A Randomized Phase III Study of Anlotinib Versus Bevacizumab in Combination With CAPEOX as First-Line Therapy for RAS/BRAF Wild-Type Metastatic Colorectal Cancer: A Clinical Trial Protocol

作者：Jinjie He, Yue Liu, Chengcheng Liu, Hanguang Hu, Lifeng Sun, Dong Xu, Jun Li, Junye Wang, Xiaobing Chen, Rongbo Lin, Yi Jiang, Yanqiao Zhang, Weisheng Zhang, Ying Cheng, Xiaohong Wu, Mingzhi Fang, Enxiao Li, Ye Xu, Ye Chen, Jiayi Li, Yanyan Cui, Zhanyu Pan, Songnan Zhang, Ying Yuan, Kefeng Ding · 发表于：Technology in Cancer Research & Treatment · 年份：2023 · DOI：10.1177/15330338231152350 · 被引用次数：20 · 研究领域：Gastric Cancer Management and Outcomes、Colorectal Cancer Treatments and Studies、Colorectal and Anal Carcinomas

Background: Chemotherapy combined with antivascular endothelial growth factor (VEGF) or anti-epidermal growth factor receptor monoclonal antibodies is the most promising approach to prolong survival and improve the quality of life of patients with unresectable metastatic colorectal cancer (mCRC). Anlotinib is an oral antiangiogenic tyrosine kinase inhibitor that targets VEGF receptors 1/2/3, fibroblast growth factor receptors 1-4, and platelet-derived growth factor receptors a/β. Since anlotinib combined with oxaliplatin and capecitabine (CAPEOX) as a first-line treatment was previously shown to be effective and safe for patients with RAS/BRAF wild-type (WT) mCRC, we designed this randomized, open-label, parallel-group, non-inferiority, phase III study to evaluate the efficacy and safety of anlotinib plus CAPEOX versus bevacizumab plus CAPEOX in patients with RAS/BRAF WT mCRC. Methods/design: The primary inclusion criteria are Eastern Cooperative Oncology Group performance status 0/1, confirmed RAS/BRAF WT colorectal adenocarcinoma, and unresectable metastases assessed by a multidisciplinary team. The main exclusion criteria are as follows: high microsatellite instability or deficient mismatch repair status, resectable or potentially resectable metastases, and previous systemic therapy for mCRC. A total of 698 patients will be randomized into the anlotinib and bevacizumab groups in a 1:1 ratio. Patients will receive 4 to 8 cycles of induction therapy (CAPEOX plus anlotinib or...