platinum-resistant or platinum-refractory ovarian cancer
Conditions
Interventions
Group 1:Apatinib combined with oral etoposide
Group 2:oral etoposide
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily joined the study, signed informed consent, good compliance, and follow-up; 2. Female aged 18-70 years; 3. ECOG PS0-2 4. Recurrent platinum-resistant ovarian cancer confirmed by histology or pathology; 5. At least received one first-line platinum-containing regimen 6. The interval of last time using platinum-containing regimen chemotherapy to the current interval <6 months or progression of disease during chemotherapy with platinum-containing regimen. 7. According to the RECIST version 1.1 standard (see appendix), there is at least one extracranial measurable lesion [screw CT scan =10 mm (CT scan layer thickness is not more than 5mm), which can measure the lesion without receiving radiotherapy or other topical treatment, unless progress after treatment is completed 8. The last treatment before enrollment has confirmed imaging progression 9. Estimated lifetime=3 months 10. The function of main organs is normal, the following criteria should be met: Blood routine: Hb=90 g/L(No blood transfusion within 14 days); ANC=1.5×10^9/L; PLT=75×10^9/L; Biochemical tests are subject to the following criteria: TBIL=1.5×ULN (Upper Limit Of Normal); ALT and AST=2.5×ULN; If there is liver metastasis ALT and AST=5×ULN; Serum creatinine=1.5×ULNCCR(Creatinine Clearance Rate)=50ml/min (Based on Cockroft and Gault formulas); 11. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating woman; 2. Those who have been confirmed to be allergic to apatinib, etoposide and/or their excipients; 3. People with high blood pressure who are unable to obtain good control by antihypertensive drugs (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), have suffered from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, Poorly controlled arrhythmias (including female QTc interval = 470 ms); according to NYHA criteria, grade III to IV cardiac insufficiency, or echocardiography revealed a left ventricular ejection fraction (LVEF) 1.0 g; 5. Patients with a variety of factors affecting the oral and absorption of drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 6. Patients with active brain metastases or pia mater disease; 7. Abnormal coagulation (INR > 1.5 or PT > ULN + 4 seconds or APTT > 1.5 ULN), is receiving thrombolytic or anticoagulant therapy, has bleeding tendency, or has clear gastrointestinal or other organ bleeding concerns (such as a local active ulcer lesion, fecal occult blood positive); 8. Overactive/venous thrombosis occurred within 6 months prior to the start of the study, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism; 9. Long-term unhealed wounds or fractures in the chest and other areas; 10. Serious or uncontrolled infection (NCI-CTCAE 4.03>level 2); 11. Patients with a history of psychotropic substance abuse who is unable to quit or has a history of mental disorders; 12. Previous use of anti-angiogenic drugs and etoposide treatment; 13. Have a history of other malignant tumors in the past 5 years, however, cured skin basal cell carcinoma and cervical carcinoma in situ will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DCR;DOR;safety; | — |
Countries
China
Contacts
Public ContactJin Wu
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed