1. Phase II biomarker identification study of anti-VEGF agents with FOLFIRI for pretreated metastatic colorectal cancer.
- Author
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Hashimoto T, Otsu S, Hironaka S, Takashima A, Mizusawa J, Kataoka T, Fukuda H, Tsukamoto S, Hamaguchi T, and Kanemitsu Y
- Subjects
- Humans, Bevacizumab adverse effects, Vascular Endothelial Growth Factor D therapeutic use, Vascular Endothelial Growth Factor A, Oxaliplatin, Camptothecin therapeutic use, Prospective Studies, Fluorouracil adverse effects, Biomarkers, Leucovorin adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Clinical Trials, Phase II as Topic, Colorectal Neoplasms pathology, Colonic Neoplasms drug therapy, Rectal Neoplasms drug therapy
- Abstract
Chemotherapy plus antiangiogenic agents, including bevacizumab, ramucirumab and aflibercept, is a standard second-line treatment for patients with metastatic colorectal cancer, but which specific agents should be selected is ambiguous due to a lack of clear evidence from prospective studies. Previous reports have suggested ramucirumab and aflibercept could be more effective than bevacizumab in patients with high VEGF-D and high VEGF-A, respectively. JCOG2004 is a three-arm, randomized, phase II study to identify predictive biomarkers for these agents in patients who have failed first-line treatment. The study will enroll 345 patients from 52 institutions for 2 years, with progression-free survival in high VEGF-D (bevacizumab vs ramucirumab) and high VEGF-A (bevacizumab vs aflibercept) serving as the primary end point. Clinical Trial Registration: jRCTs031220058 (www.jrct.niph.go.jp).
- Published
- 2023
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