Metastatic Colorectal Cancer Clinical Trial
Official title:
A Single-arm Phase II Study of Circulating Soluble Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) as Predictor of Benefit From Bevacizumab (Bev) Beyond Progression in Metastatic Colorectal Cancer (mCRC) - the CIRCUS Study
A growing amount of reports has consistently evidenced that a sustained inhibition of the
angiogenesis is an effective therapeutic strategy, able to improve the outcome of metastatic
colorectal cancer (mCRC) patients.
In the last decade different biologic agents targeting angiogenesis have been approved for
the treatment of mCRC, such as bevacizumab, aflibercept and regorafenib, and, more recently,
solid evidences have demonstrated the efficacy of a sustained antiangiogenic approach even
beyond the first progression to a bevacizumab-containing regimen. In particular, two phase
III randomized trials proved the effectiveness of prosecuting bevacizumab in second-line
switching the chemotherapeutic regimen in patients already treated with bevacizumab in
first-line. Preliminary experiences evidenced that circulating levels of angiogenesis-related
markers are significantly modulated during first-line chemotherapy plus bevacizumab. In
particular, a wide variability of plasma soluble Vascular Endothelial Growth Factor
Receptor-2 (VEGFR-2) levels is observed at the time of disease progression and retrospective
data suggest that benefit from the continuation of bevacizumab may be restricted to patients
with high levels of soluble VEGFR-2 at the first evidence of disease progression. This study
aims at prospectively validating those retrospective data.
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