Chemotherapy-induced thrombocytopenia in children with solid tumors
Conditions
Interventions
experimental group:Oral administration of hetrombopag was started 24 h after the initiation of antineoplastic therapy in this cycle. The starting dose was 2.5 mg/d for patients aged 1-5 years, 5mg/d f
Sponsors
Shanghai Children's Medical Center Affiliated to Medical College of Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: To be enrolled in the study, subjects had to meet all of the following eligibility criteria: 1. 1 = age < 18 years old, regardless of gender; 2. Patients with standard risk/high risk medulloblastoma, pineoblastoma and high risk neuroblastoma confirmed by histopathology; 3. The lowest platelet count in the last chemotherapy cycle was less than 50×109/L; 4. ECOG PS score =2; 5. Predicted survival time =12 weeks; 6. Subjects and their legal guardians agreed to participate and signed an informed consent form.
Exclusion criteria
Exclusion criteria: Patients with any of the following were not eligible for the study: 1. Inability to understand the nature of the study or lack of informed consent; 2. Patients with uncontrolled bleeding and/or infection after standard treatment before enrollment; 3. Suffering from the following hematopoietic system diseases other than anti-tumor therapy-induced thrombocytopenia (CTIT), including but not limited to bone marrow failure syndrome (BMFS), leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, and myelodysplastic syndrome; 4. Significantly abnormal liver and kidney function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) more than 2.5 times of the upper limit of normal value, total bilirubin more than 1.5 times of the upper limit of normal value, serum creatinine more than 1.5 times of the upper limit of normal value; 5. History of liver cirrhosis or portal hypertension; 6. Congestive heart failure, arrhythmia, peripheral arteriovenous thrombosis requiring medical treatment within 1 year before enrollment, or myocardial or cerebral infarction within 3 months before enrollment; 7. Use of other targeted drugs during treatment; 8. Other conditions judged by the investigator to be unsuitable for inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade 3/4 thrombocytopenia ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in platelet count during treatment; ;Minimum values of platelet count decline after tumour treatment;Median time for PLT to recover to =50×109/L, 75×109/L, and 100×109/L via nadir;Duration of grade 3/4 thrombocytopenia;Platelet transfusion status; | — |
Countries
China
Contacts
Public ContactZhang Anan
Shanghai Children's Medical Center Affiliated to Medical College of Shanghai Jiaotong University
Outcome results
None listed