Real-world Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie in First-line Treatment in Participants With Unresectable Metastatic Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 133
- 试验地点
- 14
- 主要终点
- Evaluate the effectiveness of treatment with bevacizumab
研究概览
简要总结
Colorectal cancer is one of the most common tumors and is the second most prevalent cause of cancer death, leading to almost 1 million deaths per year.Elovie is a bevacizumab biosimilar medicine marketed by Libbs Farmacêutica, which had its registration approved by ANVISA in May 2022.At the time of registration a robust evidence package was presented that included, for example, pharmacokinetic bioequivalence studies in patients with metastatic RCC (mRCC) and a phase III study in participants with non-small cell lung cancer .Conducting a real-world study to evaluate the effectiveness and safety of bevacizumab biosimilar Elovie in patients with mCRC is crucial to provide relevant information on how this therapy behaves in real-world clinical conditions in brazilian population.
详细描述
Observational, multicenter study with real-world data from specialized cancer centers in Brazil. Participants over 18 years of age, of both sexes, with unresectable clinical stage IV metastatic colorectal cancer, who have received Elovie® (bevacizumab biosimilar) at participating centers and who meet the eligibility criteria will be invited to participate. In this study, data on the effectiveness and safety of treatment with Elovie, as well as clinical and demographic characteristics and treatment patterns will be collected.
Participants will undergo standard treatment and clinical follow-up as determined by the treating physician.
Data collection will be performed by the researcher and the data transcribed into the Case Report Form data collection form designed specifically for the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Participants of both sexes aged 18 years or older at the start of treatment with bevacizumab;
- •Participants diagnosed with metastatic colorectal cancer, clinical stage IV, unresectable, by clinical definition in medical records, according to the investigator's assessment at the initial consultation and before any type of palliative treatment;
- •Participants who are undergoing first-line treatment with Elovie and who have completed at least 1 cycle of treatment or participants who have started first-line treatment with another bevacizumab (reference or another biosimilar other than Elovie) but who have currently switched to Elovie and completed at least 1 cycle of treatment with it, and whose data is available at the institution participating in the study;
- •Participants with the capacity to understand and consent to their participation in the study through the Free and Informed Consent Form
排除标准
- •Participants who use or have used bevacizumab in a manner different from that described in the current version of the Elovie® package insert;
- •Participants who have been treated with Elovie for a period longer than 12 treatment cycles;
- •Participants who have started first-line treatment with another bevacizumab (reference or another biosimilar other than Elovie) and have completed more than 2 treatment cycles with it;
- •Participants with a concomitant diagnosis of another active malignant neoplasm other than metastatic colorectal cancer.
结局指标
主要结局
Evaluate the effectiveness of treatment with bevacizumab
时间窗: 24 months
Median duration in months and number of cycles of first-line treatment until the switch to second-line treatment, for any reason, through the collection of electronic medical record data.
次要结局
- progression-free survival(24 months)
- Overall survival(24 months)
- The survival rate(24 months)
- Objective Response Rate(24 months)
- Functional capacity(24 months)
- Safety assessment(24 months)