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临床试验/NCT05009017
NCT05009017Unknown不适用

The Safety Study of Bevacizumab Biosimilars in the Real World

Cancer Institute and Hospital, Chinese Academy of Medical Sciences2 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
272
试验地点
2
主要终点
Adverse drug reactions

研究概览

简要总结

Monoclonal antibody drugs are expensive, and the listing of biosimilar drugs can help increase the availability and lower prices of biologic drugs, and can better meet the public's demand for biotherapeutic products. The first bevacizumab biosimilar in China was launched in December 2019. Although monoclonal antibody biosimilar drugs are similar to the original drug in terms of quality, safety and effectiveness, their production process may be different from the original drug, and their clinical application cannot be completely equivalent to the original drug. Especially after the market is applied to a wider patient population, the safety and effectiveness are more worthy of attention. This study started from the perspective of pharmacy. Three hospitals in China participated in the real-world safety assessment of bevacizumab biosimilars. An observational cohort study design was adopted to include all cases of lung cancer and colorectal cancer using bevacizumab biosimilars and original drugs during the study period, and the propensity score matching was used to reduce the influence of confounding factors and conduct safety assessment.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ①Inpatients diagnosed with non-small cell lung cancer or colorectal cancer; ②Bevacizumab biosimilars or original drugs were used for treatment during the study period.

排除标准

  • ①Age<18 years old; ②Person who has used bevacizumab within six months.

研究组 & 干预措施

Biosimilar group

干预措施: Bevacizumab (Drug)

Originator group

干预措施: Bevacizumab (Drug)

结局指标

主要结局

Adverse drug reactions

时间窗: 12 months

Severity of adverse drug reactions

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guohui Li

Pharmacy

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

研究点 (2)

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