| Eligibility |
Inclusion Criteria:
1. Age 18-75 years; 2. Pathohistological or cytology confirmed as ovarian transparent cell
carcinoma, and FIGO stage in 2018 is stage III-IV; = four courses of chemotherapy and
failed to reach CR 3. ECOG score; 0-2 points; 4. Expected survival = 3 months; 5. The
investigator confirmed to have at least one measurable lesion (10 mm long diameter of CT
scan of tumor lesions =10 mm, short diameter of CT scan of lymph node lesions =15 mm))
according to the RECIST 1.1 standard), or ascites 6. The main organs function normally, and
the test results during screening must meet the following requirements:
1. Blood routine examination criteria should be met (no blood transfusion and blood
products within 14 days, no use of G-CSF and other hematopoietic stimulating factors
to correct):
A. Hemoglobin (Hb) = 80 g/L; B. Number of neutrophils (ANC) = 1.5 × 109/L; C. Platelet
count (PLT) = 80 ×109/L;
2. Biochemical inspection must meet the following standards:
A. Total bilirubin (TBIL) < 1.5 Upper limit of normal value (ULN); B. Alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 ULL compared <with 5 ULN
for patients with liver metastases; C. serum creatinine (Cr) = 1.5 ULN or endogenous
creatinine clearance > 60 ml/min (Cockcroft-Galt formula); D. Urine routine test results
show urine protein (UPRO) < 2+ or 24-hour urine protein quantitative <1 g; 7. Women of
gestational age must agree to adequate contraception for the entire duration of the study
and within 6 months after the end of treatment.
8.Signed a written informed consent form with good expected adherence to the research
protocol.
Exclusion Criteria:
1. Have previously received anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies
(or any other antibodies acting on the T cell synergistic stimulation or checkpoint
pathway);
2. Previous exposure to other anti-angiogenic small molecule TKI drugs, such as apatinib,
alotinib, sorafinil, regofinib, etc.;
3. Patients with active brain metastases (for patients with stable symptoms after
treatment of brain metastases, they can be selected if they remain in a stable state
for at least 4 weeks);
4. Immunosuppressive drugs have been used within 28 days before the first use of
carirelizumab, excluding nasal and inhaled corticosteroids or systemic steroid
hormones in physiological doses (i.e., prednisolone or other corticosteroids of
equivalent pharmacophysiological doses not exceeding 10 mg / day);
5. Received systematic systemic therapy with anti-tumor indications of Chinese herbal
medicine or immunomodulatory effect (including thymus peptide, interferon,
interleukin, except for the control of pleural effusion topical use) within 2 weeks
before the first administration;
6. Suffering from serious cardiovascular diseases: myocardial ischemia or myocardial
infarction above grade II, poorly controlled arrhythmias (including QTc interval men =
450 ms, women = 470 ms); Grade III. to IV. cardiac insufficiency (see Annex 3
according to the NYHA grade of the New York Cardiology Society), or if the left
ventricular ejection fraction (LVEF) < 50% on cardiac color ultrasound;
7. Complicated by severe infection within 4 weeks before the first medication (eg,
intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained
fever > during screening / before the first administration 38.5°C; or major surgical
treatment within 3 weeks prior to the first medication;
8. The presence of active autoimmune diseases or immunodeficiency, or the history of the
above, including but not limited to: autoimmune hepatitis, interstitial pneumonia,
uveitis, rheumatoid arthritis, inflammatory bowel disease, pituititis, vasculitis,
nephritis, etc.) shall not be included. The following exceptions are those with a
history of autoimmune hypothyroidism but receiving thyroid hormone replacement
therapy. After treatment with an insulin dosing regimen, patients with type 1 diabetes
whose blood glucose is controlled may participate in this study.
9. Subjects undergo systematic treatment such as bronchodilators, asthma control is not
satisfactory, can not be included (asthma in childhood has been completely resolved,
adults do not need any intervention can be included).
10. Human immunodeficiency virus (HIV) infection or known to have acquired
immunodeficiency syndrome (AIDS), untreated active hepatitis B, hepatitis C (hepatitis
C antibody positive, and HCV-RNA is higher than the lower limit of detection of
analytical methods) or co-infection with hepatitis B and C;
11. The subject has received or plans to receive a transplant of a solid organ or blood
system during the study (except for corneal transplantation);
12. Are currently participating in interventional clinical research or has been treated
with other experimental drugs or research devices within 4 weeks prior to the first
dose; Adequate recovery from toxicity and/or complications caused by any intervention
before the first dose (i.e., ? grade 1 or at baseline, excluding fatigue or hair
loss);
13. Have a clear history of allergies, may be potentially allergic or intolerant to the
test drug and its similar biological agents;
14. Those with a history of psychotropic drug abuse and who cannot be withdrawn or have
mental disorders;
15. People with a history of hereditary or acquired bleeding or coagulation dysfunction
(it is up to the investigator to determine whether they can be selected)
16. Uncontrolled hypertension (systolic blood pressure = 140 mmHg or diastolic blood
pressure =90 mmHg, despite optimal drug therapy);
17. Those who have had significant coughing up blood 2 months prior to entry into the
study, or who have had a daily hemoptysis volume of half a teaspoon (2.5 ml) or more;
or have had clinically significant bleeding symptoms or a clear tendency to bleed
within 3 months prior to the study, such as gastrointestinal bleeding, hemorrhagic
gastric ulcer, or vasculitis; or arteriovenous thrombosis events that occurred within
6 months prior to the study, such as cerebrovascular accidents (including temporary
ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and
pulmonary embolism;
18. Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT
>1.5ULN), with bleeding tendencies or being undergoing thrombolytic or anticoagulant
therapy;
19. Urine routine suggests that urine protein =++, or confirm that the amount of urine
protein = 1.0g in 24 hours;
20. Increases the risk associated with participating in a study or trial drug and,
according to the investigator's judgment, can lead to other circumstances in which the
patient is unsuitable for the study to be selected.
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