chemotherapy-induced thrombocytopenia (CIT)
Conditions
Interventions
Hetrombopag Treatment Group:Herombopag Olamine Tablets (oral administration)
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, male or female. 2. Nasopharyngeal carcinoma confirmed by histopathology or cytology. 3. Presence of chemotherapy-induced thrombocytopenia (platelet count < 100×10?/L) in the current chemotherapy cycle. 4. ECOG performance status score of 0-2. 5. Receiving a 21-day cycle chemotherapy regimen for nasopharyngeal carcinoma (with or without radiotherapy), including but not limited to GP regimen, taxane plus platinum regimen, 5-FU plus platinum regimen, gemcitabine monotherapy, platinum-based concurrent chemoradiotherapy, etc. 6. Scheduled to receive at least one additional cycle of the same chemotherapy regimen; 7. Estimated overall survival = 12 weeks and eligible to receive at least one more cycle of the current chemotherapy regimen; 8. No participation in other investigational drug clinical trials within 4 weeks prior to enrollment; 9. Expected good compliance, able to complete follow-up for efficacy and adverse events in accordance with the study protocol; 10. Voluntary participation in this clinical trial, understanding the study procedures and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to thrombopoietin receptor agonists (TPO-RAs); 2. Complicated with diseases causing thrombocytopenia, such as aplastic anemia, primary immune thrombocytopenia, etc.; 3. Severe bleeding symptoms within the past 6 months, including upper gastrointestinal bleeding, bleeding in vital organs, intracranial hemorrhage, etc.; 4. Newly diagnosed thrombotic diseases within the past 6 months, such as cerebral infarction, arterial thrombosis, deep vein thrombosis, pulmonary embolism, etc.; 5. Patients with hypercoagulable state or disseminated intravascular coagulation (DIC); 6. Essential thrombocythemia. 7. Positive for anti-human immunodeficiency virus antibody or anti-treponema pallidum specific antibody. 8. Congestive heart failure with New York Heart Association (NYHA) functional class III or IV; 9. History of uncontrolled angina pectoris, myocardial infarction, or cerebral infarction within 6 months prior to screening. 10. Uncontrolled active infection. 11. History of rheumatic immune system diseases. 12. Pregnant or lactating women. 13. Any other conditions judged by the investigator to be inappropriate for study enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with effective treatment (Herombopag treatment response rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Nadir platelet count;Proportion of subjects requiring platelet rescue therapy;Duration of Grade 3 or higher thrombocytopenia;Duration of Grade 3 or higher thrombocytopenia;Incidence and severity of Adverse Events (AEs);Proportion of subjects with chemotherapy delay/dose reduction due to thrombocytopenia;Time to platelet recovery to =100×10?/L; | — |
Countries
China
Contacts
Public ContactLyu Xing
Sun Yat-sen University Cancer Center
Outcome results
None listed