ovarian cancer
Conditions
Interventions
single arm:Niraparib
Sponsors
Obstetrics & Gynecology Hospital of Fudan University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) The subject understands the test process, signs the informed consent and agrees to participate in the study; 2) Women aged 18 or above, 75 or below; 3) The ECOG body status score of the patient is 0-1; 4) Histologically confirmed epithelial ovarian cancer; 5) Subjects shall have measurable lesions confirmed by imaging, defined as at least one lesion, and accurately measured in at least one dimension (according to RECIST V1.1); 6) Subjects have received one previous platinum containing chemotherapy and disease progression within 6 months after the end of chemotherapy; 7) Life expectancy & GT;12 weeks; 8) Good organ and bone marrow function, including: Neutrophils count >= 1500/ L; Platelet p / 100000 (including L; Hemoglobin >= 10g/dL; Serum creatinine = 60mL/min (calculated according to Cockcroft-Gault formula); Total bilirubin <= 1.5 times the upper limit of normal value or direct bilirubin <= 1.0 times the upper limit of normal value AST and ALT <= 2.5 times the upper limit of normal value, and liver metastasis must be <= 5 times the upper limit of normal value 9) Ability to comply with the plan; 10) The toxic side effects of any previous chemotherapy have returned to <= CTCAE level 1 or baseline, with the exception of symptomatic stable sensory neuropathy or hair loss <= CTCAE level 2.
Exclusion criteria
Exclusion criteria: 1. People who are known to be allergic to the active or inactive ingredients of nilaparil or drugs with similar chemical structure; 2. Major surgery was performed within 3 weeks before the start of the study, or complications/sequelae were not recovered; 3. Aggressive cancers other than ovarian cancer (except fully treated basal or squamous cell skin cancer) within 5 years prior to enrollment; 4. Patients with previously or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 5. Having a serious or uncontrollable disease; 6. History of bleeding tendency and thrombus; 7. A history of severe cardiovascular disease; 8. Other laboratory tests were abnormal; 9. Prior treatment with any PARP inhibitor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS6; | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between HRD score and therapeutic effect of nilapali;Progression free survival; | — |
Countries
China
Contacts
Public ContactWin Wu
Obstetrics&Gynecology Hospital of Fudan University
Outcome results
None listed