The Efficacy and Safety of TAS-102(Suyuan) Combined With Bevacizumab as First-line Therapy in Patients With Advanced Colorectal Cancer

Inclusion criteria

• Age ≥18 years
• Life expectancy of at least 3 months
• Definitive histological or cytological evidence of adenocarcinoma of the colon or rectum;
• Patients who had not previously received first-line chemotherapy or targeted therapy for metastatic colorectal cancer, or who had received adjuvant chemotherapy after radical resection and had relapsed 12 months after completion of adjuvant chemotherapy;
• Patients who can not or can not tolerate combination chemotherapy.
• ECOG performance status was PS ≤2;
• According to RECIST Version 1.1, at least 1 measurable metastatic lesion was present;
• Appropriate organ function according to laboratory test values obtained within 7 days prior to administration of the study drug on Day 1 of Cycle 1.

A .The hemoglobin value was more than 90 g/L. B. The absolute neutrophil count was > 1.500 MM3. C. Platelet count was > GT; 100,000/mm (> GT; 100 * 10 ° L) . D. Total serum bilirubin was 1.5 x upper limit of normal (ULN) . E.Don't L-aspartic Acid aminotransferase (asgot) and endolaminic aminotransferase (Alt SGPT)≤2.5 x upper limit of normal (ULN) , and AST and ALT ≤5 x ULN if abnormal liver function is due to basal liver metastasis.

F. Serum creatinine ≤1.5 x upper limit of normal (ULN) or creatinine clearance ≥50 ml/min;.

G.Adequate coagulation: international standard ratio (INR) or prothrombin time (PT)≤1.5 times the upper limit of normal;. Urine or serum pregnancy tests were negative within 7 days of randomization.

• Women at risk of pregnancy must agree to use adequate contraception during the study until 6 months after the cessation of the study drug; Men had to agree to use adequate contraception during the study until six months after the study drug was discontinued.
• Willing and able to follow research protocols and visit plans.

Exclusion criteria

• The existence of serious diseases and serious medical conditions, this includes, but is not limited to, the following:

• the presence of other active malignancies at the same time, excluding those that have not been diagnosed for more than 5 years or are considered curable with adequate treatment,
• the known presence of brain or pial metastases,
• systemic active infection (ie, infection leading to body temperature ≥38 ° C-RRB- ,
• clinically significant intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or symptomatic cerebrovascular disease,
• uncontrolled diabetes;
• patients who have experienced any arterial thrombosis, embolism, or ischemic or hemorrhagic disease in the last 6 months and have not improved after appropriate treatment, such as unstable myocardial infarction, unstable angina, cerebrovascular accident after treatment,
• severe/unstable angina, NYHA Class III or IV symptomatic congestive heart failure,
• clinically significant gastrointestinal bleeding,
• known presence of human immunodeficiency virus (HIV) or acquired conventional immunodeficiency syndrome (AIDS)-related disease, or active hepatitis B or C,
• presence of psychiatric disorders that may increase the risk of participating in the study or taking research drugs, or that may interfere with the interpretation of the study results;
• patients with grade 2 or more hypertension before treatment who had not improved or were unstable with antihypertensive drugs,
• patients with nephrotic syndrome or with proteinuria ≥2 + or more before treatment who had not improved or were unstable after treatment, 13-RRB- patients with a history of gastrointestinal perforation in the last 6 months,
• patients with Hypertensive crisis hypertensive encephalopathy. 2.Any of the following treatments were performed within a specific time frame prior to study drug administration,

1）major surgery (laparotomy, thoracotomy, and evisceration by laparoscopy) was performed within the previous 4 weeks. Switch surgery was not included) ; 2) had received extended-range radiotherapy within the previous 4 weeks or had received limited-range radiotherapy within the previous 2 weeks; 3) had received any investigational medication within the previous 4 weeks. 3. Neurotoxicity of CTCAE grade 2 or above that has not subsided as a result of adjuvant therapy, 4. A pregnant or lactating woman. 5. The researchers did not consider it appropriate to enter the study.