NCT05252091Unknown2 期
An Exploratory Clinical Study of Herombopag Olamine Tablets for Thrombocytopenia Induced by Chemotherapy Combined With Immunotherapy in Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 主要终点
- Evaluate the response rate of hetrombopag
研究概览
简要总结
The purpose of this study is to explore the safety and efficacy of herombopag olamine tablets for thrombocytopenia induced by chemotherapy combined with immunotherapy in non-small cell lung cancer
详细描述
To observe and evaluate the safety and efficacy of the TPO receptor agonist herombopag for the secondary prevention of thrombocytopenia caused by chemotherapy combined with immunotherapy in non-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
- 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
- •The patients signed the informed consent and voluntarily joined the study;
- •Age 18-75 years old, male or female;
- •Patients with stage IIIb-IV non-small cell lung cancer diagnosed by histopathology or cytology, who have received and will continue to receive carboplatin-based chemotherapy combined with pemetrexed or nab-paclitaxel, combined with immune checkpoint inhibitors ( ICIs) treatment;
- •The investigator determined that the patient could receive hetrombopag administration;
- •Thrombocytopenia of grade 2 or above occurred in the last chemotherapy cycle, defined as platelet count (PLT) ≤ 75×109/L;
- •The values of laboratory tests performed for screening shall meet the following criteria:
- •Blood routine examination: a) Hemoglobin (HB) ≥ 90 g/L; b) Absolute neutrophil count (ANC) ≥ 1.5×109/L; c) Platelet count (PLT) ≥ 80×109/L; 2) Biochemical tests: a) AST and ALT ≤ 3 times ULN (if there is tumor liver metastasis, ≤ 5 times ULN); b) TBiL ≤ 2 times ULN; c) Cr ≤ 2 times ULN, or creatinine clearance (CrCL) ≥60 mL/min (Cockcroft-Gault formula);
- •Life expectancy at screening ≥12 weeks;
- •The main organ functions are normal, and there are no serious complications;
排除标准
- •pregnant or breastfeeding women;
- •Inability to understand the research nature of the research or to obtain informed consent;
- •The investigator judges other circumstances that are not suitable for inclusion in the study;
- •Thrombocytopenia caused by other causes other than those caused by chemotherapy or immunotherapy (such as chronic liver disease, sepsis, disseminated intravascular coagulation, immune thrombocytopenia, etc.);
- •Have unstable angina pectoris, congestive heart failure, uncontrolled hypertension, uncontrolled arrhythmia or recent (within 1 year of screening) history of myocardial infarction;
- •Those with a history of blood disease or tumor bone marrow infiltration;
- •Those who received concurrent radiotherapy and those who received pelvic radiotherapy in the past;
- •Arterial or venous thrombotic events within the past 6 months;
- •There are currently uncontrollable infections.
研究组 & 干预措施
herombopag olamine tablets
Experimental
干预措施: herombopag olamine tablets (Drug)
结局指标
主要结局
Evaluate the response rate of hetrombopag
时间窗: Follow-up to 28 days after the last use of herombopag
response if all of the following criteria are met: 1. No need for platelet transfusion 2. No need to reduce chemotherapy drug dose due to thrombocytopenia 3. No need to delay chemotherapy due to thrombocytopenia) Note: chemotherapy drug dose reduction It was defined as reducing the dose of the original chemotherapy drug by ≥20%, and chemotherapy delay was defined as delaying chemotherapy by \>7 days.
次要结局
- The duration of platelets ≤50×109/L;(Follow-up to 28 days after the last use of herombopag)
- The lowest platelet value after chemotherapy(Follow-up to 28 days after the last use of herombopag)
- Platelet recovery to the highest value after chemotherapy;(Follow-up to 28 days after the last use of herombopag)
- The time for platelets to recover to more than 100×109/L;(Follow-up to 28 days after the last use of herombopag)
- Incidence of adverse events(Follow-up to 28 days after the last use of herombopag)
研究者
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