跳至主要内容
临床试验/NCT02344979
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

Shenyang Sunshine Pharmaceutical Co., LTD.1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年5月最近更新:
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:

  1. Patients aged 18 years -75 years, male or female;
  2. histologically or cytologically confirmed non-small cell lung cancer;
  3. consistent with the indication of chemotherapy
  4. the decrease of platelets appeared in the screen chemotherapy period and the platelet count is less than 50 * 109/ L;
  5. the expected survival was more than 3 months;
  6. patients must have the ability to understand and the willingness to sign a written informed consent;
  7. to be able to follow the study and follow-up procedures

Exclusion Criteria:

  1. pregnant or lactating women;
  2. patients who had severe allergic history on biological preparation;
  3. the existing serious acute infection without control;
  4. Patients receiving radiotherapy;
  5. 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;
  6. with a history of pulmonary embolism, myocardial infarction patients, thrombus history of thrombosis or activity in the past 3 months;
  7. Sepsis, disseminated intravascular coagulation (DIC); hypersplenism or any other illness sickness that can exacerbate thrombocytopenia appeared in the previous cycles of chemotherapy;
  8. 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

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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