ovarian cancer
Conditions
Interventions
Sponsors
Sir Run Run Shaw Hospital Zhejiang University,School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with ovarian cancer diagnosed by cytology or histopathology may be accompanied by ascites, disease progression during treatment or relapse after treatment, and patients with advanced ovarian cancer who have no standard treatment regimen above the second line; 2. Aged 18-70 years old female; 3. There are objectively measurable lesions according to the RECIST 1.0 standard; 4. ECOG score 0-2 points; 5. Expected to survive for more than 3 months; 6. White blood cells = 3.0×10^9, absolute neutrophil count = 1.5×10^9, platelets = 70×10^9, hemoglobin = 80g/L, ALT and AST are less than 2 times the upper limit of normal, total bilirubin is less than or equal to the upper limit of normal, serum creatinine is less than the upper limit of normal.
Exclusion criteria
Exclusion criteria: 1. Exceeding or currently suffering from other malignant tumors within 5 years, except for cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (in situ carcinoma) And T1 (tumor infiltrating basement membrane)]; 2. Plan for systemic anti-tumor therapy within 4 weeks prior to grouping or during the study, including cytotoxic therapy, signal transduction inhibitors, anti-tumor Chinese medicine, immunotherapy (or use within 6 weeks prior to receiving the test drug) Over mitomycin C). 3. Extensive field radiotherapy (EF-RT) was performed within 4 weeks prior to grouping or limited field radiotherapy to be evaluated for tumor lesions within 2 weeks prior to grouping; 4. Hair loss due to unresolved toxicity above CTC AE Level 1 due to any prior treatment; 5. Have multiple factors affecting oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction); 6. With pleural effusion or ascites, causing respiratory syndrome (= CTC AE grade 2 dyspnea); 7. Patients with brain metastases with symptoms or symptoms controlled for less than 2 months; 8. Patients with any severe and/or uncontrolled disease, including: 1) patients with unsatisfactory blood pressure control (systolic blood pressure =150 mmHg, diastolic blood pressure =100 mmHg); 2) with grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTC = 480ms) and = grade 2 congestive heart failure (New York Heart Association (NYHA) classification); 3) active or uncontrolled serious infection (= CTC AE Level 2 infection); 4) cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy; 5) Renal failure requires hemodialysis or peritoneal dialysis; 6) a history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; 7) poor diabetes control (fasting blood glucose (FBG)>10mmol/L); 8) Urine routine indicates that urine protein = ++, and confirmed 24-hour urine protein quantitation > 1.0 g; 9) patients with seizures who require treatment; 9. Major surgical treatment, open biopsy or significant traumatic injury within 28 days prior to grouping; 10. Imaging shows that the tumor has invaded the important perivascular circumference or that the patient is likely to invade the important blood vessels during the follow-up study and cause fatal bleeding. 11. Patients with any signs of hemorrhage or history, regardless of severity; patients with any bleeding or bleeding episodes = CTCAE 3 within 4 weeks prior to grouping have unhealed wounds, ulcers or fractures; 12. Overcurrent/venous thrombosis occurred within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism; 13. Those who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder; 14. Participated in other clinical trials of anti-tumor drugs within four weeks; 15. According to the investigator's judgment, a person with a serious risk of harm to the patient's safety or affecting the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate(DCR);Progression-free survival(PFS);disease control rate(DCR); | — |
Contacts
Public ContactHongming Pan
Sir Run Run Shaw Hospital Zhejiang University,School of Medicine
Outcome results
None listed