Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Evaluate the effectiveness of treatment with bevacizumab [Срок оценки: 24 months]

Вторичные конечные точки (6)

• progression-free survival [Срок оценки: 24 months]
• Overall survival [Срок оценки: 24 months]
• The survival rate [Срок оценки: 24 months]
• Objective Response Rate [Срок оценки: 24 months]
• Functional capacity [Срок оценки: 24 months]
• Safety assessment [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Бразилия · 14 центров

• Unimed Vitória — Vitória
• Centro de Oncologia do Paraná (COP) — Curitiba
• Centro de Pesquisa Unimed Londrina — Londrina
• Instituto Dor de Pesquisa E Ensino — Recife
• Centro de Ensino e Pesquisa - Hospital São Marcos — Teresina
• Centro de Pesquisa Unimed Porto Alegre — Porto Alegre
• Associação Hospitalar Moinhos de Vento — Porto Alegre
• Unidade de Ensino e Pesquisa UEP-COHM — Santo Ângelo
• … и ещё 6 центров

Идентификаторы

NCT: NCT06808685 · LB2401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗