Clinical trial NCT06808685: Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Metastatic Colorectal Cancer
Keywords: Elovie
bevacizumab
Lead sponsor: Libbs Farmacêutica LTDA
Sponsor class: INDUSTRY
First posted: 2025-02-05
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult participants of both sexes diagnosed with unresectable clinical stage IV metastatic colorectal cancer who are being treated with bevacizumab biosimilar Elovie

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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
* Participants with the capacity to understand and consent to their participation in the study through the Free and Informed Consent Form

Exclusion Criteria:

* Participants who are or have used bevacizumab in a manner other than that described in the package insert
* Participants who have been treated with Elovie for a period longer than 6 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 this

Primary outcomes:
measure: Evaluate the effectiveness of treatment with bevacizumab
timeFrame: 24 months
Secondary outcomes:
measure: progression-free survival
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
measure: The survival rate
timeFrame: 24 months
measure: Objective Response Rate
timeFrame: 24 months
measure: Functional capacity
timeFrame: 24 months
measure: Safety assessment
timeFrame: 24 months
Other outcomes:
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Study officials:
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