Chemotherapy-induced thrombocytopenia
Conditions
Interventions
Experimental group:Romiplostim administered by subcutaneous injection
Control group:Oral administration of Avatrombopag
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 = 4 cycles of platinum-containing adjuvant chemotherapy or ADC drug therapy, and platelet = 70; 5. Expected survival period of more than 3 months; 6. There are no other causes of thrombocytopenia, such as infection, non-chemotherapy drugs (including heparin-induced thrombocytopenia), severe liver disease, tabes dorsalis, thrombotic microangiopathy, immune thrombocytopenia, disseminated intravascular coagulation, etc; 7. The indexes of ALT, AST and TBIL in liver function test were within 2.5 times of the upper limit of normal value; 8. Renal function tests showed that BUN and Cr were within 1.5 times of the upper limit of normal value; 9. Cardiac function: LVEF >= 55% by two-dimensional echocardiography; 10. No history of serious systemic diseases; 11. Women of childbearing age who have a negative serum or urine pregnancy test before the start of treatment and who agree to use contraception during treatment; 12. The patient (or legal representative) signs the informed consent.
Exclusion criteria
Exclusion criteria: 1. Have received systemic or local cancer treatment, including chemotherapy, radiotherapy and endocrine therapy; 2. Have had malignant tumors within five years (except curable basal cell carcinoma of the skin and cervical cancer); 3. Patients have participated in other clinical trials or used other investigational drugs 30 days before enrollment; 4. Patients with uncontrolled heart and lung diseases, severe infections, liver diseases requiring treatment, active gastrointestinal ulcers, coagulation disorders, severe uncontrolled diabetes, connective tissue diseases or bone marrow suppression can not tolerate chemotherapy-related treatment; 5. Patients with strong thrombotic tendency or history of major thromboembolism, such as triple positive antiphospholipid antibody syndrome and history of multiple recurrent arteriovenous thromboembolism; 6. Combined with other hematological diseases; 7. Severe hepatic and renal insufficiency; 8. Known hypersensitivity to the drug used; 9. LVEF detected by two-dimensional echocardiography < 55%; 10. Severe cardiovascular and cerebrovascular diseases (such as unstable angina pectoris, chronic heart failure, hypertension, myocardial infarction or cerebrovascular accident) within six months before randomization; 11. Refusal of contraception by women of childbearing age during treatment and for eight weeks after the end of treatment; 12. Pregnant and lactating women; 13. Mental illness, cognitive impairment, inability to understand the test plan and side effects, inability to complete the test plan and follow-up workers; 14. Lack of personal freedom and independent civil capacity (systematic evaluation is required before the trial is enrolled); 15. The investigator determined that long-term follow-up data were not available for the patient (due to unavailability or severe concomitant disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time for the patient's platelet count to rise to >=75×10^9/L after medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions;Incidence of clinical bleeding events;The duration for which the patient's platelet count can be maintained at >=75×10^9/L after medication; | — |
Countries
China
Contacts
Public ContactWang Jue
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed