malignant tumour
Conditions
Interventions
experimental arm :Apatinib
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed recurrent or metastatic advanced malignant solid tumors (including, but not limited to, gastric cancer, colorectal cancer, lung cancer, hepatocellular carcinoma, breast cancer, osteosarcoma, soft tissue sarcoma, ovarian cancer, cervical cancer, etc.); 2. Having received at least two standard chemotherapy regimens for advanced malignancies previously (HCC patients are not included), or refusing or cannot tolerate chemotherapy or having no standard treatment; 3. The radiotherapy must be completed for at least 4 weeks before screening , and the acute toxicity produced by previous radiotherapy must be restored; 4. Age at least 18 years old; 5. ECOG(Eastern Cooperative Oncology Group) 0~3; 6. The Expected lifetime:=3 month; 7. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: HB=90 g/L, ANC>1.5×10^9/L; PLT>100×10^9/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 CRE<1.2mg/dl 8. Patients will take contraceptive measures for the duration of the treatments and 8 weeks after the last treatment; 9. Signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by CT or MRI (Patients with a history of CNS metastases or cord compression are eligible if they are clinically stable at least 21 days before randomization); 2. Patients with poor blood pressure control (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg ); 3. 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; 5. Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening; 6. Have a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 7. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before screening; 8. Patients whose routine urine tests indicate that urine protein = ++ or verifies that the 24-h urine protein quantitation = 1.0 g; 9. Having a history of psychiatric abuse and can not quit or have mental disorders; 10. Patients with basal cell carcinoma,Carcinoma in situ of the cervix and superficial bladder cancer; 11. Pregnant and lactating women; 12. Other situations that the researchers considered unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| nutritional status;safety;tolerance; | — |
Countries
China
Contacts
Public ContactQinghua Yao
Zhejiang Cancer Hospital
Outcome results
None listed