| Eligibility |
Inclusion Criteria:
1. Age 18-75 years
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
3. Life expectancy = 6 months
4. Histologically confirmed colorectal cancer with a metastatic / recurrent lesion that
cannot be cured by surgery.
5. At least one measurable lesion have been the confirmatory detection within 4 weeks
prior to the randomization with respect to RECIST 1.1
6. No prior first-line systemic anti-tumor therapy for mCRC (including systemic
chemotherapy, molecular targeted therapy, biotherapy, and other study treatment) have
been identified
7. At least 6 months have elapsed if considering the interval from the time of firstly
documented metastasis to the post-operational adjuvant chemotherapy termination
8. Adequate organ function as indicated by the following laboratory values:
1. Absolute neutrophil count (ANC) =1,500 /mm3(1.5×109 /L)
2. Platelets =80,000 / mm3(80×109 /L)
3. Hemoglobin =9 g/dL, within the 2 weeks prior to the screening no need for the
transfusion
4. Serum creatinine =1.5 X upper limit of the normal (ULN) or creatinine clearance =
50 mL/min according to Cockcroft-Gault formula
5. Serum total bilirubin = 1.5 X ULN
6. AST (SGOT), ALT (SGPT) and alkaline phosphatase (ALK) = 3 X ULN (AST/ALT = 5 X
ULN if liver metastatic; ALK = 5 × ULN if liver and/or bone metastastic)
7. International Normalized Ratio (INR) or Prothrombin Time (PT) or Activated
Partial Thromboplastin Time (aPTT) = 1.5 X ULN; ( if patient is receiving
anticoagulant therapy as long as PT or PTT is within therapeutic range of intent
using goal of anticoagulants)
9. The subjects are accredited with good compliance, signed the informed consent, and
capable to cooperate, completing the relevant examination and follow-ups.
Exclusion Criteria:
1. Targeted medicine(including Bevacizumab, cetuximab, panedol, arbicip, rigofeni, etc)
was used before as adjuvant therapy.
2. Cerebral and/or leptomeningeal metastasis.
3. Bleeding predisposition, high bleeding risk or coagulant disorder, thrombotic event(s)
occurrence =6 months and/or hemoptysis =3 months (= 1/2 teaspoons fresh blood each)
prior to the screening; use of full dose oral or parenteral anticoagulant or
thrombolytic medication (allowing preventative anticoagulation); use of aspirin (> 325
mg/day) or other platelet-inhibition non-steroidal anti-inflammatory drugs within 10
days since the screening; CT/MRI imaging evidence, testimony of the main
arteries/veins (such as pulmonary artery or superior vena cava) being infringed,
encroached.
4. Subjects with uncontrolled hypertension and with a medical history of hypertensive
crisis or hypertensive encephalopathy; serious cardiovascular and cerebrovascular
diseases, including cerebrovascular accident (CVA) =6 months before the screening,
transient ischemic attack (TIA), myocardial infarction and significant vascular
disease (including but not limited to aortic aneurysms with need for surgical repair
or recent evidence of arterial thrombosis), unstable angina, heart failure and serious
arrhythmias that are uncontrolled by drugs (New York Heart Association Class =2).
5. Subjects with non-healing wounds, active peptic ulcer or fracture and active
infection; tracheal esophageal fistula, gastrointestinal perforation or
gastrointestinal fistula and abdominal abscess in the 6 months prior to the
screening;Uncontrolled infection,including HIV,HBV,HCV and syphilis .
6. Subjects allergic to bevacizumab, oxaliplatin, 5-FU/capecitabine or folinic acid
injection and the relevant ingredients and excipients.
7. Pregnant women and lactating women; women of potential childbearing age and male
subjects do not use effective contraception during the study period, and during the 6
months after the last study drug administration effective contraception cannot be
assured.
8. Presence of other active malignancies or a history of other malignancies within the
past 5 years, except for carcinoma in situ of the cervix, basal cell carcinoma or
squamous cell carcinoma of the skin that has been previously treated with curative
intent.
9. Subject is currently enrolled in, or =4 weeks since subject participating another
investigational device or drug study(s), or subject is receiving other investigational
agent(s).
10. Any other medical condition that renders disqualification for the inclusion in the
study according to the investigator discretionary judgment.
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