A Prospective, Randomized, Multiple-Dose, Multi-Center, Comparative, Parallel Clinical Study to Evaluate the Efficacy, Safety, Immunogenicity and Pharmacokinetics of an Intravenous Infusion of Bevacizumab (Test product, Hetero) and Reference Medicinal Product (Reference product, Roche) Administered in Combination with Standard Chemotherapy in Patients of Metastatic Colorectal Cancer

Hetero Drugs Limited0 个研究点目标入组 137 人开始时间: 待定最近更新: 2021年11月24日

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•1. Histologically pre-confirmed metastatic colorectal carcinoma, and not suitable for radical surgery, or radiotherapy at the inclusion time
•2. No known brain metastases
•3.Performance status - ECOG 0 to 2
•4.Life expectancy >= 6 months
•5.Major surgery, open surgical biopsy or significant traumatic injury at least 4 weeks before randomization. If post-operative, recovered from the effects of surgery
•6.No plan to administer radiation therapy or perform surgery for target lesions during study treatment. (Palliative surgeries or radiation therapy for non-target lesions allowed).
•7.INR <= 1.5 and aPTT <= 1.5 x ULN within 21 days prior to starting study treatment.
•8.Adequate liver function: Serum bilirubin <= 1.5 x ULN; alkaline phosphatase and transaminases <= 2.5 x ULN (in case of liver metastases < 5 x ULN)
•9.Adequate bone-marrow function
•10.Ability to comply with study and follow-up procedures and provide written informed consent

•1. Drug allergy, hypersensitivity or intolerance: Known or suspected allergy or hypersensitivity to any component of Bevacizumab
•2. Any anticancer treatment (chemotherapy, hormonal treatment, radiation treatment, surgery, immunotherapy, biologic therapy or tumor embolization) within 4 weeks before randomization3. Presence of a serious, non-healing wound, ulcer, or bone fracture
•3. Chronic, actual or recent use (10 days prior to first drug administration) of acetylsalicylic acid (aspirin) >325 mg/day or clopidogrel (75 mg/day) or other treatments that can cause gastrointestinal ulcer (low-dose aspirin is permitted < or equal to 325 mg/day)
•4. History of stroke or transient ischemic attack within 6 months prior to study enrolment
•5. History or clinical evidence of uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg on repeated measurement) despite optimal medical management
•6. Cardiac arrhythmia
•7. Any medical, psychological, or social condition that may interfere with the subjects participation in the study or evaluation of the study results

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