NCT05575986招募中4 期
An Exploring Single Arm Study on the Efficacy and Safety of Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy in Malignant Tumors of the Digestive System
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Days required for platelet recovery to ≥75×10^9/ L
研究概览
简要总结
To evaluate the efficacy and safety of hetrombopag in the treatment of thrombocytopenia after chemotherapy in patients with digestive system malignant tumors
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in clinical research and sign informed consent;
- •Age ≥18 years;
- •Digestive system malignancy confirmed by histology or cytology; Having used oxaliplatin combined with fluorouracil for at least one cycle of 21-day chemotherapy regimen (CAPOX or SOX regimen), platelet index after chemotherapy: ≥25×109/L and ≤75×109/L;
- •At least 10 days between TPO, IL-11 or platelet transfusion;
- •ECOG 0 to 2 points;
- •Expected survival time > 3 months;
- •Sufficient organ function for subsequent chemotherapy;
- •Women of reproductive age must be willing to use adequate contraception during the study of drug treatment.
排除标准
- •Thrombocytopenia caused by non-tumor chemotherapy drugs occurred within 6 months before screening, including but not limited to EDTA-dependent pseudothrombocytopenia, hypersplenism, infection, and bleeding;
- •Have any hematological malignancies, including leukemia, myeloma, bone marrow proliferative diseases, lymphoma or bone marrow proliferative diseases;
- •Clinically significant acute or active bleeding within the week prior to screening;
- •Subject has medically known hereditary prethrombotic syndrome (e.g., factor V Leiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency)
- •The subject has a history of major cardiovascular disease (e.g., congestive heart failure (New York Heart Association Class 3/ cardiac function), known arrhythmias (e.g., atrial fibrillation) that increase the risk of thromboembolic events, coronary stenting, angioplasty, or coronary artery bypass grafting);
- •Subjects had a history of arterial or venous thrombosis within 3 months before screening;
- •Use of a vitamin K antagonist (including low molecular weight heparin, factor Xa inhibitor, or thrombin inhibitor) within 7 days prior to screening;
- •The subject has a history of chronic platelet or hemorrhagic disorders, or thrombocytopenia from causes other than CIT (e.g., chronic liver disease or immune thrombocytopenic purpura);
- •TPO, IL-11 or platelet infusion were used within 10 days before enrollment;
- •Previous use of thrombopoietin receptor agonists (e.g., eltrobopag, romiestine, etc.)
- •Those who cannot be treated with oral drugs;
- •Allergic to hetrombopag or any excipient;
- •Those whose organ function could not tolerate further antitumor therapy as assessed by the investigator; This product is not recommended for use or discontinuation of treatment in patients who meet any of the following criteria for liver function
- •ALT and AST > 8 x ULN.
- •ALT or AST>5×ULN for 2 weeks;
- •ALT or AST>3xULN (total bilirubin >2xULN or INR>1.5);
- •ALT or AST>3×ULN with progressive fatigue, nausea, vomiting, right upper abdominal pain or tenderness, fever, rash, and/or eosinophilia (>5%).
研究组 & 干预措施
Observation group
Experimental
Herombopag Olamine Tablets
干预措施: Hetrombopag Olamine (Drug)
结局指标
主要结局
Days required for platelet recovery to ≥75×10^9/ L
时间窗: At the end of Cycle 1 (each cycle is 28 days)
Days required for platelet recovery to ≥75×10\^9/ L
次要结局
- The lowest platelet count(At the end of Cycle 2 (each cycle is 28 days))
- Safety of treatment(2 Cycle (each cycle is 28 days))
研究者
Xianglin Yuan
Chief physician
Huazhong University of Science and Technology
研究点 (1)
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