ovarian cancer
Conditions
Interventions
Experimental group:anlotinib hydrochloride combined with Paclitaxel one week therapy
Sponsors
The Second Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily joined the study and signed an informed consent form. 2. Female patients aged 18 to 75 years. 3. Epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer diagnosed by pathology. 4. After cytoreductive surgery, you have received platinum-containing regimen treatment, and the disease recurrence/progression during the platinum-containing regimen treatment period or the time from platinum-containing treatment (at least 4 cycles) to disease recurrence/progression is less than 6 months (184 calendar days): (1) Definition of recurrence progression (satisfying any of the following conditions): There is clearly recorded imaging progress, CA125 continues to rise (confirmed after 1 week) and clinical symptoms or physical examination suggest disease progression; (2) It is allowed to receive no more than one non-platinum regimen between two platinum-containing regimens; (3) Patients with disease recurrence/progression during the treatment of platinum-containing regimens or patients whose time from platinum-containing treatment (at least 4 cycles) to disease recurrence/progression is less than 6 months (184 calendar days) have not received subsequent systemic treatment regimens. 5. There is at least one measurable lesion (according to the requirements of RECIST v1.1, the long diameter of the spiral CT scan of the measurable lesion is >=10 mm or the short diameter of enlarged lymph node is >=15 mm; the lesions that have received radiotherapy or local treatment in the past, according to RECIST v1.1 can be used as a target lesion after clear progress). 6. Able to swallow pills normally. 7. ECOG score: 0-1 (see Annex 2 for ECOG scoring criteria). 8. Expected survival period >= 12 weeks. 9. The function of vital organs meets the following requirements (no blood components, cell growth factor corrective treatment drugs are allowed within 14 days before the medication): absolute neutrophil count >=1.5x10^9/L, platelet >=90x10^9/L , Hemoglobin >= 90 g/L, serum albumin >=30 g/L, bilirubin <=1.5xULN, ALT and AST <=3xULN, if there is liver metastasis, ALT and AST < 5xULN, serum creatinine <= 1.5xULN. 10. For non-surgical sterilization or female patients of childbearing age, it is necessary to use a medically approved contraceptive method after signing informed consent, during the study treatment period, and within 8 weeks after the end of the study treatment period; female patients of childbearing age who are non-surgically sterilized are in the study The blood HCG test within 72 hours before medication was negative; and it must be a non-lactating period.
Exclusion criteria
Exclusion criteria: 1. Past (within 5 years) or concurrently suffering from other uncured malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ and breast carcinoma in situ. 2. The patient has untreated central nervous system metastasis, and has previously received systemic, radical brain or meningeal metastasis therapy (radiotherapy or surgery), if imaging confirmed that the stability has been maintained for at least 1 month, and the whole body has been stopped Patients with sex hormone therapy (dose>10 mg/day prednisone or other curative hormones) for more than 2 weeks without clinical symptoms can be included. 3. Patients with clinical symptoms of pleural effusion, pericardial effusion or ascites who need puncture or drainage or those who have received treatment for the purpose of drainage within 1 month before medication. 4. Patients with gastrointestinal perforation, abdominal abscess, or recent (within 3 months before medication) intestinal obstruction or imaging, clinical symptoms suggest intestinal obstruction. 5. Suffer from high blood pressure and cannot be well controlled by antihypertensive drugs (systolic blood pressure >=140 mmHg or diastolic blood pressure >= 90 mmHg). 6. There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) New York Heart Association (NYHA) heart failure above grade 2; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Atrial fibrillation; clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; (5) PR interval> 250 ms or QTc>470 ms. 7. Abnormal coagulation function (INR>2.0 or prothrombin time (PT)>16 s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy (allowing the preventive use of low-dose aspirin, low molecular weight heparin). 8. There are clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before the medication, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or suffering from vasculitis, etc. If the stool occult blood is positive during the baseline period, it can be rechecked. If it is still positive after re-examination, combined with clinical judgment, perform gastroscopy if necessary. 9. Arterial/venous thrombosis events that occurred within 6 months before medication, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, superficial vein thrombosis by researchers After being judged, you can join the group. 10. Known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia patients, coagulation dysfunction, thrombocytopenia, etc.). 11. Accompanied by active ulcers, unhealed wounds or fractures. 12. Urine routine test showed urine protein >= ++ and confirmed 24-hour urine protein content> 1.0 g. 13. Patients who have previously received radiotherapy, chemotherapy or molecular targeted therapy, less than 4 weeks after the completion of the treatment (last medication) and before the study medication (for those with oral molecular targeted drugs less than 5 drug half-lives); adverse events caused by previous treatment ( Except for alopecia) those who have not recovered to =38.5 degree C within 7 days before medication, or baseline white blood cell count >15x10^9/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;overall survival;duration of relief;adverse events;quality of Life; | — |
Countries
China
Contacts
Public ContactZhao Hu
The Second Affiliated Hospital of Zhengzhou University
Outcome results
None listed