Ovarian cancer
Conditions
Interventions
Sponsors
Anqing Municipal Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-70 years; 2. ECoG PS: 0-1; 3. Patients with advanced ovarian cancer confirmed by histopathology or cytology; 4. Patients who have failed to receive at least one chemotherapy regimen (combined with or without targeted therapy) in the past, and need to be confirmed by imaging, are progressing during or after treatment; 5. Patients with at least one measurable lesion (RECIST 1.1); 6. Patients whose baseline blood routine and biochemical indexes meet the following criteria: (1) Hemoglobin >= 90g / L (2) Absolute neutrophil count (ANC) >= 1.5 x 10^9 / L (3) Platelets >= 80 x 10^9 / L (4) Alt, AST = 45 ml / min (Cockcroft Gault formula); 7. Subjects without blood transfusion or blood products within 14 days were not corrected with G-CSF or other hematopoietic stimulating factors; 8. Patients whose expected survival time is more than or equal to 3 months; 9. Subjects with sufficient organ function; 10. Women of childbearing age must conduct pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they are willing to use appropriate contraceptive methods during the test period and 8 weeks after the last administration of the test drug. 11. The subjects voluntarily joined the study, signed informed consent, good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Subjects who have proved to be allergic to the study drug and / or its excipients; 2. The subjects are using immunosuppressant, systemic or absorbable local hormone therapy to achieve the purpose of immunosuppression (dose > 10mg / day prednisone or other therapeutic hormones), and have received clinical trial drug treatment or used clinical research medical devices in the first 4 weeks of continued use within 2 weeks before enrollment. 3. Subjects with hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg) who could not be reduced to the normal range after antihypertensive drug treatment had grade I or above coronary heart disease and grade I arrhythmia (including QTc interval prolongation, male > 450 ms, female > 470 MS); 4. According to NYHA standard, subjects with grade III-IV cardiac insufficiency or left ventricular ejection fraction (LVEF) 1.5, APTT > 1.5 ULN), with bleeding tendency; existing hereditary or acquired bleeding and thrombosis tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.); 6. Subjects with wounds or fractures that have not been cured for a long time; subjects who have undergone major surgery or severe traumatic injury, fracture or ulcer within 4 weeks; 7. Patients with abdominal fistula, gastrointestinal perforation or abdominal abscess; patients with acute or chronic active hepatitis B or hepatitis C infection, hepatitis B virus (HBV) DNA > 2000 IU / ml; hepatitis C virus (HCV) RNA > 500 IU / ml; HBsAg and anti HCV antibody were positive at the same time. After nucleotide antiviral therapy, the patients who were lower than the above criteria could be enrolled. 8. Patients with active brain metastasis, carcinomatous meningitis, spinal cord compression, or diseases of brain or pia mater found by CT or MRI during screening (patients with brain metastasis who had completed treatment 21 days before medication and had stable symptoms can be enrolled, but they need to be confirmed as having no symptoms of cerebral hemorrhage by MRI, CT or venography evaluation); 9. Imaging (CT or MRI) showed that the distance between the tumor focus and the great vessels was less than or equal to 5 mm, or the lesion invaded the local great vessels; 10. Pregnant or lactating women; 11. Those who have a history of psychotropic drug abuse and can not give up or have mental disorders; 12. According to the judgment of the researcher, there are patients with accompanying diseases that seriously endanger the safety of patients or affect the completion of the study; 13. Subjects considered unsuitable by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS;DCR;AE; | — |
Countries
China
Contacts
Public ContactQian Jiang
Anqing Municipal Hospital
Outcome results
None listed