Bioequivalence Study Bevacizumab Biosimilar (BEVZ92) Versus Bevacizumab (AVASTIN®) in First-line Treatment mCRC Patients

Exclusion Criteria

• •1. Prior treatment for advanced or metastatic colorectal cancer.
• •2. Prior treatment with an anti-angiogenesis agent, in either the neoadjuvant or adjuvant setting.
• •3. Concurrent use of investigational anti-neoplastic agents (including up to 4 weeks prior to enrolment).
• •4. History of any other malignancy unless the malignancy is in complete remission and the patient has been off all therapy for that malignancy for at least 5 years.
• •5. Chronic treatment with systemic steroids or other immunosuppressive agents; topical or inhaled corticosteroids are allowed.
• •6. Scheduled immunization with attenuated live vaccines during study period or within 1 week prior to study entry.
• •7. Uncontrolled brain or lepto-meningeal metastases, including patients who continue to require glucocorticoids for brain or lepto-meningeal metastases.
• •8. Patients with active bleeding or history of bleeding diathesis on oral anti-vitamin K medication (except low dose coumadin) within the past 6 month prior to randomization or coagulopathy.
• •9. Patients with history of cerebral vascular accident, transient ischemic attack, or subarachnoid haemorrhage within the past 6 month prior to randomization.
• •10. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
• •11. Patients with serious non-healing wound, ulcer, bone fracture, or with a major surgical procedure, or significant traumatic injury within 4 weeks prior to randomization
• •12. Patients with clinical symptoms or signs of gastrointestinal obstruction that require parenteral hydration and/or nutrition.
• •13. Patients with history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization.
• •14. Patients with history of hypersensitivity to any of the study drugs or ingredients.