Multi-Centre, Observational Study on Safety of Bevacizumab Biosimilars in Clinical Practice Among Chinese Patients

August 12, 2021 updated by: Guohui Li, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

The Safety Study of Bevacizumab Biosimilars in the Real World

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

272

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Not yet recruiting
        • Wenzhou Zhang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inpatients in 3 study hospitals diagnosed with non-small cell lung cancer or colorectal cancer using originator or biosimilar of bevacizumab

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Biosimilar group
Drug: Bevacizumab
Patients with colorectal cancer or lung cancer who use originator or biosimilar of bevacizumab
Originator group
Drug: Bevacizumab
Patients with colorectal cancer or lung cancer who use originator or biosimilar of bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse drug reactions
Time Frame: 12 months
Severity of adverse drug reactions
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

August 12, 2021

First Submitted That Met QC Criteria

August 12, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC2863

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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