| Eligibility |
Inclusion Criteria:
- 1. Age: 18 =75 years old, female; 2. Pathological (including histological) evidence of
ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer (ovarian
cancer); 3. Received first-line platinum drug chemotherapy in the past, the curative
effect during the last treatment with platinum regimen (from the start of treatment to
within 1 month after the last administration) was non-PD, and the
recurrence/progression (platinum resistance) within 6 months after the end of
treatment; Or recurrence or progression (platinum-sensitive) =6 months after the end
of the last platinum-containing treatment; CR/PR/SD after at least 4 cycles of
chemotherapy again; 4. According to RECIST1.1 criteria, the patient had at least one
target lesion with measurable diameter (tumor lesion with CT scan length =10mm, lymph
node lesion with CT scan short diameter =15mm, and scanning layer thickness 5mm); 5.
ECOG PS 0-1 score; 6. Major organs function normally and meet the following criteria:
1. The standard of blood routine examination must 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 upper limit of normal value (ULN);
2. ALT and AST=2.5×ULN, and ALT and AST=5×ULN in patients with liver
metastasis;
3. Serum Cr=1.5×ULN. 7. International Standardized ratio (INR) OR prothrombin
time (PT), activated partial thrombin activity time (aPTT)=1.5 × ULN, unless
the patient is receiving anticoagulant therapy, as long as PT or aPTT is
within the therapeutic range of the anticoagulant drug intended to be used;
8. No serious heart, lung, liver, kidney disorders; 9. Women of reproductive
age must undergo a pregnancy test (serological) within 7 days prior to
enrollment, with a negative result, and be willing to use an appropriate
method of contraception during the trial period and 8 weeks after the last
dose of the test drug; 10. The expected overall survival =6 months,
post-treatment survival =3 months; 11. Sign a written informed consent and
be able to comply with the visit and related procedures specified in the
program.
Exclusion Criteria:
1. Other clinical drug experiments in which other experimental drugs are used at the same
time as the study;
2. Other cancer treatments, including but not limited to chemotherapy, radiotherapy,
targeted therapy, immunotherapy, microbiological therapy, traditional Chinese medicine
therapy and other experimental therapies, were used in conjunction with this study;
3. Patients who are known to be allergic to fluzoparil or to active or inactive
components of the drug with a similar chemical structure;
4. Patients who are known to be allergic to Apatinib or to active or inactive components
of the drug with a similar chemical structure;
5. Inability to swallow oral medications and any gastrointestinal disorders that may
interfere with study drug absorption and metabolism, such as uncontrolled nausea and
vomiting, gastrointestinal obstruction, or malabsorption;
6. Symptomatic or uncontrolled brain metastases requiring concurrent treatment, including
but not limited to surgery, radiation and/or corticosteroids, or clinical
manifestations of spinal cord compression;
7. The subject has had other malignant diseases in the past 3 years, except cutaneous
squamous cell carcinoma, basal-like carcinoma, ductal carcinoma in situ of the breast,
or carcinoma in situ of the cervix;
8. The patient has a prior or current diagnosis of myelodysplastic syndrome (MDS) or
acute myeloid leukemia (AML);
9. Recent (within 3 months) occurrence of intestinal obstruction, gastrointestinal
perforation;
10. Patients with clinical symptoms or diseases that are not well controlled, such as: (1)
NYHA2 or above cardiac dysfunction, (2) unstable angina pectoris, (3) acute myocardial
infarction occurred within 1 year, (4) clinically significant supraventricular or
ventricular arrhythmia requiring treatment or intervention, (5) QTc>470ms;
11. Any bleeding event with a severe CTCAE 5.0 rating of 2 or more occurring within 4
weeks prior to the initial trial administration;
12. People with hypertension who are not well controlled by antihypertensive medication
(systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg);
13. Previous or current idiopathic pulmonary fibrosis, interstitial pneumonia,
pneumoconiosis, radiation pneumonia, institutionalized pneumonia, drug-induced
pneumonia, or active pneumonia shown by CT during screening;
14. Patients with abnormal coagulation function (INR > 1.5 or prothrombin time (PT) >
ULN+4 seconds) who have bleeding tendencies or are receiving thrombolytic or
anticoagulant therapy (including but not limited to patients requiring long-term
anticoagulant therapy) are allowed to receive low-dose low-molecular weight heparin or
oral aspirin prophylactic anticoagulant therapy during the trial;
15. Diagnosis of patients with deep vein thrombosis (except intermuscular vein
thrombosis);
16. Patients with a history of hereditary or acquired bleeding or coagulation disorders.
There were clinically significant bleeding symptoms or definite bleeding tendencies
within 3 months before the first trial, such as gastrointestinal bleeding and
hemorrhagic gastric ulcer;
17. 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);
18. The patient received platelet or red blood cell transfusions within four weeks prior
to initiation of treatment with the investigational drug;
19. Patients who are pregnant or nursing, or who plan to become pregnant during the study
treatment period.
20. According to the researchers' judgment, the subjects have other factors that may lead
to the forced termination of the study.
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