Rare tumors
Conditions
Interventions
experimental group:Start taking Hetrombopag 7.5mg/day from Day 1 after chemotherapy, continue for 14 days, or until the stopping criteria are met (you can consider stopping once platelets rise to =200
Sponsors
The Afliated Cancer Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with rare tumors diagnosed by histopathology; 2. Age: 18-75 years old; 3. ECOG score: 0-2; 4. At least need to have received >= 1 cycle of chemotherapy; 5. Platelet count = 100 x 10^9/L before treatment in this cycle; 6. The values of the laboratory tests conducted during the screening need to meet the following standards: (1) Blood routine examination: a) Hemoglobin (HB) >= 90 g/L; b) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; c) Platelet count (PLT) >= 80 x 10^9/L; (2) Biochemical examination: a) AST and ALT = 60 mL/min (Cockcroft-Gault formula); 7. The investigator determines that the patient can receive eculizumab treatment.
Exclusion criteria
Exclusion criteria: If the subjects have any of the following characteristics or conditions, they will not be eligible to participate in this study: 1. Pregnant or lactating women; 2. Unable to understand the nature of the study or have not given informed consent; 3. Have experienced any arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), or have clinical symptoms and medical history suggesting thrombophilia; 4. Had a heart disease within 3 months before screening, including grade 3/4 congestive heart failure, arrhythmia requiring medication, myocardial infarction, or known arrhythmias that increase the risk of thrombotic events (such as atrial fibrillation), or if the corrected QT interval (QTc) of the subject is prolonged; 5. Platelet reduction caused by chemotherapy alone (such as chronic liver disease, sepsis, disseminated intravascular coagulation, immune thrombocytopenia, etc.); 6. Known to be allergic to TPO-RA class drugs; 7. Have severe bleeding symptoms; 8. Are using other drugs that may affect platelet count (traditional Chinese medicine, platelet-stimulating drugs, antiplatelet drugs, etc.); 9. The investigator determines that there are other circumstances that make them unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of PLT < 50 × 10^9/L during this treatment cycle; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of grade 2 or higher thrombocytopenia;Nadir of platelet count;Time from platelet count nadir to recovery to =100 × 10^9/L;Duration of grade 3 or higher thrombocytopenia;Platelet count on the day before the next cycle of chemotherapy;Proportion of patients with delay, dose reduction, suspension, or regimen adjustment of anti-tumor therapy in the next cycle due to thrombocytopenia;Proportion of patients receiving rescue therapy;Frequency and volume of platelet transfusions;Side effects; | — |
Countries
China
Contacts
Public ContactDongyuan Zhu
The Affiliated Cancer Hospital of ShandongFirst Medical University
Outcome results
None listed