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Cheaper cancer drug alternative under Real-World scrutiny

NCT ID NCT06808685

Disease control Sponsor: Libbs Farmacêutica LTDA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking how well a biosimilar drug called Elovie (a copy of bevacizumab) works for people with advanced colorectal cancer that cannot be removed by surgery. Researchers will follow 133 patients in Brazil who are receiving Elovie as their first treatment, measuring how long they stay on the drug before needing a switch and how long they live. The goal is to see if this more affordable option performs as expected in real-world hospital settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bevacizumab biosimilar (Elovie)
What this could lead to
If successful, this study could confirm that Elovie works as well as the original bevacizumab for treating metastatic colorectal cancer in everyday clinical practice.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. It is also limited to the Brazilian population, so findings may not apply elsewhere.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 133 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult participants of both sexes 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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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, 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 Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic colorectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Associação Hospitalar Moinhos de Vento

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90560-032, Brazil

  • CEON+ Pesquisas

    RECRUITING

    São Caetano do Sul, São Paulo, 09541-270, Brazil

  • COE Ensino e Pesquisa

    RECRUITING

    São José dos Campos, São Paulo, 12243-580, Brazil

  • Centro Paulista de Oncologia

    RECRUITING

    São Paulo, São Paulo, 04.538-135, Brazil

  • Centro de Ensino e Pesquisa - Hospital São Marcos

    RECRUITING

    Teresina, Piauí, 64002-595, Brazil

  • Centro de Oncologia do Paraná (COP)

    RECRUITING

    Curitiba, Paraná, 82305-100, Brazil

  • Centro de Pesquisa Unimed Londrina

    RECRUITING

    Londrina, Paraná, 86050-460, Brazil

  • Centro de Pesquisa Unimed Porto Alegre

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90560-003, Brazil

  • Hospital Vera Cruz

    RECRUITING

    Campinas, São Paulo, 13092-108, Brazil

  • Instituto Dor de Pesquisa E Ensino

    RECRUITING

    Recife, Pernambuco, 50070-480, Brazil

  • Instituto Dor de Pesquisa E Ensino

    RECRUITING

    São Paulo, São Paulo, Brazil

  • OncoJaraguá

    RECRUITING

    Jaraguá do Sul, Santa Catarina, 89253-080, Brazil

  • Unidade de Ensino e Pesquisa UEP-COHM

    RECRUITING

    Santo Ângelo, Rio Grande do Sul, 98.801.706, Brazil

  • Unimed Vitória

    RECRUITING

    Vitória, Espírito Santo, 29047660, Brazil

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