A Multi-center Observational Study of Bevacizumab Plus 5-FU Based Chemotherapy as First Line and Second Line Treatment for Chinese Patients With Metastatic Colorectal Cancer (ML25391)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 609
- 主要终点
- Percentage of Participants With Adverse Events of Special Interest
研究概览
简要总结
This observational study will evaluate the safety and efficacy of Bevacizumab in combination with 5-Fluorouracil based chemotherapy as first-line and second-line therapy in Chinese participants with metastatic colorectal cancer. Data will be collected from each participant for up to 3 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Chinese participants, >/= 18 years of age
- •Histologically confirmed and previously untreated metastatic colorectal cancer
- •Initiated on treatment with Bevacizumab (in combination with 5-FU based chemotherapy) according to locally approved Bevacizumab China package insert
- •Documented participant with medical records
排除标准
- •Recent history of serious hemorrhage or hemoptysis of >/= 1/2 teaspoon of red blood
- •Proteinuria at baseline (>/=2 grams / 24 hours)
- •Major surgical procedure within 28 days prior to study treatment start, not fully healed wounds
- •Pregnant or lactating women
结局指标
主要结局
Percentage of Participants With Adverse Events of Special Interest
时间窗: 36 months
Percentage of Participants With Serious Adverse Events
时间窗: 36 months
A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose was fatal, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant, or required intervention to prevent one or other of the outcomes listed above.
Percentage of Participants With Adverse Events
时间窗: 36 months
An adverse event (AE) is defined as any untoward medical occurrence in a participant after administration of a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.
Percentage of Participants With Bevacizumab-Related Adverse Events
时间窗: 36 months
Percentage of Participants With Bevacizumab-related Serious Adverse Events
时间窗: 36 months
次要结局
- Progression-free Survival(36 months)
- Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup(Up to 36 Months)
- One-year Survival Rate by the Chemotherapy Regimen Subgroup(1 year)
- One-year Survival Rate by the KRAS Subgroup(1 year)
- Percentage of Participants Achieving an Overall Response(36 months)
- One-year Survival Rate(1 year)
- One-year Progression-free Survival Rate(1 year)
- Percentage of Participants Achieving an Overall Response Per Kirsten Rat Sarcoma Viral (KRAS) Oncogene Subgroup(36 months)
- One-year Progression-free Survival Rate Per KRAS Subgroup(1 year)
- One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup(1 year)
- Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire(Up to 36 Months)