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

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.

Study Overview

• Status: Completed
• Conditions: Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery
• Intervention / Treatment: Drug: SHR-2004; Drug: Enoxaparin Sodium Injection; Rivaroxaban Tablets

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational product arm	Drug: SHR-2004; Investigational product arm: SHR-2004
Active Comparator: Positive control arm	Drug: Enoxaparin Sodium Injection; Rivaroxaban Tablets; Positive control arm: Enoxaparin Sodium Injection + Rivaroxaban Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary efficacy endpoint: The incidence rate of VTE from the first medication to the end of the treatment period (Day 28)	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.	up to Day 28
The composite endpoint incidence rate of major bleeding and clinically relevant non-major bleeding events as defined by the International Society on Thrombosis and Haemostasis (ISTH) from the first dose to the end of the treatment period	Primary safety endpoints	up to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The event rate of each component of the primary efficacy endpoint	Secondary efficacy endpoint	up to Day 28
Secondary efficacy endpoint: The total VTE incidence rate from the first medication to the end of follow-up (D85) and the incidence rate of each component event	including asymptomatic DVT (confirmed by bilateral lower limb venous compression color ultrasound), objectively confirmed symptomatic DVT, and objectively confirmed non-fatal. The composite endpoint of sexual PE and VTE-related death.	up to Day 85
The event rate of each component of the primary safety endpoint	Secondary safety endpoints	up to Day 28
The incidence of any bleeding events (including minor bleeding events) from the first dose to the end of the treatment period	Secondary safety endpoints	up to Day 28
The composite endpoint incidence rate and each component event rate of major bleeding and clinically relevant non-major bleeding events that meet the definition of ISTH from the first medication to the end of follow-up	Secondary safety endpoints	up to Day 85
The incidence of any bleeding events (including minor bleeding events) from the first dose to the end of follow-up	Secondary safety endpoints	up to Day 85
The incidence and severity of adverse events.	Secondary safety endpoints	up to Day 85

Collaborators and Investigators

• Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Genital Diseases, Female; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Embolism and Thrombosis; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Carcinoma; Carcinoma, Ovarian Epithelial; Ovarian Neoplasms; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Fibrin Modulating Agents; Fibrinolytic Agents; Anticoagulants; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Rivaroxaban; Enoxaparin sodium; Enoxaparin
• Other Study ID Numbers: SHR-2004-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No