NCT06808685Recruiting
Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie
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
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 133 (estimated)
- First submitted
- 24 Jan 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Libbs Farmacêutica LTDA
- Diseases
- Colorectal cancer
- NCT number
- NCT06808685
What you commit to
- Study type: Observational
- Planned participants: 133
- From 1 Jun 2025 to the primary completion date, 30 Nov 2027
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Vera Cruz Coordinator of this site? Confirm its status | Campinas | Brazil | Recruiting |
| Centro de Oncologia do Paraná (COP) Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| OncoJaraguá Coordinator of this site? Confirm its status | Jaraguá do Sul | Brazil | Recruiting |
| Centro de Pesquisa Unimed Londrina Coordinator of this site? Confirm its status | Londrina | Brazil | Recruiting |
| Associacao Hospitalar Moinhos de Vento Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Centro de Pesquisa Unimed Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Instituto Dor de Pesquisa E Ensino Coordinator of this site? Confirm its status | Recife | Brazil | Recruiting |
| Unidade de Ensino e Pesquisa UEP-COHM Coordinator of this site? Confirm its status | Santo Ângelo | Brazil | Recruiting |
| CEON Pesquisas Coordinator of this site? Confirm its status | São Caetano do Sul | Brazil | Recruiting |
| COE Ensino e Pesquisa Coordinator of this site? Confirm its status | São José dos Campos | Brazil | Recruiting |
| Instituto Dor de Pesquisa E Ensino Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Centro Paulista de Oncologia Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Centro de Ensino e Pesquisa - Hospital São Marcos Coordinator of this site? Confirm its status | Teresina | Brazil | Recruiting |
| Unimed Vitória Coordinator of this site? Confirm its status | Vitória | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.