| Eligibility |
Inclusion Criteria:
- The patient voluntarily joined the study and signed the informed consent.
- Age 18-75 years old.
- Participant has histologically confirmed diagnosis of high-grade predominantly serous
ovarian cancer, fallopian tube cancer, primary peritoneal cancer; Or moderately or
poorly differentiated ovarian endometrioid adenocarcinoma.
- Previously, after undergoing 2-3 lines of platinum containing chemotherapy, CR or PR
was achieved, and the time from the penultimate platinum containing chemotherapy to PD
was = 6 months.
- Patients who have received previous treatment with bevacizumab are acceptable.
- Allow previous treatment with PARP inhibitors other than Fluzoparib.
- ECOG score: 0-1.
- Participant has adequate organ function as defined in the following contents (Any
blood component or cell growth factor within 14 days prior to randomization is not
permitted) Absolute neutrophil count (ANC) =1.5×109/L Platelets =100×109/L Hemoglobin
=10g/dL Serum albumin =3g/dL Total bilirubin =1.5 ×ULN AST (SGOT) and ALT (SGPT) =3 ×
ULN Serum creatinine =1.5 × ULN
- Patients with potential fertility need to use a medically approved contraceptive (such
as an intrauterine device, birth control pill or condom) during he study treatment
period and within 2 months after the last administration of apatinib or 6 months after
the last administration of fluzopril, whichever is longer; Serum HCG or urine HCG must
be negative within 72 hours prior to study enrollment; must be a non-lactation period.
Exclusion Criteria:
- Previous (within 5 years) or concurrent with other uncured malignant tumors, except
for cured skin basal cell carcinoma, thyroid cancer, cervical carcinoma in situ and
breast cancer with no recurrence >3 years after radical surgery.
- The subject has untreated central nervous system metastasis.
- Inability to swallow pills normally, or gastrointestinal dysfunction, which may affect
drug absorption according to the researchers.
- Recent (within 3 months) occurrence of intestinal obstruction.
- Patients with clinical symptoms of cancerous ascites and pleural effusion, who need
puncture or drainage, or who have received ascites and pleural effusion drainage
within 2 months before the first trial medication.
- Patients with poorly controlled cardiac clinical symptoms or diseases, such as: (1)
NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction
within 1 year, (4) clinically significant supraventricular or ventricular arrhythmia
requiring treatment or intervention, (5) QTc>470ms.
- Those with abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4
seconds), who have a bleeding tendency or are receiving thrombolytic or anticoagulant
therapy, are allowed to receive low-dose low-molecular weight heparin or oral aspirin
prophylactic anticoagulant therapy during the trial.
- The subject has an active infection or unexplained fever >38.5 degrees during the
screening period and before the first dose;
- Subjects with congenital or acquired immune deficiency (such as HIV infection), or
active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA=500 IU/ml;
Hepatitis C reference: HCV antibody positive and HCV copy number > upper limit of
normal).
- Those who had previously received radiotherapy, chemotherapy, endocrine therapy, or
molecular targeted therapy and were enrolled less than 4 weeks after the completion of
treatment (last dose); Adverse events (except alopecia) caused by previous treatment
did not recover to =1 degree (CTCAE 5.0).
- Patients who have used other drugs in clinical trial studies within the previous 4
weeks.
- Subjects may receive other systemic anti-tumor therapies during the study period.
- known allergy to Fluzoparib, apatinib and its excipients.
- In the investigator's judgment, the subjects have other factors that may lead to the
forced termination of the study, such as other serious medical conditions (including
mental illness) requiring combined treatment, serious laboratory abnormalities, family
or social factors that may affect the safety of the subjects, or the collection of
data and samples.
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