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

Inclusion Criteria

• Patient must not have had prior chemotherapy for advanced or metastatic disease. Patients could have received adjuvant chemotherapy or adjuvant chemo-radiotherapy.
• Patient with mCRC for whom bio-chemotherapy is indicated.
• Patients must have at least one measurable non-irradiated site of disease according to RECIST (version 1.1) criteria. If the patient has had previous irradiation of the marker lesion(s), there must be evidence of progression since the radiation.
• Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Adequate bone marrow function
• Adequate liver function defined within specific parameters
• Adequate renal function defined within specific parameters
• Adequate coagulation parameters defined within specific parameters
• Negative pregnancy test for females of a childbearing potential.
• Use of an effective form of contraception during the study (for subjects of childbearing potential and their partners).
• Life expectation ≥ 3 months

Exclusion Criteria

• Prior treatment for advanced or metastatic colorectal cancer.
• Prior treatment with an anti-angiogenesis agent, in either the neoadjuvant or adjuvant setting.
• Concurrent use of investigational anti-neoplastic agents (including up to 4 weeks prior to enrolment).
• 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.
• Chronic treatment with systemic steroids or other immunosuppressive agents; topical or inhaled corticosteroids are allowed.
• Scheduled immunization with attenuated live vaccines during study period or within 1 week prior to study entry.
• Uncontrolled brain or lepto-meningeal metastases, including patients who continue to require glucocorticoids for brain or lepto-meningeal metastases.
• 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.
• Patients with history of cerebral vascular accident, transient ischemic attack, or subarachnoid haemorrhage within the past 6 month prior to randomization.
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
• 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
• Patients with clinical symptoms or signs of gastrointestinal obstruction that require parenteral hydration and/or nutrition.
• Patients with history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization.
• Patients with history of hypersensitivity to any of the study drugs or ingredients.