医学
奥沙利铂
伊立替康
福克斯
贝伐单抗
内科学
临床终点
肿瘤科
结直肠癌
养生
肝动脉灌注
临床研究阶段
无进展生存期
随机对照试验
胃肠病学
化疗
癌症
作者
Simon Pernot,Olivier Pellerin,Laurent Mineur,Carole Montérymard,Denis Smith,Bruno Lapuyade,Claire Gallois,F. Khemissa Akouz,Thierry De Baère,David Tougeron,Anne Thirot‐Bidault,Franck Audemar,M. Simon,Cédric Lecaille,Sami Louafi,Côme Lepage,Michel Ducreux,Julien Taı̈eb
标识
DOI:10.1016/j.dld.2021.12.012
摘要
In patients with unresectable liver metastases from colorectal cancer (CRCLM), systemic doublet or triplet chemotherapy and targeted therapy is considered a standard first-line treatment. Hepatic arterial infusion of oxaliplatin (HAI-ox) generates a high response rate, but this still needs to be confirmed in a randomized trial. We incorporated HAI-ox in doublet or triplet + targeted therapy to validate its efficacy.The OSCAR study is an ongoing randomized phase III trial comparing FOLFOX + targeted therapy according to RAS status, or FOLFOXIRI + bevacizumab in patients eligible for triplet therapy, with the same regimen but with HAI-ox instead of IV-ox as the first-line treatment for CRCLM.Main eligibility criteria are colorectal cancer, unresectable liver metastasis, no extra-hepatic metastases except pulmonary nodules if ≤3 and <10 mm, ECOG performance status 0 or 1.The primary endpoint is progression-free survival (PFS). A difference of 4 months for the median PFS in favor of HAI-ox is expected (HR = 0.73). Secondary endpoints include overall survival, overall response rate, secondary liver resection, safety, and quality of life.This study is planned to include 348 patients to demonstrate the superiority of HAI-ox over systemic oxaliplatin in first-line CRCLM treatment (NCT02885753).
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