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| Name | Class |
|---|---|
| Proswell Medical Corporation | INDUSTRY |
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To assess the safety profile of bevacizumab in combination with chemotherapy for the treatment of metastatic colorectal cancer
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab Plus Chemotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Drug | 5 mg/Kg, IV (in the vein) on day 1 and day 14 of each 28 day cycle. Number of Cycles: until progression. |
|
| 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 |
| 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 |
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Inclusion Criteria:
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 *
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
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Patients with histologically confirmed metastatic colorectal cancer are eligible
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruihua Xu, Professor | Contact | +86-20-87343804 | xurh@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University Cancer Center | Recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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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 |
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450008 | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| Liaoning Cancer Hosptial & Institute | Recruiting | Shenyang | Liaoning | 110042 | China |
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| The Second People's Hospital of Sichuan | Recruiting | Chengdu | Sichuan | 610041 | China |
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| First Affiliated Hospital of PLA General Hospital | Recruiting | Beijing | 100048 | China |
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| Chinese PLA General Hospital | Recruiting | Beijing | 100853 | China |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |