The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients

Inclusion Criteria:

1. Age 18-75 years;
2. Ovarian cancer patients using niraparib as maintenance therapy;
3. Estimated survival≥ 12 weeks;
4. Eastern Cooperative Oncology Group Physical Score(ECOG PS) : 0-2;
5. 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:

1. Patients with the following hematopoietic system diseases: leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome, etc;
2. Thrombocytopenia caused by non-anti-tumor therapy within 6 months before screening, including chronic liver disease, hypersplenism, infection and bleeding, etc;
3. 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;
4. Patients with antiphospholipid syndrome;
5. Platelet transfusion or used TPO-RA, rhTPO and other platelet-raising drugs within 3 days before screening;
6. Patients with known or expected hypersensitivity or intolerance to the active ingredient or excipients of Hetrombopag