Safety Study of Bevacizumab Plus Chemotherapy To Treat Metastatic Colorectal Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To assess the safety profile of bevacizumab in combination with chemotherapy for the treatment of metastatic colorectal cancer

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborator: Proswell Medical Corporation
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• with histologically confirmed metastatic colorectal cancer

• patients with metastatic colorectal cancer who are eligible for Bevacizumab in combination with chemotherapy treatment

• Written informed consent

• Unlimited line of treatment (first-line or second line is not limited)

Exclusion Criteria:

Patients who are not eligible for Bevacizumab treatment according to locally approved Bevacizumab China package insert will be excluded. The following patients are not eligible for Bevacizumab treatment according to local Bevacizumab China package insert:

• Recent history of serious hemorrhage or hemoptysis of ≥1/2 teaspoon of red blood

• Proteinuria at baseline: Patients discovered to have ≥ 2 grams of proteinuria/24 hours *

• The measurement of 24-hour proteinuria level is recommended for patients with moderate to high proteinuria risk indicated by clinical judgement. The treatment with bevacizumab should be delayed when proteinuria is ≥2g/24 hours.

• Major surgical procedure within 28 days prior to treatment initiation, or not fully healed wounds

• Pregnant or lactating women

• Excluding patients known to be allergic to bevacizumab or any of the excipients