| Eligibility |
Inclusion Criteria:
1. Female patients aged between 18 and 75 years old;
2. Patients received open surgery, laparoscopic surgery, or coarse needle aspiration
biopsy and confirmed as high-grade serous or endometrioid ovarian cancer, peritoneal
cancer, or fallopian tube cancer (hereinafter referred to as ovarian cancer). FIGO
stage III-IV;
3. BRCA1/2 gene mutation or HRD gene mutation is confirmed by testing tissue or blood
samples;
4. According to RECIST 1.1 standard, the patient has at least one target lesion with
measurable diameter (the long diameter of CT scan for tumor lesions is = 10mm, the
short diameter of CT scan for lymph node lesions is = 15mm, and the scanning thickness
is 5mm);
5. Judge the patients who cannot achieve R0 tumor reduction or cannot tolerate surgery.
The criteria for failing to achieve R0 tumor reduction include but are not limited to:
(1) Fagotti score = 8; (2) When the laparoscopic evaluation method is difficult to
implement, the upper abdomen CT score is = 3 (SUDANCT score);
The criteria for surgical intolerance are as follows:
(3) Body mass index: BMI = 40.0; (4) Various chronic diseases; (5) Malnutrition or
hypoproteinemia; (6) Moderate to massive ascites; 6. ECOG PS 0-1 point; 7. The main organs
function normally and meet the following standards:
1. The blood routine examination standard shall meet: (no blood transfusion within 14
days)
1. HB=100g/L,
2. WBC=3 × 109/L
3. ANC=1.5 × 109/L,
4. PLT=100 × 109/L;
2. Biochemical examination shall meet the following standards:
1. BIL = 1.5 times the upper limit of normal value (ULN);
2. ALT and AST = 2.5 × ULN, ALT and AST = 5 in patients with liver metastasis × ULN;
3. Serum Cr = 1.5 × ULN? 8. International normalized ratio (INR) OR prothrombin time
(PT), activated partial thrombin activity time (aPTT) = 1.5 × ULN, unless the
patient is receiving anticoagulant treatment, as long as PT or aPTT is within the
expected treatment range of anticoagulant drugs; 9. There is no obstacle of
strict center of gravity, lung, liver and kidney; 10. Women of childbearing age
must have a pregnancy test (serum) within 7 days before enrollment, and the
result is negative, and are willing to use appropriate methods of contraception
during the test period and 8 weeks after the last administration of the test
drug; 11. Estimated total survival time = 6 months, postoperative survival time =
3 months; 12. Sign the written informed consent, and be able to comply with the
visit and relevant procedures specified in the scheme.
Exclusion Criteria:
1. Other clinical drug experiments in which other experimental research drugs are used
together with the study;
2. In addition to this study, use other cancer neoadjuvant therapies, including but not
limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, microbial
therapy, traditional Chinese medicine therapy and other experimental treatments;
3. Patients known to be allergic to fluzoparide or allergic to active or non active
components of fluzoparide with similar chemical structure;
4. Patients known to be allergic to appatinib or allergic to active or inactive
components of drugs with similar chemical structure to appatinib;
5. It is impossible to swallow the oral drug and any gastrointestinal disease that may
interfere with the absorption and metabolism of the study drug, such as uncontrollable
nausea and vomiting, gastrointestinal obstruction or malabsorption;
6. Have used known or possible PARP inhibitors and anti vascular production inhibitors in
the past;
7. Symptomatic or uncontrolled brain metastasis requiring simultaneous treatment,
including but not limited to surgery, radiotherapy and/or corticosteroids, or clinical
manifestations of spinal cord compression;
8. Subjects suffered from other malignant diseases in the past 3 years, except skin
squamous cell carcinoma, basal like carcinoma, breast intraductal carcinoma in situ or
cervical carcinoma in situ;
9. The patient was previously or currently diagnosed as myelodysplastic syndrome (MDS) or
acute myeloid leukemia (AML);
10. Recently (within 3 months), there has been intestinal obstruction and gastrointestinal
perforation;
11. There are clinical cardiac symptoms or diseases that are not well controlled, such as:
(1) NYHA level 2 or above cardiac insufficiency (2) unstable angina pectoris (3) acute
myocardial infarction within one year (4) clinically significant supraventricular or
ventricular arrhythmia requiring treatment or intervention (5) QTc>470ms;
12. Any bleeding event with a severe grade of 2 or above in CTCAE 5.0 occurred within 4
weeks before the first trial medication;
13. People with hypertension who can not be well controlled after antihypertensive drug
treatment (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg);
14. Idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation
pneumonia, organized pneumonia, drug pneumonia, or active pneumonia shown on CT during
screening period have been or are currently present;
15. Those with abnormal coagulation function (INR > 1.5 or prothrombin time (PT) >
ULN+4s), who have bleeding tendency or are receiving thrombolytic or anticoagulant
treatment (including but not limited to patients requiring long-term anticoagulant
treatment), are allowed to receive low dose low molecular weight heparin or oral
aspirin preventive anticoagulant treatment during the trial;
16. Diagnose patients with deep vein thrombosis (except intermuscular vein thrombosis);
17. People with a history of hereditary or acquired haemorrhagic disease or blood
coagulation dysfunction. There were bleeding symptoms with significant clinical
significance or clear bleeding tendency within 3 months before the first trial drug
use, such as gastrointestinal bleeding, bleeding gastric ulcer, etc;
18. The subject has congenital or acquired immune deficiency (such as HIV infected
persons), or active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA = 500
IU/ml; hepatitis C reference: HCV antibody positive and HCV copy number>the upper
limit of normal value);
19. The patient received platelet or red blood cell infusion within four weeks before the
start of the study drug treatment;
20. Patients who are pregnant or nursing, or who plan to become pregnant during the study
treatment.
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