The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients
Thrombocytopenia
About this trial
This is an interventional treatment trial for Thrombocytopenia focused on measuring Niraparib, Hetrombopag, Primary prevention
Eligibility Criteria
Inclusion Criteria: Age 18-75 years; Ovarian cancer patients using niraparib as maintenance therapy; Estimated survival≥ 12 weeks; Eastern Cooperative Oncology Group Physical Score(ECOG PS) : 0-2; Adequate function of organs: (1) Platelet count 100-300*109/L, neutrophil count≥2.0*109/L, hemoglobin 100-150g/L; (2) Renal function: Cr≤1.5 upper limit of normal(ULN); (3) Endogenous creatinine clearance (Ccr) ≥ 55 ml/min; (4) Liver function: total bilirubin ≤1.5 upper limit of normal(ULN); (5) Alanine aminotransferase(ALT)and aspartate aminotransferase(AST)≤3 upper limit of normal(ULN); (6) Coagulation function: PT≤1.5 upper limit of normal(ULN); 6. No serious complications (including active gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, non-cancerous fever> 38℃) Exclusion Criteria: Patients with the following hematopoietic system diseases: leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome, etc; Thrombocytopenia caused by non-anti-tumor therapy within 6 months before screening, including chronic liver disease, hypersplenism, infection and bleeding, etc; Imaging examination shows bone marrow invasion or bone marrow metastasis, such as Positron Emission Computed Tomography(PET-CT), Magnetic Resonance Imaging(MRI)or nuclear scan; Patients with antiphospholipid syndrome; Platelet transfusion or used TPO-RA, rhTPO and other platelet-raising drugs within 3 days before screening; Patients with known or expected hypersensitivity or intolerance to the active ingredient or excipients of Hetrombopag
Sites / Locations
Arms of the Study
Arm 1
Experimental
Hetrombopag
single-arm