Metastatic colorectal cancer
Conditions
Interventions
single arm:apatinib
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. man or woman:18-70 years old; 2. Patients with colorectal adenocarcinoma who have been confirmed by cytology or histology and have metastatic colorectal cancer who have failed standard first- and second-line chemotherapy. (Patients who had failed treatment with standard chemotherapy using 5-Fu or capecitabine, oxaliplatin, and irinotecan.); 3. According to the RECIST 1.1 standard, the patient has at least one target lesion that can measure the diameter; 4. ECOG PS =2; 5. Expected survival time of more than 3 months; 6. The level of organ function must meet the following requirements: Bone marrow: neutrophil count (ANC) = 1.5×10^9/L, platelet = 75×10^9/L, hemoglobin = 90g/L; Liver: serum bilirubin = 2 times the upper limit of normal, aminotransferase AST and ALT = 2.5 times the normal upper limit; Kidney: Serum creatinine =1.5 times upper limit of normal; 7. Patient compliance is good; 8. Understand and voluntarily sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Other previous or concurrent malignancy, except cured skin basal cell carcinoma and cervical carcinoma in situ; 2. Already known to be allergic to apatinib or any excipient; 3. Use unapproved drugs or other test medications within 4 weeks prior to enrollment; 4. Many factors that affect oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction); 5. Patients with a history of CNS metastases or CNS metastases; 6. A history of bleeding, with any serious grading within 4 weeks prior to screening reaching a bleeding event of 3 degrees Celsius or greater in CTCAE4.0; 7. Patients with severe infections; 8. Serious cardiovascular disease: uncontrolled hypertension, unstable angina, grade 3-4 heart failure (NYHA standard), congestive heart failure; 9. urinary routine urinary protein = ++ and confirmed 24-hour urinary protein quantitation> 1.0 g; 10. Within 30 days after major surgery; 11. Thrombotic disease. Anemia or venous thrombosis occurred in the previous year, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, pulmonary embolism, etc.; 12. Those with history of psychotropic substance abuse who can not be abstinent or have mental disorders; m) Have clinical symptoms, need clinical intervention pleural effusion or ascites; n) At the investigator's discretion, there is a serious concomitant condition that compromises the patient's safety or affects the patient in completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DCR;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;Blood concentration;safety; | — |
Countries
China
Contacts
Public ContactLiyan Liu
West China Hospital, Sichuan University
Outcome results
None listed