A Study to Evaluate the Efficacy and Safety of SHR-2004 Injection in Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery

NCT ID: NCT06220123

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-16
• Study Completion Date: 2024-12-31

Brief Summary

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

Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Investigational product arm

Group Type: EXPERIMENTAL

SHR-2004

Intervention Type: DRUG

Investigational product arm: SHR-2004

Positive control arm

Group Type: ACTIVE_COMPARATOR

Enoxaparin Sodium Injection; Rivaroxaban Tablets

Intervention Type: DRUG

Positive control arm: Enoxaparin Sodium Injection + Rivaroxaban Tablets

Interventions

SHR-2004

Investigational product arm: SHR-2004

Intervention Type: DRUG

Enoxaparin Sodium Injection; Rivaroxaban Tablets

Positive control arm: Enoxaparin Sodium Injection + Rivaroxaban Tablets

Intervention Type: DRUG

Eligibility Criteria

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;

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing Suncadia Pharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

SHR-2004-202

Identifier Type: -

Identifier Source: org_study_id