Cancer therapy induced thrombocytopenia,CTIT
Conditions
Interventions
Experimental group:Romiplostim administered by subcutaneous injection
Control group:rhTPO administered by subcutaneous injection
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female, 18 years old = 4 cycles is less than 50 × 10^9/L; 5. Physical condition (KPS) score >= 70 points; 6. Expected survival period of more than 3 months; 7. The liver function test showed that all indicators of ALT, AST, and TBIL were within 2.5 times the upper limit of normal values; 8. The BUN and Cr levels in renal function tests are within 1.5 times the upper limit of normal values; 9. Cardiac function: Two dimensional echocardiography with LVEF >= 55%; 10. Women of childbearing age who have a negative serum or urine pregnancy test before the start of treatment and agree to take contraceptive measures during the treatment period; 11. Patient (or legal representative) signs informed consent form.
Exclusion criteria
Exclusion criteria: 1. Received systemic or local tumor treatment, including chemotherapy, radiotherapy, and endocrine therapy; 2. History of malignant tumors within five years (excluding cured non melanoma skin cancer, cervical cancer, or malignant tumors that have been cured for >= 3 years and have a low risk of recurrence); 3. Have participated in other clinical trials or used other investigational drugs within 30 days prior to enrollment; 4. Suffering from hematological malignancies or other hematological diseases, such as acute lymphoblastic leukemia, acute myeloid leukemia, any myeloid malignancy, myelodysplastic syndrome (MDS), aplastic anemia, immune thrombocytopenia, disseminated intravascular coagulation, splenic hyperfunction, myeloproliferative disorders, multiple myeloma, etc.; 5. Accompanied with uncontrolled heart and lung disease, severe infection or active infection, severe liver and kidney insufficiency, liver disease requiring treatment, active gastrointestinal ulcer, coagulation disorder, severe uncontrolled diabetes, connective tissue disease or bone marrow function depression, and unable to tolerate chemotherapy related treatment; 6. Used non anti-tumor drugs (including chemotherapy, targeted therapy, immunotherapy, etc.) that can cause thrombocytopenia, such as heparin, sulfonamide drugs, or used anticoagulant ethylenediaminetetraacetic acid (EDTA) that can cause pseudothrombocytopenia; 7. Patients with a strong tendency towards thrombosis or a history of significant thromboembolism, such as those with triple positive antiphospholipid antibody syndrome or a history of multiple recurrent arteriovenous thromboembolism; 8. New or uncontrolled venous thromboembolism or thrombotic events within the past 3 months (excluding patients who have received anticoagulant therapy for at least 14 days, have stable conditions, and can continue anticoagulation in the study); 9. History of arterial thrombosis in the past 6 months, such as cerebral infarction, heart attack, transient ischemic attack, etc.; 10. Active hepatitis B/C or HIV; 11. Known to be allergic to the medication used; 12. Previous use of TPO receptor agonists (to ensure efficacy for first-time use); 13. Refusing contraception during and within eight weeks after treatment for women of childbearing age; 14. Pregnant and lactating women; 15. Having mental illness, cognitive impairment, inability to understand testing plans and side effects, inability to complete testing plans and follow-up; 16. Lack of personal freedom and independent civil capacity (systematic evaluation is required before enrollment in the trial); 17. Researchers have determined that patients cannot obtain long-term follow-up data (due to unavailability or severe comorbidities).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time when the platelet count increases to >=100 × 10^9/L or increases by >50 × 10^9/L compared to before.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Incidence of clinical bleeding events of Grade = 2;Proportion of patients with platelet count < 75 × 10?/L after prophylactic treatment; | — |
Countries
China
Contacts
Public ContactWang Jue
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed