Safety Study of Bevacizumab Plus Chemotherapy To Treat Metastatic Colorectal Cancer

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

Detailed Description
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This is a multi-centre, observational, non-interventional study. Patients with metastatic colorectal cancer eligible for Bevacizumab in combination with chemotherapy treatment will be enrolled in this trial.

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: bevacizumab


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bevacizumab Plus Chemotherapy<br> | Drug: bevacizumab<br>* 5 mg/Kg, IV (in the vein) on day 1 and day 14 of each 28 day cycle. Number of Cycles: until progression.<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence, nature and severity of adverse events of special interest | Gastrointestinal perforation, thromboembolic event, wound healing complication, bleeding, hypertension and proteinuria | Four years | 
| Incidence, nature and severity of bevacizumab related serious adverse events |  | Four years | 
| Onset time of adverse event associated with bevacizumab |  | Four years | 
| Laboratory parameters | Complete blood cell count, electrolytes, hepatic and renal function, coagulation parameters, urinalysis or urine protein | Four years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Time from the diagnosis of colorectal cancer to death due to various causes. Patients who do not die at the end of study will be truncated when they do not die at the last collection. | Four years | 
| Overall response rate (ORR) of treatment line | The best overall response status determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria is defined as the best response status recorded from the enrollment to disease progression (the minimal measurement from baseline assessment is used as the reference for progression). ORR includes complete response (CR) and partial response (PR). The value of change will be summarized according to different treatment lines. | Four years | 
| Progression-free survival (PFS) of treatment line: | Time from the enrollment to disease progression or death due to various causes, whichever is earlier (Disease progression is according to RECIST 1.1 criteria for tumor assessment). Patients who do not have disease progression or death at the end of study will be truncated at the last tumor assessment. The value of change will be summarized according to different treatment lines. | Four years | 
| One-year disease-free progression rate of treatment line | The proportion of patients without disease progression within one year since enrollment or with death for other reasons based on analytical population. The value of change will be summarized according to different treatment lines. | One year | 
| One-year survival rate of treatment line | The proportion of patients without death within one year since enrollment based on analytical population. The value of change will be summarized according to different treatment lines. | One year | 
| Overall survival (OS) of treatment line | Time from the enrollment to death due to various causes. Patients who do not die at the end of study will be truncated when they do not die at the last collection. | Four years |