Ovarian cancer
Conditions
Interventions
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients who voluntarily join the study and sign informed consent; 2. Patients who respond to initial platinum based chemotherapy but progress or relapse within 6 months after the completion of chemotherapy; 3. Patients aged 18-70 years; 4. Patients with ECOG-ps score of 0-2; 5. According to recist1.1, patients with clinically assessable lesions, the maximum diameter of metastasis >= 1cm, lymph node metastasis >= 1.5cm, and the target lesions are not suitable for surgical treatment; according to the GCIG CA125 standard, the baseline CA125 level was twice higher than the upper limit of the normal value (> 70u / ml) at the time of enrollment; patients with the target lesions not receiving radiotherapy or recurred in the radiotherapy field; 6. Patients with an estimated survival time of more than 4 months; 7. Patients whose main organ function indexes meet the conventional target and chemotherapy standards: neutrophil count >= 1.5 * 10^9 / L; platelet >= 90 * 10^9 / L; hemoglobin >= 90g / L; serum albumin >= 30g / L; bilirubin <= 1.5 * ULN; ALT and AST <= 3 * ULN (if there is liver metastasis, ALT and AST < 5 * ULN); serum creatinine <= 1.5 * ULN.
Exclusion criteria
Exclusion criteria: 1. Patients with platinum refractory (initially unresponsive to platinum based chemotherapy, such as tumor stabilization or tumor progression, including patients who progressed within 4 weeks after chemotherapy); 2. Patients who have previously received local radiotherapy of pelvis or lower abdomen; 3. Patients taking another study drug (including but not limited to endocrine therapy, hormone therapy) or participating in another clinical trial within 30 days before enrollment; 4. Patients who have had other malignant tumors within 5 years (except for cervical carcinoma in situ or squamous cell carcinoma of skin, or controlled basal cell carcinoma of skin); 5. Patients with hypertension who cannot be reduced to normal range after antihypertensive drug treatment (systolic pressure >= 140mmHg or diastolic pressure >= 90mmHg); 6. Patients with grade II or above myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc interval >= 470ms); according to NYHA standard, patients with grade III-IV cardiac insufficiency, or with left ventricular ejection fraction (LVEF) 1.5 or prothrombin time Pt > ULN + 4 seconds or APTT > 1.5uln) or undergoing thrombolysis or anticoagulation; 8. In the first 3 months, patients who had significant clinical bleeding symptoms or had obvious bleeding tendency, such as gastrointestinal bleeding, bleeding ulcer, occult blood in stool at baseline or above, or had vasculitis, etc.; 9. Patients who had undergone major surgery or had severe traumatic injury, fracture or ulcer within 4 weeks before admission; 10. Patients with significant factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction; 11. Patients with urinary protein >= 1.0g in 24 hours were confirmed; 12. Patients who have severe allergic reactions, are allergic to the drugs used in the study or have specific reactions; 13. The researcher judges other situations that may affect the clinical research and the judgment of the research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;ORR;OS;Adverse events; | — |
Countries
China
Contacts
Public ContactGuihua Sheng
Beijing Hospital
Outcome results
None listed