ovarian cancer
Conditions
Interventions
Experimental group:fluzoparib combined with apatinib mesylate
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily joined the study and signed an informed consent form; 2. Female patients aged 18 to 70 years; 3. High-grade serous or endometrioid ovarian cancer, fallopian tube cancer or primary peritoneal cancer diagnosed by histopathology or cytology, and ovarian endometrioid cancer of grade >=2 diagnosed by pathology ; 4. After >=2 times of platinum-containing regimen treatment in the past, during the last platinum-containing regimen treatment period (from the beginning of the treatment to within 1 month after the last medication), the curative effect was non-PD, and the recurrence/progression within 6 months after the end of treatment (platinum Resistance); 5. ECOG score: 0-1; 6. There is at least one evaluable lesion, which is defined as one of the following: (1) At least one measurable lesion that meets the RECIST 1.1 standard (according to the requirements of RECIST v1.1, the long diameter of the spiral CT scan of the measurable lesion is >=10 mm or the short diameter of enlarged lymph nodes is >=15 mm; those who have received radiotherapy or local treatment in the past) The lesions can be used as target lesions after clarification of progress according to RECIST v1.1); (2)Evaluable disease: For patients with lesions or ascites and/or pleural effusion that do not meet the X-ray imaging examination defined by RECIST 1.1 for solid and/or cystic abnormalities, and have been pathologically proven to be related to disease and cancer antigens 125 (CA125) is twice the lowest point after treatment and is also greater than twice the upper limit of normal (ULN). 7. Expected survival period >= 12 weeks; 8. Able to swallow pills normally; 9. The function of vital organs meets the following requirements (it is not allowed to use any blood components, cell growth factor corrective treatment drugs within 14 days before enrollment): The absolute count of neutrophils>=1.5x10^9/L; Platelet >=90x10^9/L; Hemoglobin >=90 g/L; Serum albumin >=30 g/L; Bilirubin<=1.5xULN; ALT and AST <=3xULN; if there is liver metastasis, ALT and AST<5xULN. 10.Non-surgical sterilization or female patients of childbearing age need to use a medically approved contraceptive method after signing informed consent, during the study treatment period, and within 8 weeks after the end of the study treatment period; female patients of childbearing age who are non-surgically sterilized are enrolled in the study The blood HCG test within the first 72 hours must be negative; and it must be a non-lactating period.
Exclusion criteria
Exclusion criteria: 1. Past (within 5 years) or concurrently suffering from other uncured malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ and breast carcinoma in situ; 2. Subjects have received PARPi treatment in the past, including but not limited to olaparib, niraparib, rucapari and fluzoparib; Patients who have previously received PARPi for first-line maintenance treatment and recurrent EOC maintenance treatment can be included. 3. The subject has untreated central nervous system metastases, and has previously received systemic, radical brain or meningeal metastasis treatment (radiotherapy or surgery), if imaging confirmed that the stability has been maintained for at least 1 month, and the whole body has been stopped Patients with sex hormone therapy (dose>10 mg/day prednisone or other curative hormones) for more than 2 weeks without clinical symptoms can be included; 4. Patients with clinical symptoms of cancerous ascites and pleural effusion who need puncture or drainage or those who have received treatment for the purpose of drainage within 2 months before enrollment; 5. Past gastrointestinal perforation, abdominal abscess, or recent (within 3 months before enrollment) intestinal obstruction or imaging, clinical symptoms suggest intestinal obstruction; 6. Suffer from high blood pressure and cannot be well controlled by antihypertensive drugs (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); 7. There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) New York Heart Association (NYHA) heart failure above grade 2 ; (2) Unstable angina ; (3) Myocardial infarction occurred within 1 year ; (4) Room Fibrillation; clinically significant supraventricular or ventricular arrhythmia requires treatment or intervention ; (5) PR interval> 250 ms or QTc> 470 ms. 8. Abnormal blood coagulation function (INR> 2.0 or prothrombin time (PT)> 16 s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy (allowing the preventive use of low-dose aspirin, low molecular weight heparin); 9. There were clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis, etc. If stool occult blood is positive at baseline, review can be performed , If it is still positive after re-examination, combined with clinical judgment, perform gastroscopy if necessary; 10. Arterial/venous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc., superficial vein thrombosis Those who are judged can be included in the group; 11. Known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia patients, blood coagulation dysfunction, thrombocytopenia, etc.); 12. Accompanied by active ulcers, unhealed wounds or fractures; 13. Urine routine test showed urine protein >= ++ and confirmed 24-hour urine protein content> 1.0 g; 14. The patient has active infection, fever of unknown origin within 7 days before enrollment, >=38.5 degree, or baseline white blood cell count >15x10^9/L; 15. Patients with congenital or acquired immune deficiencies (such as HIV-infected persons); 16. For patients with bone metastases, the palliative radiotherapy area >5% o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Duration of remission;Progression-free survival;No-progression treatment interval;Total lifetime;Adverse event; | — |
Countries
China
Contacts
Public ContactChen Hongmin
Henan Cancer Hospital
Outcome results
None listed