thrombocytopenia after chemotherapy for gynecological malignant tumors
Conditions
Interventions
rh-TPO monotherapy:rh-TPO 15000U, qd
until the platelet count returns to normal
Hetrombopag ethanolamine tablet single drug:Hetrombopag ethanolamine tablets 5mg qd
until platelet count returns to normal
Hetrombopag ethanolamine tablets combined with rh-TPO:Hetrombopag ethanolamine tablets 5mg qd + rh-TPO 15000U, qd
Sponsors
Xiangyang Central Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with gynecological malignancies; 2. CIT patients: peripheral blood platelet counts below 100 x 10^9/L after the use of antitumor chemotherapy drugs; 3. Women aged 18-75 years at the time of the visit; 4. With platelet count < 75 x 10^9/L on the day before or on the day of enrollment; 5. Who did not participate in any clinical research within 4 weeks before enrollment; 6. Who are willing to participate in this research.
Exclusion criteria
Exclusion criteria: 1. Screening or baseline platelet value < 20 x 10^9/L; 2. Thrombocytopenia caused by non-tumor therapy within 6 months before screening, including but not limited to liver cirrhosis, hypersplenism, infection, and bleeding; 3. Suffering from other hematopoietic system diseases other than thrombocytopenia caused by concurrent radiotherapy and chemotherapy of malignant tumors, including leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome; 4. Combined with bone marrow invasion or bone marrow metastasis; 5. After treatment with red blood cells or erythropoietin (EPO), hemoglobin is still < 80g/L, or after treatment with granulocyte colony-stimulating factor (G-CSF), the absolute value of neutrophils is still < 1.0 x 10^9 /L; 6. Received pelvic and spine radiotherapy and bone field irradiation within 3 months before screening; 7. Any history of arterial or venous thrombosis within 6 months before screening; 8. Clinical manifestations of severe bleeding (such as gastrointestinal bleeding, etc.) within 2 weeks before screening; 9. Received platelet transfusion within 2 days before enrollment; 10. Severe cardiovascular disease (such as NYHA cardiac function score III-IV) within 6 months before screening, arrhythmia 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; 11. Received human recombinant thrombopoietin (rhTPO) or human recombinant interleukin-11 (rhIL-11) or thrombopoietin receptor agonist drugs (such as eltrombopag, avatropol within 14 days before screening) treatment; 12. Patients with known or expected hypersensitivity or intolerance to the active ingredients or excipients of hetrombopag ethanolamine tablets (excipients include: cellulose-lactose, low-substituted hydroxypropyl cellulose, magnesium stearate, film-coating premixed agent); 13. Lactating women; 14. Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, pregnant women, etc.; 15. Those who are deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients whose platelet counts recovered to >= 100 x 10^9/L during the treatment period;Time required for platelet count to recover to >= 100 x 10^9/L during treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The lowest platelet count in the treatment phase;Time to maintain platelet count >= 100 x 10^9/L during treatment;The difference in platelet counts at the end of the treatment period and at the beginning of chemotherapy;Percentage of concurrent chemotherapy pauses due to thrombocytopenia; | — |
Countries
China
Contacts
Public ContactXiaomin Qin
Xiangyang Central Hospital
Outcome results
None listed