SHR ‐2004, a Humanized Monoclonal Antibody Targeting Factor XI , for Preventing Venous Thromboembolism After Ovarian Cancer Surgery: A Randomized, Active‐Controlled Phase 2 Study

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.

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Journal
American Journal of Hematology
Published
2026-08-26
DOI
https://doi.org/10.1002/ajh.70481
Primary Topic
Coagulation, Bradykinin, Polyphosphates, and Angioedema
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article
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article

SHR ‐2004, a Humanized Monoclonal Antibody Targeting Factor XI , for Preventing Venous Thromboembolism After Ovarian Cancer Surgery: A Randomized, Active‐Controlled Phase 2 Study

Guangyi Jiang, Danbo Wang, Jianqing Zhu, Ke-Qiang Zhang et al.
American Journal of Hematology
Coagulation, Bradykinin, Polyphosphates, and Angioedema
article

SHR ‐2004, a Humanized Monoclonal Antibody Targeting Factor XI , for Preventing Venous Thromboembolism After Ovarian Cancer Surgery: A Randomized, Active‐Controlled Phase 2 Study

Guangyi Jiang, Danbo Wang, Jianqing Zhu, Ke-Qiang Zhang, Xiaohong Ruan, Xizhong Xu, Ping Zhan, Luwei Wei, Jie Tang, Ruifang An, Yuqi Wang, Jin Li, Zhe Guo, Bairong Xia, Junying Tang, Yuhan Guo, Hualei Bu, Hongying Yang, Lihong Chen, Hongwei Zhao, Jun Gao, Bo Yang, Liang Chen, Hui Zhang, Xiujie Sheng, Li Wang, Wei Wang, Yanli Dong, Ke Wang
article en

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.

American Journal of Hematology
Hebei Medical University (CN), Jiangnan University (CN), Bengbu Medical College (CN), Shanxi Medical University (CN), Kunming Medical University (CN), Tianjin Medical University Cancer Institute and Hospital (CN), Affiliated Hospital of Southwest Medical University (CN), Liuzhou Maternal and Child Health Hospital (CN), Shaanxi Provincial People's Hospital (CN), Liuzhou General Hospital (CN), Third Affiliated Hospital of Guangzhou Medical University (CN), Fudan University Shanghai Cancer Center (CN), Jiangxi Provincial Cancer Hospital (CN), Zhejiang Cancer Hospital (CN), Shandong Tumor Hospital (CN), Shanxi Provincial Cancer Hospital (CN), Fourth Hospital of Hebei Medical University (CN), Wuxi Fourth People's Hospital (CN), Nanyang Institute of Technology (CN), Hunan Cancer Hospital (CN), First Affiliated Hospital of Xi'an Jiaotong University (CN), Anhui Provincial Hospital (CN), The Affiliated Yongchuan Hospital of Chongqing Medical University (CN), Second Hospital of Shanxi Medical University (CN), Henan Cancer Hospital (CN), Jiangmen Central Hospital (CN), Jiangsu Hengrui Medicine (China) (CN), First Affiliated Hospital of Bengbu Medical College (CN), Shanxi Provincial People’s Hospital (CN), Liaoning Cancer Hospital & Institute (CN), Qilu Hospital of Shandong University (CN), Shandong First Medical University (CN), Hangzhou Cancer Hospital (CN), Chongqing Medical University (CN), Guangzhou Medical University (CN)
Good health and well-being
Openalex Percentile: Top 11%
Coagulation, Bradykinin, Polyphosphates, and Angioedema
DOIOpen Access PDFOpenAlex
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