Ovarian cancer
Conditions
Interventions
Observation group:None
Sponsors
Hefei Cancer Hospital, Chinese Academy of Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18 - 75 years old, regardless of gender. 2.Histologically or cytologically diagnosed as primary high - grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. 3.The last chemotherapy was a platinum - containing regimen, achieving complete remission (CR) or partial remission (PR). 4.According to the RECIST 1.1 criteria, there are measurable lesions at baseline. 5.Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0 - 1. 6.No prior use of PARP inhibitors. 7.Good function of major organs, meeting the following criteria: a) Blood routine examination (without blood transfusion and without the use of hematopoietic stimulating factor drugs to correct the condition within 14 days): Hemoglobin (Hb) >= 90 g/L; Absolute neutrophil count (ANC) >= 1.5×10?/L; Platelets (PLT) >= 90×10?/L. b) Biochemical examination: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 60 mL/min. c) Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) = 2 +, 24 - hour urine protein quantification should be =50%. 8.Women of child - bearing age should agree to use contraceptive measures (such as intra - uterine devices, contraceptives, or condoms) during the study and within 6 months after the end of the study; have a negative serum or urine pregnancy test within 7 days before study enrollment, and must be non - lactating patients. Men should agree to use contraceptive measures during the study and within 6 months after the end of the study. 9.Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow - up.
Exclusion criteria
Exclusion criteria: 1.Patients who are simultaneously participating in other clinical trials. 2.Patients with a history (within 5 years) or concurrent presence of other untreated malignant tumors, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and breast cancer with no recurrence > 3 years after radical surgery. 3.Patients with no measurable lesions or non - assessable lesions. 4.Known brain metastases or leptomeningeal metastases; patients suspected of central nervous system metastases need to undergo cranial examinations for confirmation. 5.Currently having uncontrollable malignant pleural effusion, ascites, or pericardial effusion (defined as unable to be effectively controlled by diuretics or puncture as judged by the investigator). 6.Subjects with evidence or a history of thrombosis or obvious bleeding tendency within 2 months before the first administration of the study drug (bleeding > 30 mL within 2 months, presenting with hematemesis, melena, hematochezia), hemoptysis (> 5 mL of fresh blood within 4 weeks). 7.Having uncontrolled comorbidities, including but not limited to: active HBV or HCV infection; known HIV infection or a history of AIDS; active syphilis; active tuberculosis; active infection; uncontrolled hypertension, symptomatic cardiac insufficiency; active bleeding. 8.Having hypertension that cannot be well - controlled with antihypertensive drugs (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg). 9.Having taken drugs that clearly affect the study drug within 30 days or 5 half - lives (whichever is longer) before enrollment. 10.Pregnant or lactating women. 11.Having a clear history of mental disorders (including epilepsy or dementia); or other conditions that the investigator deems inappropriate for participation in the study. 12.Unable to swallow tablets normally, or having abnormal gastrointestinal function, which may affect drug absorption as judged by the investigator. 13.Patients who, as judged by the investigator, are unlikely to comply with the study procedures, restrictions, and requirements shall not participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Time to next progression; | — |
Countries
China
Contacts
Public ContactXiaotao Qian
Hefei Cancer Hospital, Chinese Academy of Sciences
Outcome results
None listed