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作者

Miao-Zhen Qiu Yuxian Bai Jufeng Wang Kangsheng Gu Mudan Yang Yifu He Cheng Yi Yongdong Jin Bo Liu Feng Wang Yu-kun Chen Wei Dai Yingyi Jiang Chuanpei Huang Rui-Hua Xu Hui-Yan Luo

作者单位

Gastroenterology Ward Department of Medical Oncology，The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital， Zhengzhou ，Shanxi Provincial Cancer Hospital， Taiyuan Oncology Ward 1，The First Affiliated Hospital of Anhui Medical University， Hefei Medical Oncology Ward 1，Anhui Provincial Cancer Hospital， Hefei Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer，Chinese Academy of Medical Sciences， Guangzhou ¹¹Oncology Department 1，The First Affiliated Hospital of Zhengzhou University， Zhengzhou Department of Gastroenterology 1，Harbin Medical University Cancer Hospital， Harbin Abdominal Oncology，West China Hospital of Sichuan University， Chengdu ¹⁰Gastroenterology Ward 3，Cancer Hospital Affiliated to Shandong First Medical University， Ji'nan Department of Medical Oncology，Sichuan Cancer Hospital & Institute，Sichuan Cancer Center，School of Medicine，University of Electronic Science & Technology of China， Chengdu ¹²Clinical Research & Development，Jiangsu Hengrui Pharmaceuticals Co，Ltd， Shanghai Department of Medical Oncology，Sun Yat-sen University Cancer Center， State Key Laboratory of Oncology in South China；Guangdong Provincial Clinical Research Center for Cancer， Guangzhou

刊名

Signal Transduction and Targeted Therapy

年份

2025

卷号

第10卷

期号

第1期

页码

340-349

分类号

R73

摘要

This phase 2/3 trial assessed the efficacy and safety of SHR-1701, a bifunctional protein targeting PD-L1 and TGF-β, in combination with BP102 and XELOX as a first-line treatment for unresectable metastatic colorectal cancer . In this phase 2 study, a total of 62 patients with untreated, histologically confirmed colorectal adenocarcinoma and no prior systemic therapy for metastatic disease were enrolled. Patients received SHR-1701 , bevacizumab , and oxaliplatin intravenously on day 1, along...更多

This phase 2/3 trial assessed the efficacy and safety of SHR-1701, a bifunctional protein targeting PD-L1 and TGF-β, in combination with BP102 and XELOX as a first-line treatment for unresectable metastatic colorectal cancer . In this phase 2 study, a total of 62 patients with untreated, histologically confirmed colorectal adenocarcinoma and no prior systemic therapy for metastatic disease were enrolled. Patients received SHR-1701 , bevacizumab , and oxaliplatin intravenously on day 1, along with oral capecitabine on days 1-14 of 21-day cycles. Up to eight induction cycles were administered, followed by maintenance therapy for responders or those with stable disease. The primary endpoints were safety and objective response rate per RECIST v1.1. The combination achieved an ORR of 59.7% and a disease control rate of 83.9%. Median progression-free survival was 10.3 months , with 6- and 12-month PFS rates of 77.2% and 41.3%, respectively. The estimated 12-month overall survival rate was 67.7%. Grade ≥3 treatment-related adverse events were reported in 59.7% of patients, with anemia and neutropenia being the most common. Retrospective DNA sequencing revealed that high tumor mutational burden, neo-antigens, and SBS15 enrichment correlated with better responses. Elevated baseline lactate dehydrogenase was linked to shorter PFS. SHR-1701 combined with XELOX and bevacizumab demonstrated a manageable safety profile and potent antitumor activity in unresectable mCRC.收起

基金

国家自然科学基金;广东省自然科学基金

文献类型

期刊