cervical carcinoma
Conditions
Interventions
Case series:Apatinib
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female, age =18 years; 2. ECOG(Eastern Cooperative Oncology Group) :0~2; 3. Patients must have a life expectancy of at least 3 months; 4. Histologically or pathologically confirmed diagnosis of recurrent or metastatic cervical cancer; 5. Recurrence after the treatment of radiotherapy and first-line chemotherapy;and the latest radiotherapy must be completed for at least 4 weeks before screening,the latest first-line chemotherapy must be completed for at least 6 weeks before screening; 6. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version; 7. No considering other targeted drugs; 8. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function ). For example: HB=90 g/L, ANC>1.5×109/LPLT>75×109/L, TBIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value(Liver metastasis:<5×ULN), and CR=1.25 ×ULN 9. Patients will take contraceptive measures for the duration of the treatments and 8 weeks after the last treatment; 10. Signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. With bilateral hydronephrosis; 2. Active brain metastases, meningitis, cancer patients with spinal cord compression, CT or MRI examination revealed brain or soft meningeal disease (21 days before the drug treatment; the symptoms of patients with brain metastases from stable can into the group, but need to be confirmed by the cerebral MRI, CT or vein imaging evaluation for no symptoms in cerebral hemorrhage); 3. Patients with poor blood pressure control (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg ); 4. Patients with stage II myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QT interval male = 450 ms, female = 470 ms) and Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or is treated with thrombolysis and anticoagulation 6. A large of dropsy of serous cavity(including pleural effusion, ascites, pericardial effusion, etc.); 7. Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening; 8. Having a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 9. With abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months before screening; 10. Patients whose routine urine tests indicate that urine protein = ++ or verifies that the 24-h urine protein quantitation = 1.0 g; 11. Having a history of psychiatric abuse and can not quit or have mental disorders; 12. Patients with basal cell carcinoma,Carcinoma in situ of the cervix and superficial bladder cancer; 13. Pregnant and lactating women; 14. Other situations that the researchers considered unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DCR;ORR;QoL;Safety; | — |
Countries
China
Contacts
Public ContactHanmei Lou
Zhejiang Cancer Hospital
Outcome results
None listed