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

NCT05009017 | Unknown

• 1 other identifier: NCC2863
• Study Type: observational
• Target: 272
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Biosimilar

Outcome Measures

Primary Outcomes (1)

• Adverse drug reactions

  Severity of adverse drug reactions

  12 months

Study Arms (2)

Biosimilar group

Drug: Bevacizumab

Originator group

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

Patients with colorectal cancer or lung cancer who use originator or biosimilar of bevacizumab

Biosimilar group; Originator group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (2)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Wenzhou Zhang

Zhengzhou, Henan, 450008, China

NOT YET RECRUITING

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Guohui Li, Bachelor

CONTACT

01087788578; lgh0603@cicams.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacy

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 17, 2021
• Study Start: January 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

CN (2)