Safety Study of Bevacizumab Plus Chemotherapy To Treat Metastatic Colorectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 7
- 主要终点
- Incidence, nature and severity of adverse events of special interest
研究概览
简要总结
To assess the safety profile of bevacizumab in combination with chemotherapy for the treatment of metastatic colorectal cancer
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Bevacizumab Plus Chemotherapy
干预措施: bevacizumab (Drug)
结局指标
主要结局
Incidence, nature and severity of adverse events of special interest
时间窗: Four years
Gastrointestinal perforation, thromboembolic event, wound healing complication, bleeding, hypertension and proteinuria
Incidence, nature and severity of bevacizumab related serious adverse events
时间窗: Four years
Onset time of adverse event associated with bevacizumab
时间窗: Four years
Laboratory parameters
时间窗: Four years
Complete blood cell count, electrolytes, hepatic and renal function, coagulation parameters, urinalysis or urine protein
次要结局
- Overall survival (OS)(Four years)
- Overall response rate (ORR) of treatment line(Four years)
- Progression-free survival (PFS) of treatment line:(Four years)
- One-year disease-free progression rate of treatment line(One year)
- One-year survival rate of treatment line(One year)
- Overall survival (OS) of treatment line(Four years)
研究者
Ruihua Xu
vice president of SunYat-sen University Cancer Center,head of medical oncology department
Sun Yat-sen University