Clinical trial · Interventional
A Study to Evaluate the Efficacy and Safety of SHR-2004 Injection in Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery
A Multicenter, Randomized, Open-label, Active-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-2004 Injection in Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery
NCT06220123CI-TRIAL-00092449completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to evaluate the efficacy and safety of SHR-2004 injection in preventing postoperative venous thromboembolism in patients undergoing ovarian cancer surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enoxaparin Sodium Injection; Rivaroxaban Tablets | Drug | — | UNRESOLVED |
| SHR-2004 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Investigational product arm
- interventionNames
- Drug: SHR-2004
- type
- ACTIVE_COMPARATOR
- label
- Positive control arm
- interventionNames
- Drug: Enoxaparin Sodium Injection; Rivaroxaban Tablets
Primary outcomes (2)
- measure
- Primary efficacy endpoint: The incidence rate of VTE from the first medication to the end of the treatment period (Day 28)
- timeFrame
- up to Day 28
- description
- including asymptomatic deep vein thrombosis (DVT) (confirmed by bilateral lower limb venous compression ultrasound), objectively confirmed symptomatic DVT, and objectively confirmed non-fatal. The composite endpoint of pulmonary thromboembolism (PE) and VTE-related death.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged ≥ 18 years old on the day of signing the informed consent form; 2. Diagnosed as stage III-IV or recurrent ovarian cancer; 3. Have surgical indications and no contraindications to surgery, and voluntarily undergo laparotomy or laparoscopic surgery to treat ovarian cancer; 4. Understand the research procedures and methods, voluntarily participate in this trial, and sign the written informed consent form. Exclusion Criteria: 1. The primary site of the tumor is not the ovary or there is brain metastasis; 2. A history that may increase the risk of bleeding; 3. A history of VTE in the past or during screening, or a disease that increases thrombosis tendency such as protein C deficiency; 4. Patients with atrial fibrillation requiring anticoagulant treatment or the use of artificial heart valves during screening; 5. Acute coronary syndrome within 3 months; 6. Poorly controlled hypertension before screening, and uncontrolled hypertension within 6 months severe cardiac arrhythmia; 7. Any laboratory test indicator during screening or baseline does not meet the standards in the exclusion criteria; 8. Have had a history of adverse reactions or allergies related to rivaroxaban or enoxaparin, such as heparin-induced thrombocytopenia; 9. Have used any drugs prohibited other than investigational drugs within 7 days before screening or plan to use during the study; 10. Those who have participated in any drug intervention clinical trial within 1 month before screening, or those who are within 5 half-lives of the investigational drug at the time of screening, Whichever is longer; 11. Those who are expected to use postoperative neuraxial analgesia; 12. Those who are expected to use plantar vein pumps, intermittent pneumatic compression devices, electronic or mechanical muscle stimulators after surgery; 13. Other circumstances in which the researcher believes that the subject is not suitable to participate in this trial.
References
Publications (1)
- DERIVEDJiang G, Tang J, Zhao H, Zhang K, Gao J, Yang B, Wang L, Yang H, Chen L, An R, Zhang H, Bu H, Tang J, Xu X, Ruan X, Xia B, Wang K, Wei L, Sheng X, Guo Z, Chen L, Wang W, Li J, Wang D, Zhan P, Guo Y, Wang Y, Dong Y, Zhu J. SHR-2004, a Humanized Monoclonal Antibody Targeting Factor XI, for Preventing Venous Thromboembolism After Ovarian Cancer Surgery: A Randomized, Active-Controlled Phase 2 Study. Am J Hematol. 2026 Aug 26. doi: 10.1002/ajh.70481. Online ahead of print. PMID 42644221