Late-stage platinum resistant ovarian cancer
Conditions
Interventions
treatment group:Apatinib + chemotherapy
control group:Pure chemotherapy
Sponsors
Xijing Hospital affiliated to The Fourth Military Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged greater than 18; 2. In patients with advanced ovarian cancer, there is at least one measuring lesion (MRI or CT scan with a length of 10 mm, which meets the RECIST1.1 standard); Note: if the patient has no measurable lesions, but has observed lesions, according to various researchers at the centre of the comprehensive evaluation, can into the group, main is to observe the tumor markers and the quality of life, but not included in the objective evaluation of curative effect. 3. Patients who had received treatment with a platinum-containing chemotherapy regimen (which had relapsed within 6 months of treatment or after completion); 4. ECOG scores: 0-2 points; 5. The period of survival is expected to be greater than that of march; 6. The damage from other treatments had been recovered, with the interval between nitrocellulose or mitomycin for up to six weeks. To receive other cytotoxic drugs, radiation or surgery for four weeks, and the wound has healed completely; 7. The main organ function is normal, which meets the following criteria: (1) the standard of blood test should be met (14 days without blood transfusion and blood products, no g-csf and other hematopoietic stimulation factor correction): HB is equal to 90 g/L; The ANC is greater than 1.5 times 10^9/L; PLT is greater than 80x109 / L; (2) biochemical inspection shall meet the following criteria: TBIL 45 ml/min (the Cockcroft Gault formula); 8. The subjects volunteered to participate in the study and signed informed consent forms, adherence to sex and follow-up.
Exclusion criteria
Exclusion criteria: 1. People with high blood pressure and can not be reduced to a normal range (systolic > 140 mmHg, diastolic > 90 mmHg). A person with a history of unstable angina; In the first 3 months of screening, the new diagnosis was a cardiac myocardial infarction in the first six months. Cardiac arrhythmias (including QTcF greater than 470 ms) require long-term use of arrhythmias and the New York heart association (New York heart association); 2. Factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 3. The coagulant function abnormality (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency is used anticoagulants or vitamin K antagonists such as warfarin and heparin or its analogues treatment; The international standardized ratio (INR) of the thrombin time (INR) is less than or equal to 1.5 (1)) or small doses of aspirin (no more than 100 mg per day); 4. The central nervous system with symptoms and activity is transferred; 5. Having a history of mental abuse that cannot be taken off or mental disorders; 6. Having a clinically difficult infection or HIV infection; 7. Participating in clinical trials of other drugs within four weeks; 8. The researchers judged other conditions that could affect clinical research and the results of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Tumor markers;Disease control rates;Relief time;Objective response rate;The quality of life; | — |
Countries
China
Contacts
Public ContactYang Hong
Xijing Hospital affiliated to The Fourth Military Medical University
Outcome results
None listed