Herombopag for Chemotherapy-induced Thrombocytopenia: a Prospective Multi-center One-arm Study in Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes of the platelet counts after the treatment of Herombopag at week 12
研究概览
简要总结
To evaluate the efficacy and safety of Herombopag to treat chemotherapy-induced thrombocytopenia in Solid Tumors
详细描述
The investigator had registered a clinical trial of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia（NCT04600960）. Due to the late launch of Herombopag in China, the investigator also collected the information of Herombopag in the treatment of chemotherapy-induced thrombocytopenia according to the protocal of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia（NCT04600960）.
This is a single-arm study to evaluate the safety and efficacy of Herombopag to treat chemotherapy-induced thrombocytopenia（CIT）. These subjects have been treated with recombinant human thrombopoietin（rhTPO） or interleukin 11（IL-11） before, the platelets can rise to normal or reach the effective standard, but after the re-application, the effective standard is not reached, or the effective standard is still not reached after the rhTPO 300U/kg/d treatment for 14 days. The investigator will assess the changes of the platelet counts after the treatment of Herombopag from week 1 to week 24, and observe incidence of adverse events during the treatment of Herombopag. The investigator will complete the 4 weeks safety visits（once a week），if the subjects end or withdraw from the clinical trial.
Patients with chemotherapy-induced thrombocytopenia who had the same inclusion and exclusion criteria in the same period or in the past will be compared with the efficacy and safety of supportive treatment and Eltrombopag or Avatrombopag treatment in the same period or history, so as to preliminarily explore and evaluate the efficacy and safety of Herombopag treatment.
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
- •Aged ≥18 years old, male or female;
- •Conform to the diagnostic criteria of chemotherapy-induced thrombocytopenia (CIT); Ineffective after repeated treatment with rhTPO or IL-11；
- •Stop radiotherapy or chemotherapy for more than 1 month;
- •Platelet counts <30 ×10^9/L, and bleeding tendency;
- •Estimated survival period ≥ 6 months；
- •People who are willing to sign the informed consent voluntarily and follow the research program.
- •Liver and kidney function<1.5×upper limit of normal, qualified for physical examination；
- •Subject is practicing an acceptable method of contraception. Women of childbearing potential must have a negative serum pregnancy test in the whole study;
排除标准
- •Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases；
- •Patients with poor compliance;
- •Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;
- •Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.
- •There is currently a heart disease requiring treatment or a poorly controlled hypertension judged by the investigator；
- •Patients with thrombotic diseases such as pulmonary embolism, thrombosis, and atherosclerosis；
- •Those who have received allogeneic stem cell transplantation or organ transplantation in the past；
- •Patients with mental disorders who cannot normally obtain informed consent and undergo trials and follow-up；
- •Patients whose toxic symptoms caused by treatment before participating in the trial have not disappeared；
- •Other serious diseases that may restrict participants from participating in this trial (such as diabetes; severe heart failure; myocardial obstruction or unstable arrhythmia or unstable angina in the past 6 months; gastric ulcers; mobility Autoimmune diseases, etc.)；
- •Patients with sepsis or patients with other irregular bleeding；
- •Patients taking antiplatelet drugs at the same time；
- •Pregnant women, suspected pregnancy (a positive pregnancy test for human chorionic gonadotropin in urine at screening) and breastfeeding patients；
- •Pre-existing cardiac disease, including congestive heart failure of New York Heart Association [NYHA] Grade III/IV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT >450msec or QTc > 480 for patients with a Bundle Branch Block;
- •Researchers believe that patients should not participate in the test of any other condition.
研究组 & 干预措施
50 subjects with chemotherapy-induced thrombocytopenia
50 enrolled subjects will be picked up to take Herombopag at the indicated dose.
干预措施: Herombopag (Drug)
结局指标
主要结局
Changes of the platelet counts after the treatment of Herombopag at week 12
时间窗: 12 weeks
The investigator will assess the changes of the platelet counts after the treatment of Herombopag from week 1 to week 24，and calculate the proportion of subjects ≥ 30 × 10\^9/L ， 50 × 10\^9/L and 100 × 10\^9/L at week 12.
Changes of the platelet counts after the treatment of Herombopag at week 24
时间窗: 24 weeks
The investigator will assess the changes of the platelet counts after the treatment of Herombopag from week 1 to week 24，and calculate the proportion of subjects ≥ 30 × 10\^9/L ， 50 × 10\^9/L and 100 × 10\^9/L at week 24.
次要结局
- Incidence of adverse events after the treatment of Herombopag(24 weeks)
- Changes of concentration of TPO in peripheral blood(24 weeks)
- Changes of concentration of TPO antibodies，anti-c-Mpl antibodies and TPO neutralizing antibodies in peripheral blood(24 weeks)