Metastatic Colorectal CancerNCT06808685
Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie
An observational study of Metastatic Colorectal Cancer, run by Libbs Farmacêutica LTDA at 14 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- How many people
- 133 participants
- Where
- 14 sitesBrazil
- Study dates
- 1 Jun 2025to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Brazil14 sites, 14 recruiting
- Recruiting
Hospital Vera Cruz
Campinas, São Paulo, 13092-108
André D Sasse, Mr., +55 19 98111-0546, andre.sasse@hospitalveracruz.com.br
- Recruiting
Centro de Oncologia do Paraná (COP)
Curitiba, Paraná, 82305-100
Bruno R Batista, Mr., +55 41 999045149, bruno.ribeiro.batista@hotmail.com
- Recruiting
OncoJaraguá
Jaraguá do Sul, Santa Catarina, 89253-080
Luis C Stoeberl, Mr., +55 47 99979-7380, luis@oncojaragua.com.br
- Recruiting
Centro de Pesquisa Unimed Londrina
Londrina, Paraná, 86050-460
Cristiano Argenti, Mr., +55 43 3375-5235, Argenti18@hotmail.com
- Recruiting
Centro de Pesquisa Unimed Porto Alegre
Porto Alegre, Rio Grande do Sul, 90560-003
Fernanda Longhi, Mrs, +55 51 99707-3256, fernanda.longhi@unimedpoa.com.br
- Recruiting
Associação Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90560-032
Rui F Weschenfelder, Mr., +55 (51) 3314-8258, rui.fernando@hmv.org.br
- Recruiting
Instituto Dor de Pesquisa E Ensino
Recife, Pernambuco, 50070-480
Rafael C Lima, Mr., +81 99527-8051, Rafael_caires84@hotmail.com
- Recruiting
Unidade de Ensino e Pesquisa UEP-COHM
Santo Ângelo, Rio Grande do Sul, 98.801.706
Lourenço M Sangoi, Mr., +55 55 9 9961-6032, lasangoi@gmail.com
- Recruiting
CEON+ Pesquisas
São Caetano do Sul, São Paulo, 09541-270
Daniel Cubero, Mr., +55 11 9 9964-2770, daniel.cubero@ceonmaispesquisas.com.br
- Recruiting
COE Ensino e Pesquisa
São José dos Campos, São Paulo, 12243-580
Fabiano A Costa, Mr., +55 11 96090-3468, fabiano.costa@coe.com.br
- Recruiting
Centro Paulista de Oncologia
São Paulo, São Paulo, 04.538-135
Mauro D Donadio, Mr., +55 (11) 97144-5373, mauro.donadio@medicos.oncoclinicas.com
- Recruiting
Instituto Dor de Pesquisa E Ensino
São Paulo, São Paulo
Camila Motta Moniz, Mrs, +55 11 93701-3011, camila.venchiarutti@idor.org
Camila Motta Moniz, Mrs
- Recruiting
Centro de Ensino e Pesquisa - Hospital São Marcos
Teresina, Piauí, 64002-595
Mariella A Melo, Mrs, +55 (86) 9 9998-1098, mariellaalmeida@gmail.com
- Recruiting
Unimed Vitória
Vitória, Espírito Santo, 29047660
Morgana S Rossi, Mrs, +55 27 99956-5556, morgstelzer@hotmail.com
About this study
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
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.
Read the 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.
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Elovie, bevacizumab, metastatic colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of treatment with bevacizumab
Median duration in months and number of cycles of first-line treatment until the switch to second-line treatment, for any reason, through the collection of electronic medical record data.
Measured: 24 months
Secondary outcomes (6)
progression-free survival
progression-free survival will be defined as the median time (in months) from the first dose of bevacizumab to disease progression
Measured: 24 months
Overall survival
Overall survival will be defined as the median time (in months) from the first dose of bevacizumab until the occurrence of death, from any cause, during the 24-month follow-up period
Measured: 24 months
The survival rate
The survival rate will be defined as the number and proportion of participants who remained alive after 24 months of follow-up
Measured: 24 months
Objective Response Rate
The Objective Response Rate will be defined as the number and percentage of participants who had a Complete Response or Partial Response, using the usual methodology of the research center, during 24 months of follow-up after the start of bevacizumab use. The number and percentage of participants who had Stable Disease or Disease Progression will also be evaluated.
Measured: 24 months
Functional capacity
Functional capacity will be assessed using the ECOG (Eastern cooperative oncology group) scale during 24 months of follow-up after starting bevacizumab.
Scale ECOG Grade 0 - Fully active, able to carry on all pre disease performance without restriction Grade 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Grade 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours Grade 3 - Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours Grade 4 - Completely disabled; cannot carry on any selfcare; totally confined to bed or chair Grade 5 - Dead https://ecog-acrin.org/resources/ecog-performance-status/
Measured: 24 months
Safety assessment
To assess the occurrence of adverse events in the 24-month follow-up period since the first dose of Elovie.Assess the median duration of treatment through time in months and number of cycles until switching to another treatment other than the first line, for reasons of toxicity (adverse event).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Jun 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Libbs Farmacêutica LTDA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808685
- Sponsor's protocol ID
- LB2401
- Status last verified
- Dec 2025
- First submitted
- 24 Jan 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06808685
- Acronym / sponsor ID
- LB2401
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Elovie, bevacizumab, metastatic colorectal cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- Libbs Farmacêutica LTDAIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the effectiveness of treatment with bevacizumab
Time frame: 24 months
Median duration in months and number of cycles of first-line treatment until the switch to second-line treatment, for any reason, through the collection of electronic medical record data.
6 secondary outcomes
progression-free survival
Time frame: 24 months
Overall survival
Time frame: 24 months
The survival rate
Time frame: 24 months
Objective Response Rate
Time frame: 24 months
Functional capacity
Time frame: 24 months
Safety assessment
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Centro de Oncologia do Paraná (COP)
Curitiba, Brazil
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Libbs Farmacêutica LTDA at 14 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of treatment with bevacizumab (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.