the treatment of cancer therapy-induced thrombocytopenia
Conditions
Interventions
experimental group:Herombopag Olamine Tablets combined with caffeic acid tablets for the treatment of CTIT,Hettropopa ethanolamine tablets: 5mg/ time, once a day, for no more than 14 days
Caffeic acid tablets: 0.3g/ time, three times a day, and continuous medication for no more than 14 days.
Sponsors
Zhongshan Hospital Affiliated to Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Patients must meet all of the following inclusion criteria to be enrolled in this study: 1. aged 18-75 years old 2. Diagnosed with malignant tumor and receiving chemotherapy, radiotherapy, immunotherapy, targeted therapy, etc. chemotherapy, radiotherapy, immunotherapy, targeted therapy and other anti-tumor treatments. 3. ECOG score 0 2 4. have oncology-induced thrombocytopenia with a platelet count of 75 × 10 9 /L. 75 × 10 9 /L 5. Expected survival at screening is =12 weeks and can receive at least 1 cycle of current antitumor regimen for at least 1 week. Subjects are expected to survive =12 weeks at screening and can be treated with their current antitumor regimen for at least 1 cycle 2: 6. subjects of childbearing potential who agree to use reliable contraception (either male or female) throughout the study period. 6. subjects of childbearing potential who agree to use reliable contraception throughout the study period (including male or female condoms, contraceptive foams, contraceptive gels, (including male or female condoms, foams, gums, diaphragms, creams, suppositories, abstinence, and IUDs) throughout the study period 3: have undergone hysterectomy (including male or female condoms, contraceptive foams, diaphragms, creams, suppositories, abstinence, and IUD placement) 4: and Female subjects who have undergone hysterectomy, bilateral salpingo-oophorectomy, bilateral tubal ligation, or who have been postmenopausal for more than 1 year, and female subjects who have had bilateral Female subjects who have undergone hysterectomy, bilateral tubectomy, bilateral tubal ligation, or are more than 1 year postmenopausal and male subjects who have undergone bilateral vasectomy or ligation are excluded 7. voluntarily enroll in the study, sign the informed consent form, and have good compliance.
Exclusion criteria
Exclusion criteria: 1: Patients with any of the following conditions cannot be enrolled in this study: 1. screening or baseline platelet values = 10 x 109/L 2: 2. have any of the following hematopoietic disorders other than thrombocytopenia induced by oncology therapeutic agents (CTIT), including, but not limited to, leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, and myelodysplastic syndromes 3: 3. thrombocytopenia due to causes other than CTIT, including but not limited to chronic liver disease, hypersplenism, infections, and hemorrhage, within 6 months prior to screening 4: 4. bone marrow invasion or bone marrow metastasis 5: 5. radiotherapy to the pelvis, spine, and bone field within 3 months prior to screening, or current/expected radiotherapy 6: 6. a history of severe cardiovascular disease within 6 months prior to screening, e.g., congestive heart failure (NYHA Cardiac Function Score III-IV), cardiac arrhythmias such as atrial fibrillation that are known to increase the risk of thromboembolism, coronary stenting, angioplasty, and coronary bypass grafting 7: 7. history of any arterial or venous thrombosis within 6 months prior to screening 8: 8. clinical evidence of severe bleeding within 2 weeks prior to screening, e.g., gastrointestinal or central nervous system bleed, etc 9: 9. brain tumor or brain metastases 10: 10. absolute neutrophil value 3ULN (upper limit of normal), TBIL >3ULN 12: in patients with liver metastasis, ALT/AST =5ULN, TBIL =5ULN 13: 12. abnormal renal function: blood creatinine =1.5 ULN or eGFR =60 ml/min (Cockcroft-Gault formula) 14: 13. treatment with thrombopoietin receptor agonist analogs (e.g., eltrombopag, romiplostim), or human recombinant thrombopoietin (rhTPO), or recombinant human interleukin-11 (rhIL-11) within 1 month prior to screening 14. have received a platelet transfusion within 3 days prior to randomization 15: 15. patients with a known or anticipated allergy or intolerance to the active ingredient or excipients of Heptapeptoethylamine Tablets 16: 16. HIV-infected patients 17: 17. women who are pregnant or breastfeeding 18: 18. participation in any other clinical study of any other investigational drug or device in the 3 months prior to screening 19: 19. other conditions that, in the opinion of the investigator, make participation in the trial a greater risk to the health or safety of the subject or that may affect the assessment of efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time required to raise to target; | — |
Countries
China
Contacts
Public ContactLi Xiao
Zhongshan Hospital Affiliated to Xiamen University
Outcome results
None listed