OMega-3 Fatty Acid for the Immune Modulation of Colorectal Cancer

This is a prospective, double-blind, placebo-controlled, randomized clinical trial to assess the effects of daily 4-gram marine omega-3 polyunsaturated fatty acid (MO3PUFA), through treatment with AMR101 (VASCEPA, icosapent ethyl) on the tumor immune microenvironment and gut microbiome in patients who are diagnosed with colorectal cancer or with a colorectal mass or polyp suspected to be a cancer or advanced adenoma and will undergo surgical resection or interventional endoscopy at the Massachusetts General Hospital (MGH). It uses the novel "window-of-opportunity" clinical trial design to take advantage of the window of time between cancer/mass/polyp diagnosis and surgery to examine the effect of therapeutic agents on tumor pathologic and molecular features unperturbed by prior therapies.

本研究为一项前瞻性、双盲、安慰剂对照的随机临床试验，旨在评估每日4克剂量的海洋ω-3多不饱和脂肪酸（marine omega-3 polyunsaturated fatty acid, MO3PUFA）经AMR101（VASCEPA，二十碳五烯酸乙酯）给药后，对结直肠癌、疑似癌变或晚期腺瘤的结直肠肿物/息肉患者的肿瘤免疫微环境与肠道菌群的影响；上述受试者将在麻省总医院（Massachusetts General Hospital, MGH）接受手术切除或介入内镜诊疗。本研究采用新颖的“机会之窗（window-of-opportunity）”临床试验设计，借助癌症/肿物/息肉确诊至手术前的时间窗口，探究治疗药物对未受前期治疗干扰的肿瘤病理特征与分子特征的影响。