Phase I/II study of trifluridine/tipiracil plus XB2001 versus trifluridine/tipiracil in metastatic colorectal cancer.

IF 3 4区医学 Q2 ONCOLOGY Future oncology Pub Date : 2024-11-12 DOI:10.1080/14796694.2024.2415280

Jean-David Fumet, Nicolas Roussot, Aurélie Bertaut, Emeric Limagne, Marion Thibaudin, Alice Hervieu, Sylvie Zanetta, Christophe Borg, Hélène Senellart, Simon Pernot, Frédéric Thuillier, Aurélien Carnot, Laurent Mineur, Benoist Chibaudel, Yann Touchefeu, Jérome Martin-Babau, Marine Jary, Jean-Luc Labourey, Emilie Rederstorff, Come Lepage, Francois Ghiringhelli

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引用次数: 0

Abstract

Aim: Trifluridine/tipiracil-bevacizumab is a standard of care in metastatic colorectal cancer (mCRC) after chemotherapy failure. We aim to assess the addition of XB2001 (anti-IL-1 alpha monoclonal antibody) plus trifluridine/tipiracil-bevacizumab in mCRC refractory to standard chemotherapy.Methods: This multicenter, randomized, double blind, non-comparative Phase I-II study (ClinicalTrials.gov NCT05201352) will assess the efficacy and safety of trifluridine/tipiracil-bevacizumab and XB2001 in patients with mCRC previously treated for metastatic disease by chemotherapy treatment including oxaliplatin, irinotecan, 5-FU, antiangiogenic and/or anti-EGFR if indicated. Primary end point of Phase I is the safety according to the Maximum Tolerated Dose (MTD) of XB2001. Primary end point of Phase II is the efficacy of trifluridine/tipiracil-bevacizumab + XB2001 in term of 6-month overall survival. Ancillary analysis will be performed.

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转移性结直肠癌中三氟啶/替比拉嘧啶加 XB2001 与三氟啶/替比拉嘧啶的 I/II 期研究。

目的：三氟脲啶/替比西嘧啶-贝伐单抗是化疗失败后治疗转移性结直肠癌（mCRC）的标准疗法。我们旨在评估在标准化疗难治的 mCRC 中加用 XB2001（抗 IL-1 alpha 单克隆抗体）加曲氟啶/替比西嘧啶-贝伐单抗的效果：这项多中心、随机、双盲、非比较性I-II期研究（ClinicalTrials.gov NCT05201352）将评估三氟啶/替比西嘧啶-贝伐单抗和XB2001在既往接受过化疗（包括奥沙利铂、伊立替康、5-FU、抗血管生成素和/或抗EGFR（如适用））治疗的mCRC转移性疾病患者中的疗效和安全性。I期研究的主要终点是根据XB2001的最大耐受剂量（MTD）确定的安全性。II期的主要终点是三氟啶/替比西嘧啶-贝伐单抗+XB2001在6个月总生存期方面的疗效。还将进行辅助分析。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Future oncology ONCOLOGY-

CiteScore

5.40

自引率

3.00%

发文量

335

审稿时长

4-8 weeks

期刊介绍： Future Oncology (ISSN 1479-6694) provides a forum for a new era of cancer care. The journal focuses on the most important advances and highlights their relevance in the clinical setting. Furthermore, Future Oncology delivers essential information in concise, at-a-glance article formats - vital in delivering information to an increasingly time-constrained community. The journal takes a forward-looking stance toward the scientific and clinical issues, together with the economic and policy issues that confront us in this new era of cancer care. The journal includes literature awareness such as the latest developments in radiotherapy and immunotherapy, concise commentary and analysis, and full review articles all of which provide key findings, translational to the clinical setting.