Gastrointestinal tumor patients with thrombocytopenia due to chemotherapy
Conditions
Interventions
Test group:Hetrombopag by Oral administration
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Patients with confirmed digestive tract tumors (including esophageal cancer, gastric cancer, and colorectal cancer, etc.); 3. In the previous chemotherapy cycle (Cycle N-1), the patient's lowest peripheral blood platelet count was >=75×10?/L, and at least one of the following high-risk factors for bleeding was present: A history of previous bleeding; Previous treatment with platinum-based drugs, gemcitabine, cytarabine, anthracyclines, or other similar agents; Bone marrow infiltration by tumor cells; Previous or ongoing radiotherapy, especially involving long bones or flat bones (such as the pelvis, sternum, etc.). 4. In the current treatment cycle (Cycle N), the patient's peripheral blood platelet count is >=100+/-25×10?/L. 5. Are receiving treatment in 14-day or 21-day cycles and need to receive at least 1 more cycle of treatment; 6. ECOG score :0-2; 7. Adequate hematopoietic, liver and kidney function; Neutrophil count >=1.5x10^9/L Hemoglobin >=9.0g/dL; Creatinine clearance =40mL/min(Cockcroft-Gault formula) In patients without liver metastasis AST and ALT<=2.5 times the upper limit of normal values; Bilirubin <=2 times the upper limit of normal value; APTT, PT<=1.5 times the upper limit of normal value; 8. Sign informed consent;
Exclusion criteria
Exclusion criteria: 1. Previous use of TPO-RA drugs; 2. Before treatment, he suffered from diseases such as hypersplenia, immune thrombocytopenia, etc; 3. History of thrombosis; 4. Have a blood disease (anemia, leukemia, autoimmune hemolytic disease, etc.); 5. Have major cardiovascular disease (acute myocardial infarction, cerebral thrombosis, cerebral hemorrhage, etc.); 6. Pregnant and lactating women; 7. Participants in clinical trials of other drugs within 4 weeks; 8. Poor compliance, inability to cooperate with and describe treatment responders; 9. Other antiplatelet or platelet enhancing drugs, including Chinese medicines and proprietary Chinese medicines, are required;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood platelet count; | — |
Countries
China
Contacts
Public ContactXianbao Zhan
Shanghai Changhai Hospital
Outcome results
None listed