and cisplatin or carboplatin
- •Platele counts ≤ 50×109/L during Screening chemo cycle
- •ECOG PS score is ≤ 2
- •The predicted life expectancy ≥3 months
- •Written informed consent
排除标准
- •Pregnant or nursing women
- •Known history of severe anaphylactic reaction to biologics
- •Uncontrolled severe infection
- •History of bone or central nervous system metastasis
- •History of platelet disorder
- •Active bleeding
结局指标
主要结局
The mean minimal and maximal platelet count after rHuTPO or rHuIL-11.
时间窗: 28days
次要结局
- The time to achieve platelet count ≥75×109/L and ≥100×109/L after rHuTPO or rHuIL-11. The duration of platelet count <50×109/L after rHuTPO or rHuIL-11.(28days)
- The number of platelet transfusions after rHuTPO or rHuIL-11.(28days)
研究者
研究点 (1)
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