CANCER THERAPY INDUCED THROMBOCYTOPENIA
Conditions
Interventions
Group A:For ctit patients with platelet counts >=50×10^9/L and =75×10^9/L.
Group B:For CTIT patients with platelet counts below 50×10^9/L, they were assigned to Group B, where combination therapy with TPO and TPO-RA was administered until platelet counts increased to >=75×10
Sponsors
Affiliated Jinhua Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be eligible for participation in this study. 1. Have an understanding of the study procedures, voluntarily sign the informed consent form, and be willing to participate in this study. 2. Be aged 18 years or above. 3.Have received anti - tumor treatments (including chemotherapy, targeted therapy, immunotherapy, etc.) within 14 days prior to the study lead - in period. 4. Undergo anti - tumor treatment (for specific treatment regimens, refer to the subsequent "Reference Regimens"). 5. Have platelet counts of less than 75×10?/L in two consecutive measurements taken more than 24 hours apart, with a 3 - day screening period.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from this study: 1. Previous administration of rhTPO or TPO-RA agents; 2. Prior enrollment in this study due to chemotherapy-induced thrombocytopenia (CTIT); 3. Concurrent participation in another interventional clinical trial; 4. History of hematologic malignancies, including leukemia, myeloma, myeloproliferative disorders, lymphoma, or myelodysplastic syndromes; 5. Patients with underlying hepatic conditions (e.g., cirrhosis or chronic hepatitis) without primary or metastatic liver cancer will be excluded if ALT/AST levels exceed 3 times the upper limit of normal (ULN) or total bilirubin exceeds 3×ULN; 6. Patients with primary or metastatic liver cancer will be excluded if ALT/AST levels exceed 5×ULN or total bilirubin exceeds 5×ULN; 7. History of symptomatic venous thromboembolic events (e.g., deep vein thrombosis or pulmonary embolism) or symptomatic arterial thromboembolic events (e.g., myocardial infarction, ischemic cerebrovascular accident, or transient ischemic attack) with intolerance to anticoagulant therapy; patients with D-dimer levels exceeding 10,000 µg/L will also be excluded; 8. Severe comorbidities that may interfere with trial conduct, such as unstable angina, renal failure requiring hemodialysis, or active infections necessitating intravenous antibiotics; 9. Pregnant or lactating women, and patients unwilling to use contraception; 10. Inability to comprehend the study's nature or failure to provide informed consent; 11. Other conditions deemed by the investigator as unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time required for platelet count to increase from nadir to 75×10^9/L; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time required for platelet count to increase from nadir to 100×10^9/L; | — |
Countries
China
Contacts
Public ContactJianfei fu
Affiliated Jinhua Hospital of Zhejiang University School of Medicine
Outcome results
None listed