Ovarian cancer
Conditions
Interventions
Platinum-sensitive advanced ovarian cancer that has progressed after previous PARP inhibitor therapy:Fluzoparib in combination with apatinib
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily join the study, sign informed consent, have good compliance, and cooperate with follow-up; 2. Female, age = 18 years (calculated on the date of signing informed consent); 3. Confirmed by pathology: 1) High-grade serous ovarian cancer (fallopian tube cancer or primary peritoneal cancer; Endometrioid carcinoma of the ovaries of grade II =; 2) high-grade serous ovarian cancer or moderate- and low-differentiated ovarian endometrioid adenocarcinoma; - Mixed tumors: high-grade serous type predominantly or grade = II endometrium-like components must be >50%. 4. The study subjects are two types of patients: 1) PARP inhibitors are only used in patients with advanced epithelial ovarian cancer who have progressed platinum response (complete response (CR)/partial response (PR)) after platinum-containing chemotherapy after progression after first-line maintenance therapy; or 2) PARP inhibitors are only used in patients with advanced epithelial ovarian cancer who have progressed platinum response after the first platinum-sensitive recurrence maintenance therapy (post-progression platinum-containing chemotherapy CR/PR); 5. At least one measurable lesion that meets RECIST 1.1 criteria; 6. Receiving platinum-containing chemotherapy after the first PARP inhibitor maintenance therapy progression (the chemotherapy cycle doctor decides based on personal experience), and the best effect is CR/PR; or no residual disease (e.g., no lesions assessed after tumor reduction surgery prior to chemotherapy) and stable CA-125 without upward trend; 7. The time from the end of the last chemotherapy to the time before enrollment is not more than 8 weeks and the function of the patient's bone marrow and other organs is restored; 8. ECOG score: 0~1; 9. Expected survival= 16 weeks; 10. The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors during screening): ? Absolute neutrophil count= 1.5×109/L; ? platelet = 100×109/L; ? Hemoglobin= 10g/dL; ? serum albumin= 30g/dL; ? Bilirubin = 1.5 times ULN; ?ALT and AST =3 times ULN; Serum creatinine = 1.5 times ULN or creatinine clearance = 60 mL/min (standard Cockcroft-Gault formula applied); 11. Normal blood pressure or drug control within normal range. potential fertility requires the use of at least one medically recognized method of contraception (e.g., IUDs or condoms) during study treatment and within 3 months of the end of the study treatment period; Serum hCG must be negative prior to enrollment; Must be non-lactating.
Exclusion criteria
Exclusion criteria: 1. Previous (within 5 years) or other uncured malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ and breast cancer that has not recurred for > 3 years after radical resection; 2. Previous multi-line use of PARP inhibitors, including but not limited to olaparib, pamiparib, nirapanib and rucapanib; or previous antivascular therapy (bevacizumab, apatinib, etc.); 3. Patients with untreated central nervous system metastases, previous systemic or radical brain or meningeal metastases (radiotherapy or surgery), if the imaging confirmation that stability has been maintained for at least 1 month, and systemic hormone therapy (dose> 10mg/day prednisone or other effective hormones) has been stopped for more than 2 weeks, and patients without clinical evidence can be included; 4. Those who cannot swallow drugs normally, or have abnormal gastrointestinal function, which may affect drug absorption as judged by researchers; 5. Those who have recently (within 3 months) had intestinal obstruction and gastrointestinal perforation; 6. Patients with clinical symptoms of ascites or pleural effusion, who need puncture or drainage, or who have received ascites or pleural effusion drainage within 3 months before the first test of medication; 7. There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) heart failure above NYHA level 2 (2) unstable angina (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) QTc> 470ms; 8. Patients with hypertension and unable to obtain good control after treatment with antihypertensive drugs (systolic blood pressure = 140mmHg or diastolic blood pressure =90mmHg); 9. Abnormal coagulation function (INR>1.5 or prothrombin time (PT) >ULN+4 seconds), with bleeding tendency or receiving thrombolysis or anticoagulation therapy; Reception of low-dose molecular heparin or oral aspirin prophylactic anticoagulation therapy during the experiment is allowed; 10. Significant clinically significant bleeding symptoms or clear bleeding tendencies within 3 months, such as gastrointestinal bleeding and hemorrhagic gastric ulcer; 11. Previous or current idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, tissue pneumonia (such as bronchitis, obliterative vasculitis), drug-induced pneumonia, or CT during screening with active pneumonia; 12. Subject has active infection or fever of unknown cause during screening and before the first dose> 38.5 degrees; 13. Subject congenital or acquired immunodeficiency (such as HIV-infected), or active hepatitis (hepatitis B reference: HBsAg positive, HBV DNA= 2000 IU/ml or copy number = 104/ml; Hepatitis C reference: positive for HCV antibodies, HCV virus copy number >upper limit of normal value); 14. Those who previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecularly targeted therapy, after the completion of treatment (last dose), less than 4 weeks before study enrollment; Those whose AE (excluding hair loss) caused by previous treatment has not recovered to =1 degrees (NCI-CTCAE V5. O); 15. Those who have used other drug clinical trial study drugs within 4 weeks before the first dose; 16. Subject may receive other systemic antineoplastic therapy during the study; 17. Patients with active bleeding, ulcers, intestinal perforation, intestinal obstruction, and major surgery w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;progression-free survival;16 week PFS rate;1-year OS rate; | — |
Countries
China
Contacts
Public ContactGuoYun Wang
Shandong Provincial Hospital
Outcome results
None listed