Colorectal cancer
Conditions
Interventions
Case series:Apatinib Mesylate Tablets of joint mFOLFOX6 neoadjuant chemotherapy
Sponsors
Tianjin people's hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Greater than or equal to 18 years old; 2. Pathology confirmed colorectal cancer patient; 3. The ECOG physical status score 0 ~ 1; 4. Did not receive colorectal cancer radical operation; 5. There is no difficulty swallowing, Can swallow oral drugs. 6. Preoperative did not make any radiation and chemotherapy and immunotherapy, such as 5 - Fu/LV. Capecitabine single medicine; 5 - Fu/LV/oxaliplatin into (FOLFOX); Capecitabine and oxaliplatin into (XELOX); 7. The late (T4N2M0) in patients with colorectal cancer; 8. Haven't received Apatinib for or other VEGFR inhibitors, such as beacizumab, sorafenib, chougny for treatment; 9. According to RECIST 1.1 standard, patients with at least one measurable lines of target lesion (tumor lesions on CT/MRI scan length to diameter 10 mm, or lymph node lesions on CT/MRI scans short diameter 15 mm or higher, scanning layer is not more than 7.5 mm thick; and none of them has received topical treatment); 10. Expected survival period for 3 months or more; 11. Main organs function is good, within 14 days before the random checks associated indicators meet the following requirements: 1) blood routine inspection: hemoglobin > 90 g/L; neutrophil count > 1.5 x 10^9/L; the platelet count > 100 x 10^9/L; 2) biochemical tests: total bilirubin acuities =1.5 x ULN (upper limit of normal); blood alanine aminotransferase (ALT) or blood aspertate aminotransferase (AST) =2 x ULN ; the endogenous creatinine clearance =60 ml/min (Cockcroft - Gault formula); 3) Heart doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = 50%; 12. Women of child-bearing age should be carried out in the group of 7 days before the pregnancy test (serum or urine), and the results were negative, and willing to during the test and the last for 8 weeks after experimental drug using appropriate methods of contraception; 13. Sign the informed consent; 14. Good compliance, family members agree to cooperate in survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Before or at the same time with other malignant tumor, But not including has been cured the skin basal cell carcinoma and cervical carcinoma in situ; 2. Four weeks attended other drug clinical trials; 3. Has a variety of factors influencing oral drugs (such as unable to swallow, chronic diarrhea and intestinal obstruction, etc.); 4. A history of bleeding, screening occurred within 4 weeks before any serious grading achieve CTCAE4.0 3 degrees or above of bleeding events; 5. Before the screening,Known to have the central nervous system transfer or patients with a history of the central nervous system transfer.In patients with clinical suspected transfer central nervous system,Within 28 days before the trial must be CT or MRI, move out of the central nervous system; 6. Have high blood pressure and the single antihypertensive drug treatment can't obtain good control(systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg) A history of unstable angina; 3 months prior to screening newly diagnosed with angina pectoris or Six months before the screening Myocardial infarction incidents;Arrhythmia (including QTcF: male acuity 450 ms, women 470 ms or higher) Long-term use of anti-arrhythmic drugs and New York heart association class II or higher cardiac insufficiency; 7. Routine urine prompt urine protein = + + and confirmed that the 24 hours urinary protein quantitative > 1.0 g; 8. Imaging showed cancer has invaded the important blood vessels Or by the researchers determine patients during treatment of tumor with high may invade the important blood vessels and cause fatal bleeding; 9. Coagulant function abnormality, with bleeding tendency (14 days before randomization must satisfy: in the case of without the use of anticoagulants INR within the normal range). Application of anticoagulant or vitamin K antagonists such as warfarin, heparin, or its analogues treatment; 10. A history of immunodeficiency,or has other acquired, congenital immunodeficiency disease, or has a history of organ transplantation; 11. According to the researcher's judgment, there is serious to endanger the safety of patients or patients completed the research associated with disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic complete response;Objective response rate;Drop period to ensure operation resection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rates;Disease-free survival;Anal rate; | — |
Contacts
Public ContactQin Hai
Tianjin people's hospital
Outcome results
None listed