SHR ‐2004, a Humanized Monoclonal Antibody Targeting Factor XI , for Preventing Venous Thromboembolism After Ovarian Cancer Surgery: A Randomized, Active‐Controlled Phase 2 Study
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: This multicenter, randomized, open-label, exploratory Phase 2 trial assessed SHR-2004, an anti-FXI antibody, for venous thromboembolism (VTE) prevention in patients undergoing ovarian cancer surgery-a population at particularly high thrombotic risk conducted at 25 sites in China. Patients with newly diagnosed Stage III-IV or recurrent ovarian cancer scheduled for surgery were randomly assigned (1:1) to receive subcutaneous SHR-2004 (180 mg on Day 1 and 120 mg on Day 15) or enoxaparin-rivaroxaban (subcutaneous enoxaparin 40 mg once daily during hospitalization, followed by oral rivaroxaban 10 mg once daily after discharge until Day 28). The primary efficacy outcome was the composite of VTE events within 28 days. The primary safety outcome was major bleeding (MB) or clinically relevant nonmajor bleeding (CRNMB) from first dose to 28 days. Between February 19, 2024 and September 17, 2024, 198 patients received assigned treatment (90 with SHR-2004, 108 with enoxaparin-rivaroxaban) and were included in the safety analysis. Among 181 patients who completed protocol-mandated ultrasonography, VTE occurred in 11 (12.6%) patients in the SHR-2004 group and 19 (20.2%) in the enoxaparin-rivaroxaban group (difference -8.4%, 95% CI -19.9 to 3.1) by Day 28. MB/CRNMB rates were similar between groups (SHR-2004: 2/90 [2.2%]; enoxaparin-rivaroxaban: 2/108 [1.9%]). In this study, SHR-2004 showed comparable efficacy to enoxaparin-rivaroxaban for preventing postoperative VTE in patients undergoing ovarian cancer surgery, with a similar low risk of MB or CRNMB. The twice-monthly dosing schedule offers a potential advantage over daily anticoagulation, supporting further investigation in adequately powered Phase 3 trials. Trial Registration: ClinicalTrials.gov identifier: NCT06220123.
Source: American Journal of Hematology
DOI: 10.1002/ajh.70481
Authors: Guangyi Jiang, Jie Tang, Hongwei Zhao, Keqiang Zhang, Jun Gao, Bo Yang, Li Wang, Hongying Yang, Liang Chen, Ruifang An, Hui Zhang, Hualei Bu, Junying Tang, Xizhong Xu, Xiaohong Ruan, Bairong Xia, Ke Wang, Luwei Wei, Xiujie Sheng, Zhe Guo, Lihong Chen, Wei Wang, Jin Li, Danbo Wang, Ping Zhan, Yuhan Guo, Yuqi Wang, Yanli Dong, Jianqing Zhu
Institutions: Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine, Chinese Academy of Sciences, Hunan Cancer Hospital, The Affiliated Yongchuan Hospital of Chongqing Medical University, Shanxi Provincial Cancer Hospital, Jiangxi Provincial Cancer Hospital, First Affiliated Hospital of Bengbu Medical College, Zhengzhou University, Henan Cancer Hospital, Shaanxi Provincial People's Hospital, Shandong Tumor Hospital, First Affiliated Hospital of Xi'an Jiaotong University, First Hospital of Xi'an, Fourth Hospital of Hebei Medical University, Qilu Hospital of Shandong University, Wuxi Fourth People's Hospital, Jiangmen Central Hospital, Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University, Fourth Affiliated Hospital of Guangxi Medical University, Third Affiliated Hospital of Guangzhou Medical University, Shanxi Medical University, Second Hospital of Shanxi Medical University, Fudan University Shanghai Cancer Center, Liaoning Cancer Hospital & Institute, Southwest Medical University, Affiliated Hospital of Southwest Medical University
Language: English
Subfield: Internal Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W7204258695