| Eligibility |
Inclusion Criteria:
1. Subjects must be female =18 years old;
2. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1;
3. Postoperative administration time: within 12 weeks after the maximum tumor reduction
operation;
4. Histologically or pathologically confirmed advanced (FIGO stage III - IV) ovarian
cancer, fallopian tube cancer, or primary peritoneal cancer;
5. Subjects have enough organ function: (1) Blood routine(without blood transfusion or
hematopoietic stimulating factor within 7 days before screening ): a.Hemoglobin
(HB)=9.0g/L; b.Absolute value of neutrophil (ANC)=1.5 * 10^9 / L; c.Platelet (PLT)=80
* 10^9 / L; (2) Liver and Renal function(without blood or albumin transfusion within 7
days before screening ): a. Alanine aminotransferase (ALT) and AST=2.5 times the upper
limit of normal value and ALT (AST=5 times the upper limit of normal value when
liver/bone metastasis) b. total bilirubin =1.5 times the upper limit of normal value;
c.serum creatinine =1.5 times the upper limit of normal value, creatinine clearance=60
ml/min; (3)Blood coagulation function: a.Activated partial thromboplastin time,
international standardized ratio adn prothrombin time =1.5 times the upper limit of
normal value; b.Doppler echocardiographic evaluation: left ventricular ejection
fraction(LVEF)= 50%
6. Subjects agreed to join the study and signed informed consent;
Exclusion Criteria:
1. Previously received anti angiogenic drugs including but not limited to small molecules
such as anotinib and apatinib and large molecules such as bevacizumab.
2. Patients allergic to the any test drug.
3. Combined disease/ history:
1. Clinical significant hemoptysis occurred within 3 months before admission (daily
hemoptysis was greater than 50ml), or significant clinical bleeding symptoms or
definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric
ulcer, baseline fecal occult blood or above, or suffering from vasculitis, etc;
2. Arteriovenous thrombosis events occurred within 6 months before grouping, such as
cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis
(except venous thrombosis caused by venous catheterization due to early chemotherapy)
and pulmonary embolism;
3. Hypertension, which can not be well controlled by antihypertensive drugs (systolic
blood pressure>140 mmHg or diastolic blood pressure>90 mmHg); Myocardial infarction,
severe / unstable angina pectoris, cardiac insufficiency above New York Heart
Association(NYHA) , supraventricular or ventricular arrhythmias with clinical
significance, and symptomatic congestive heart failure occurred within 6 months before
grouping;
4. Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic
diseases (e.g. diabetes, pulmonary fibrosis and acute pneumonia);
5. Renal insufficiency: urine routine indicates urinary protein = + +, or confirms
24-hour urinary protein = 1.0g;
6. History of live attenuated vaccine vaccination within 28 days before the first study
medication or expected live attenuated vaccination during the study period;
7. Human immunodeficiency virus infection or known acquired immunodeficiency syndrome
(AIDS); active hepatitis;
8. There were severe infections within 4 weeks before the first administration,
including, but not limited to, bacteremia and severe pneumonia requiring
hospitalization; active infections requiring systemic antibiotics treatment of grade
CTCAE = 2 within 2 weeks before the first administration, or unexplained fever > 38.5
°C during the screening period / before the first administration (the researchers
judged that fever caused by tumors could be included in the group); there was evidence
of active tuberculosis infection within 1 year before administration;
9. Any other malignant tumor has been diagnosed within 3 years before enrollment, except
for fully treated basal cell carcinoma or squamous cell skin cancer or cervical
carcinoma in situ;
10. Major surgery was performed within 28 days before enrollment (tissue biopsy required
for diagnosis and central venous catheterization via peripheral venipuncture are
allowed);
11. Subjects who have previously received or are prepared to receive allogeneic bone
marrow transplantation or solid organ transplantation;
12. Patients with peripheral neuropathy =2 grade 2; patients with active brain metastasis,
carcinomatous meningitis, spinal cord compression, or diseases found in brain or
leptomeninges by imaging CT or MRI examination during screening (patients with brain
metastasis who had completed treatment 14 days before admission and whose symptoms
were stable can be enrolled in the group, but no symptoms of cerebral hemorrhage
should be confirmed by cranial MRI, CT or venography);
13. Factors that significantly affect the absorption of oral drugs, such as inability to
swallow, chronic diarrhea, and intestinal obstruction with significant clinical
significance
4. Women of child-bearing potential should have negative results of serum or urine
pregnancy test. Women must use adequate birth control in the duration of study
participation.
5. Other serious physical or mental disorders or laboratory abnormalities that may increase
the risk when in this study or interfere with the results of the study, and patients whom
the researchers believe are not suitable for this study.
|
