Thrombocytopenia
Conditions
Interventions
Hetrombopag:Hetrombopag
Sponsors
Shandong Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, age =18 years at screening. 2. Histologically or cytologically confirmed solid tumor, including lung cancer (small cell lung cancer, non-small cell lung cancer), esophageal cancer, cervical cancer, etc. 3. Receiving radiotherapy alone or in combination with other antitumor therapies (including concurrent chemoradiotherapy, sequential chemoradiotherapy, radiotherapy combined with other anti-tumor treatments, etc.) and experiencing thrombocytopenia defined as PLT3 months at screening. 6. Agreement for subjects of childbearing potential to take effective contraceptive measures throughout the study (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive diaphragm, contraceptive cream, contraceptive suppository, abstinence, and inserted intrauterine devices, etc.); except female subjects who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation or have been in menopause for more than 1 year, and male subjects who have undergone bilateral vasectomy or ligation. 7. Signed ICF for voluntary participation in the study and good compliance.
Exclusion criteria
Exclusion criteria: 1. Known or expected allergy or intolerance to the active substances or excipients of hetrombopag. 2. Thrombocytopenia caused by reasons other than CTIT, including hematopoietic diseases (leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndromes, etc.), chronic liver disease, hypersplenism, infection and hemorrhage, etc. 3. History of arterial or venous thrombosis within 6 months prior to the screening period; 4. Severe cardiovascular disorders or interventions within 6 months before screening: New York Heart Association (NYHA) Class III-IV; arrhythmias known to increase the risk of thromboembolism (e.g., atrial fibrillation, coronary artery angioplasty, stenting, or bypass grafting, etc.). 5. Clinical manifestations of severe bleeding, such as gastrointestinal or central nervous system bleeding, within 2 weeks before the screening period. 6. Received thrombopoietin receptor agonist drugs (such as eltrombopag, roproxitim) within 1 month before the screening period. 7. Platelet transfusion within 3 days prior to the first dose. 8. Obvious abnormalities in liver and kidney function: ALT/AST>3ULN (upper limit of normal), TBIL>3ULN, serum creatinine =1.5ULN. 9. Human immunodeficiency virus (HIV) infection. 10. Pregnancy/intention to become pregnant during the study period or lactation. 11. Other conditions judged by the investigator to be unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of treatment responders; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in platelet count during treatment;Proportion of subjects achieving PLT=75×10^9/L within 14 days;Time duration of PLT to recover to =75×10^9/L and 100×10^9/L during treatment;Proportion of subjects with chemotherapy regimen modifications due to thrombocytopenia;Proportion of subjects with platelet transfusion;Proportion of subjects with bleeding events (according to the World Health Organization (WHO) bleeding scale);Adverse Events; | — |
Countries
China
Contacts
Public ContactXing Ligang
Shandong Cancer Hospital & Institute
Outcome results
None listed