A Prospective, Multi-cohort, Open-label Clinical Study of the Efficacy and Safety of Herombopag in Tumors-associated Thrombocytopenia
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 主要终点
- During the correction period, the percentage of patients whose platelets returned to normal within 14 days
研究概览
简要总结
The purpose of this study is to confirm the safety and efficacy of Herombopag in tumors-associated thrombocytopenia
详细描述
CIT is one of the most common complications of tumor treatment, which is caused by the inhibition of anticancer chemotherapy drugs on megakaryocytes in bone marrow, resulting in platelet count lower than 100×109/L in peripheral blood, and is a common hematological toxic reaction in clinic. CIT leads to an increased risk of bleeding and transfusion, and severe CIT can cause intracranial bleeding and death. The use of platelet infusion is limited and ineffective in 25% of patients. rhIL-11 increases the incidence of cardiovascular events and rhTPO may produce immunogenicity. Currently, TPO-RA is recommended for the treatment of CIT by consensus guidelines at home and abroad. The study was designed to explore the safety and efficacy of Herombopag in the treatment of tumour-associated thrombocytopenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Age ≥18, no gender limitation;
- •Participants with solid tumors confirmed by histopathological or cytological examination;
- •During the current tumor treatment cycle, the participants whose PLT<50×109/L, and will receive the current tumor treatment regimen for at least 1 cycle;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •Voluntarily participated in the study and signed the informed consent with good compliance.
排除标准
- •Suffering from any of the following diseases of the hematopoietic system other than thrombocytopenia caused by tumor therapy, including but not limited to leukemia, primary immune thrombocytopenia, myeloid proliferative disease, multiple myeloma and myelodysplastic syndrome;
- •Suffering from thrombocytopenia (not caused by tumor treatment), including but not limited to chronic liver disease, hypersplenism, infection, and bleeding, within 6 months prior to screening;
- •Bone marrow invasion or bone marrow metastasis;
- •Received radiation therapy to the pelvis, spine and bone field within 3 months prior to screening; or is/is expected to receive radiation therapy.
- •Received TPO-RA drugs (such as altrepopal and romistine), or rhTPO or rhIL-11 in the current cancer treatment cycle;
- •Received platelet transfusion within 3 days prior to randomization;
- •Participants with known or expected allergy or intolerance to the active ingredient or excipient of Herombopag Olamine tablets;
- •Pregnant or lactating women;
- •Participants who are participating in other clinical trials.
- •Other conditions that the investigator determines are not suitable for inclusion in the study.
研究组 & 干预措施
Herombopag monotherapy
干预措施: TPO-RA (Herombopag) (Drug)
Herombopag is treated in combination with rhTPO(Recombinant human thrombopoietin)
干预措施: TPO-RA (Herombopag) and rhTPO(Recombinant human thrombopoietin) (Drug)
结局指标
主要结局
During the correction period, the percentage of patients whose platelets returned to normal within 14 days
时间窗: up to 14 days
Percentage of patients whose platelets returned to normal within 14 days
次要结局
- During the correction period, the median time for platelet values to return to normal(up to 60 days)
- During the correction period, the Median time for platelet count to return to 75×109/L(up to 60 days)
- During the correction period, the percentage of patients whose platelets returned to75×109/L within 14 days(up to 14 days)
- During the correction period, platelet infusion rate after initiation of Herombopag therapy.(up to 14 days)
- During the prophylaxis period, the proportion of patients whose PLT<75×109/L(up to 14 days)
- During the prophylaxis period, the proportion of patients whose PLT<50×109/L(up to 14 days)
- During the prophylaxis period, platelet counts are at their lowest.(up to 14 days)
- During the prophylaxis period, platelet infusion rate after initiation of Herombopag therapy.(up to 14 days)
- Platelet value curve(up to 60 days)
- During the correction period, the median time for platelet count to return to 50×109/L(up to 60 days)
- During the correction period, the percentage of patients whose platelets returned to 50×109/L within 14 days(up to 14 days)
研究者
Hong Zong
The First Affiliated Hospital of Zhengzhou University, Oncology Department， Chief Physician
The First Affiliated Hospital of Zhengzhou University