Thrombocytopenia due to tumor chemotherapy
Conditions
Interventions
Experimental group:Medication Intervention of Herombopag Olamine Tablets
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, no gender limit; 2. Patients with malignant tumors diagnosed by histopathological or cytological examination, regardless of the type of cancer, with thrombocytopenia during tumor treatment; 3. Platelet count = 12 weeks; 5. ECOG PS score of physical condition: 0-2 points; 6. Laboratory inspection indicators meet the following requirements: (1) Renal function: Cr=55 ml/min; (2) Liver function: total bilirubin38?; 11. Those who are expected to have good compliance can follow up the efficacy and adverse reactions according to the program requirements.
Exclusion criteria
Exclusion criteria: 1. Thrombocytopenia caused by non-tumor therapy within 6 months before screening, including but not limited to liver cirrhosis, hypersplenism, infection, and bleeding; 2. Suffering from other hematopoietic system diseases other than thrombocytopenia caused by malignant tumor chemotherapy, including leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome, etc. ; 3. Combined with bone marrow invasion or bone marrow metastasis; 4. Received pelvic and spine radiotherapy and bone field irradiation within 3 months before screening; 5. Any history of arterial or venous thrombosis within 6 months before screening; 6. Clinical manifestations of severe bleeding (such as gastrointestinal bleeding, etc.) within 2 weeks before screening; 7. Received platelet transfusion within 2 days before enrollment; 8. Severe cardiovascular disease (such as NYHA cardiac function score III-IV) within 6 months before screening, arrhythmias known to increase the risk of thromboembolism such as atrial fibrillation, coronary stenting, angioplasty patients after coronary artery bypass grafting and coronary artery bypass grafting; 9. Received human recombinant thrombopoietin (rhTPO) or human recombinant interleukin-11 (rhIL-11) or thrombopoietin receptor agonist drugs within 10 days before screening (aitripoppa, avatripoppa) treatment; 10. Patients with known or expected hypersensitivity or intolerance to the active ingredients or excipients of Hetrombopag Tablets (excipients include: cellulose-lactose, low-substituted hydroxypropyl cellulose, magnesium stearate, film-coated premix) agent); 11. Pregnant or lactating patients; 12. Those deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time required for platelet count to recover from nadir to >=100x10^9/L during treatment phase; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients whose platelet counts recovered to >=100x10^9/L during the treatment period;Minimum platelet count during the treatment phase;Minimum platelet count during maintenance phase;Proportion of oncology chemotherapy suspensions due to thrombocytopenia;Number and volume of platelet transfusions;Safety and tolerability of Herombopag Olamine Tablets; | — |
Countries
China
Contacts
Public ContactChen Lu
Zhejiang Cancer Hospital
Outcome results
None listed