Recurrent Ovarian Cancer
Conditions
Interventions
Group 1:Doxorubicin hydrochloride Dox 40 mg/m2 D1 (1 course every 28 days)
Group 2:Dox 40 mg/m2 D1 + Apatinib Dox 40 mg/m2 D1 + Apatinib
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. The previous pathology was diagnosed as high-grade ovarian serous carcinoma; 2. Platinum-resistant relapse, initial platinum-resistant relapse (PRP) recurred 6 months after first-line platinum chemotherapy; 3. Patients with malignant pleural effusion or clinically evaluable recurrence lesions undergoing reoperation can obtain specimens; 4. ECOG score 0 or 1 5. Expected survival >=4 months; 6. There are no targeted therapies in this relapsed treatment; 7. According to the solid tumor efficacy evaluation standard (RECIST1.1), at least one measurable lesion; 8. The function of vital organs meets the following requirements; Absolute neutrophil count>=1.5*10^9/L; Platelets 100*1069/L; Hemoglobin>=90g/dL; 9. The function of vital organs meets the following requirements; Total Bilirubin<=ULN; ALT and AST < 2.5 ULN
Exclusion criteria
Exclusion criteria: 1. Have received two or more chemotherapy regimens; 2. Refractory patients progressing in treatment; 3. Allergic to adriamycin and / or related substances or special heterogeneous reactions; 4. The expected accumulation of doxorubicin after four courses of doxorubicin hydrochloride liposome injection 5. History of doxorubicin liposome therapy in the past half a year; 6. Previous local radiotherapy of pelvis or lower abdomen; 7. Currently or recently (within 30 days before enrollment) using another study drug or participating in another clinical study; 8. Other malignancies (sufficiently treated squamous carcinoma of the cervix or squamous cell carcinoma of the skin, or controlled basal cell carcinoma of the skin) occurred within 5 years; 9. People with high blood pressure who cannot be reduced to the normal range by antihypertensive drugs (systolic blood pressure 140 mmHg or diastolic blood pressure >=90 mmHg); 10. Arrhythmia with poor grade II or higher myocardial ischemia or myocardial infarction, poor control (including QTS interval men >=450 ms, women >=470 ms); 11. According to the NYHA criteria, grades III to IV cardiac insufficiency, or echocardiography, suggest left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5 ULN) with bleeding tendency or receiving thrombolytic or anticoagulant therapy; 13. Significant clinically significant hemorrhagic symptoms or clear bleeding tendency within the first 3 months of randomization, such as gastrointestinal hemorrhage, hemorrhagic gastric ulcer, baseline fecal occult blood ++ and above, or vasculitis, etc.; Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks before randomization; 14. Has significant influence on oral drug absorption factors such as inability to swallow, chronic diarrhea, and intestinal obstruction; 15. There are obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction. Or sinus or perforation of empty organs within 6 months; 16. Urinary cues suggest urinary protein = ++, or confirm 24-hour urine protein >= 1.0 g; 17. Uncontrollable arrhythmias or other ECG abnormalities judged by the main researchers to be at risk; 18. The investigator judges other situations that may affect the conduct of clinical research and the findings of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall surival(OS);Objective response rate(ORR);disease control rate(DCR), including CR, PR, SD;safety; | — |
Countries
China
Contacts
Public ContactLingying WU
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed