colorectal cancer
Conditions
Interventions
Case series:Preoperative apatinib combined with S-1, for the maintenance of postoperative S-1
Sponsors
Guangyuan Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Man or woman:=18 years old; 2. Patients with colorectal cancer diagnosed as initial or relapsed by pathology and / or histology; 3. Patients in clinical stages II T4N0-2M0, cT1-3N2M0?M1(Liver metastasis only); 4. ECOG performance status score: 0-1;5.expected survival time =3 monthes;6.he main organ function is good, patients must meet the following requirements with 14 days before using Apatinib: (1) blood routine examination: hemoglobin> 90 g / L (14 days without blood transfusion); neutrophil count> 1.5 x 109/L; platelet count> 100×10^9/L; (2) biochemical examination: total bilirubin = 1.5 × ULN (normal upper limit); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2 × ULN; Endogenous creatinine clearance = 60 ml / min (Cockcroft-Gault formula); (4) Cardiac Doppler Ultrasonography: Left ventricular ejection fraction (LVEF) = 50%. 7. Sign informed consent; 8. Have not received pre-treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.), or from the end of the last pre-treatment has been more than 12 months.
Exclusion criteria
Exclusion criteria: 1. previously or simultaneously with other malignancies, but have been cured of skin and basal cell carcinoma except in situ carcinoma of the cervix; 2. Have a variety of factors that affect the oral medication (such as can not swallow, chronic diarrhea and intestinal obstruction, etc.); 3. Have a history of bleeding, any serious grade within 4 weeks prior to screening reaches a grade 3 or greater bleeding event in CTCAE4.0; 4. Known before the screening of central nervous system metastases or patients with a history of central nervous system metastases. For patients with clinically suspected central nervous system metastases, CT or MRI must be performed within 28 days prior to enrollment to exclude CNS metastasis; 5. Patients with hypertension who were not well controlled by a single antihypertensive medication (systolic> 140 mmHg, diastolic> 90 mmHg); those with a history of unstable angina; newly diagnosed angina within 3 months prior to screening Or myocardial infarction within 6 months prior to screening; arrhythmic (including QTcF: men =450 ms, women =470 ms) long-term use of antiarrhythmic drugs and NYHA Class =II grade cardiac insufficiency; Urine routine urinary protein = ++ and confirmed 24-hour urine protein> 1.0 g; Long-term non-healing wounds or incomplete healing fractures; 8. Imaging studies have shown that the tumor has been infringing on the important perivascular or the researchers determine the patient's tumor during treatment has the highest possible invasion of important blood vessels caused by fatal bleeding; 9. Patients with abnormal coagulation and bleeding tendency; Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; On the premise of an International Normalized Ratio (INR) = 1.5 for prothrombin time , Allows the use of low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (no more than 100 mg daily) for preventive purposes; 10. A / V thrombotic events such as cerebrovascular accident (including transient ischemic attack) and deep venous thrombosis (including venous thrombosis due to previous chemotherapy) are excluded within one year prior to screening, except those judged by the investigator to be cured ) And pulmonary embolism; 11. For female subjects: Patients who are surgically sterile, post-menopausal, or who consent to the use of a medically accepted contraceptive during and after the end of the study period; Serum or urine pregnancy tests must be negative within 7 days and must be non-lactating. Male subjects: Patients who have been surgically sterilized or who agree to adopt a medically accepted contraceptive method within the study period and within 6 months after the end of the study period; 12. Persons who have a history of abuse of psychotropic substances who can not be abstinent or who have mental disorders; 13. Has a history of immunodeficiency, or other acquired, congenital immunodeficiency disease, or have a history of organ transplantation; 14. At the investigator's discretion, there are serious concomitant diseases that endanger patient safety or affect the completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total resection rate (R0 / R1 / R2);Two-year disease-free survival rate;Safty;PFS;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS; | — |
Countries
China
Contacts
Public ContactLing Fan
Guangyuan Central Hospital
Outcome results
None listed