Chemotherapy induced thrombocytopenia
Conditions
Interventions
Group 1:Ettrappa 50mg orally once a day
Group 2:Ettrabopa 100mg orally once a day
Sponsors
Hangzhou First People's Hospital Affiliated to Medical College of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18 or above at the time of signing the informed consent; 2. Patients diagnosed as lymphoma or solid tumor (including NSCLC, breast cancer, bladder cancer, pancreatic cancer, etc.) by histopathological or cytological examination, the chemotherapy cycle is 21 days or 28 days, and one or more of the following chemotherapy drugs are needed: anti metabolic drugs, including gemcitabine, etc.; platinum, including carboplatin, nedaplatin, cisplatin, lobaplatin, etc.; anthracycline, including adriamycin, cisplatin, cisplatin, etc Other cytotoxic chemotherapeutic agents, such as daunorubicin and epirubicin, alkylating agents, including cyclophosphamide and ifosfamide, can cause thrombocytopenia; 3. In the previous regular chemotherapy, the platelet count was lower than 75 x 10^9 / L; 4. Patients with any one of the high risk factors of bleeding; (1) patients with previous bleeding history, such as gastrointestinal ulcer bleeding, cerebral hemorrhage, etc., and at present, patients with surgical incision failure, tumor ulcer, etc.; (2) patients with platelet count less than 75 x 10^9 / L before chemotherapy; (3) patients receiving platinum, gemcitabine, and chemotherapy There are four main causes of bone marrow suppression: cytosine arabinoside and anthracycline; (4) thrombocytopenia caused by tumor cells infiltrating bone marrow; (5) Eastern Cooperative Oncology Group (ECoG) score >= 2; (6) radiotherapy, especially for long bones and flat bones (e.g. pelvis, tibia, tibia, etc.) (7) combined use of other drugs that may cause thrombocytopenia, such as heparin, antibiotics, etc.) 5. Subjects with platelet count less than 100 x 10 ^ 9 / L one day before medication; 6. Patients with at least 3 cycles of chemotherapy at the time of enrollment; 7. According to the ECoG score of 0-2; 8. Patients who fully understand and comply with the requirements of this study and sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Patients with hematopoietic system diseases other than lymphoma and chemotherapy-induced thrombocytopenia (CIT), including leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome, etc; 2. Screening of patients with thrombocytopenia caused by non tumor chemotherapy drugs in the first 6 months, including but not limited to EDTA dependent pseudothrombocytopenia, hypersplenism, infection and bleeding; 3. Patients who have received large area radiotherapy or are receiving radiotherapy in the past; 4. There were any arterial or venous thrombosis events within 6 months before screening; 5. Patients with active congestive heart failure in the first 4 months were screened (NYHA heart function score III-IV); 6. Screening the patients with severe bleeding in the first two weeks (such as gastrointestinal bleeding, etc.); 7. Patients who had received platelet transfusion within 2 days before randomization; 8. Patients with chronic hepatitis B or hepatitis C in active stage, and patients with positive human immunodeficiency virus antibody; 9. The absolute value of neutrophils was less than 1.5 x 10^9 / L and hemoglobin was less than 90g / L in screening period; 10. Patients with total bilirubin > 3 times of the upper limit of the normal range; patients with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 3 times of the upper limit of the normal range; patients with liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >= 5 times of the upper limit of the normal range; 11. Patients with creatinine clearance rate less than 30ml / min in screening period; 12. Patients with severe drug allergic reaction; 13. Patients who participated in the clinical study of other drugs (excluding vitamins and minerals) within 3 months before the first administration; 14. Patients with planned pregnancy, pregnancy or lactation; 15. Fertile subjects who were judged by the researchers as not using adequate contraceptive measures; 16. Patients judged by the researcher not suitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lowest platelet count after chemotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Highest platelet count after chemotherapy;The duration time of platelets < 100x10^9/ L;The duration time of platelets < 50x10^9/ L;The duration time of platelets < 30x10^9/ L;Platelet recovery time; | — |
Countries
China
Contacts
Public ContactShenxian Qian
Hangzhou First People's Hospital Affiliated to Medical College of Zhejiang University
Outcome results
None listed