Phase 1b/2 trial of fruquintinib plus sintilimab in treating advanced solid tumours: The dose-escalation and metastatic colorectal cancer cohort in the dose-expansion phases

被引：37

作者：

Guo, Ye ^{[1
]}

Zhang, Weijie ^{[2
]}

Ying, Jieer ^{[3
]}

Zhang, Yanqiao ^{[4
]}

Pan, Yueyin ^{[5
]}

Qiu, Wensheng ^{[6
]}

Fan, Qingxia ^{[2
]}

Xu, Qi ^{[3
]}

Ma, Yue ^{[4
]}

Wang, Gang ^{[5
]}

Guo, Jing ^{[6
]}

Su, Weiguo ^{[7
]}

Fan, Songhua ^{[7
]}

Tan, Panfeng ^{[7
]}

Wang, Yan ^{[8
]}

Luo, Yang ^{[8
]}

Zhou, Hui ^{[8
]}

Li, Jin ^{[1
,9
]}

机构：

[1] Tongji Univ, Shanghai East Hosp, Sch Med, Shanghai, Peoples R China

[2] Zhengzhou Univ, Affiliated Hosp 1, Zhengzhou, Peoples R China

[3] Zhejiang Canc Hosp, Hangzhou, Peoples R China

[4] Harbin Med Univ, Canc Hosp, Harbin, Peoples R China

[5] Anhui Prov Hosp, Hefei, Peoples R China

[6] Affiliated Hosp Qingdao Univ, Qingdao, Peoples R China

[7] HUTCHMED Ltd, Shanghai, Peoples R China

[8] Innovent Biol Inc, Suzhou, Peoples R China

[9] Tongji Univ, Shanghai East Hosp, Sch Med, Dept oncol, Shanghai, Peoples R China

来源：

EUROPEAN JOURNAL OF CANCER | 2023年 / 181卷

关键词：

Fruquintinib; Sintilimab; Advanced solid tumors; Metastatic colorectal cancer; OPEN-LABEL; REGORAFENIB; COMBINATION; BEVACIZUMAB; NIVOLUMAB; PLACEBO;

D O I：

10.1016/j.ejca.2022.12.004

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: Fruquintinib (anti-vascular endothelial growth factor 1/2/3) plus sin-tilimab (anti-programmed death-1) demonstrated enhanced anti-tumour effects versus mono -therapy in a preclinical study. We investigated the combination in patients with advanced solid tumours, including metastatic colorectal cancer (mCRC). Methods: In this phase 1b/2, open-label, multi-centre, multi-cohort dose-escalation and dose -expansion study, patients with advanced solid tumours (dose-escalation) or mCRC (one cohort in dose-expansion) received different doses of fruquintinib plus a fixed dose of sintili-mab once every 4 weeks (Q4W) or 3 weeks (Q3W). Primary objectives were safety, tolerability, and the preliminary efficacy. This study is registered at ClinicalTrials.gov, NCT03903705.Findings: By the data cut-off date (30th December 2021), 23 patients were enrolled in the dose -escalation and 37 patients in the mCRC cohort of the dose-expansion; 44 patients with mCRC

引用

页码：26 / 37

页数：12

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