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

NCT06220123 | Completed Phase 2

• 1 other identifier: SHR-2004-202
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• The event rate of each component of the primary 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

  up to Day 85

• The event rate of each component of the primary safety endpoint

  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

  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

  up to Day 85

Study Arms (2)

Investigational product arm

EXPERIMENTAL

Drug: SHR-2004

Positive control arm

ACTIVE COMPARATOR

Drug: Enoxaparin Sodium Injection; Rivaroxaban Tablets

Interventions

SHR-2004 DRUG

Investigational product arm: SHR-2004

Investigational product arm

Enoxaparin Sodium Injection; Rivaroxaban Tablets DRUG

Positive control arm: Enoxaparin Sodium Injection + Rivaroxaban Tablets

Positive control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 years old on the day of signing the informed consent form;
• Diagnosed as stage III-IV or recurrent ovarian cancer;
• Have surgical indications and no contraindications to surgery, and voluntarily undergo laparotomy or laparoscopic surgery to treat ovarian cancer;
• Understand the research procedures and methods, voluntarily participate in this trial, and sign the written informed consent form.

You may not qualify if:

• The primary site of the tumor is not the ovary or there is brain metastasis;
• A history that may increase the risk of bleeding;
• A history of VTE in the past or during screening, or a disease that increases thrombosis tendency such as protein C deficiency;
• Patients with atrial fibrillation requiring anticoagulant treatment or the use of artificial heart valves during screening;
• Acute coronary syndrome within 3 months;
• Poorly controlled hypertension before screening, and uncontrolled hypertension within 6 months severe cardiac arrhythmia;
• Have had a history of adverse reactions or allergies related to rivaroxaban or enoxaparin, such as heparin-induced thrombocytopenia;
• Have used any drugs prohibited other than investigational drugs within 7 days before screening or plan to use during the study;
• 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;
• Those who are expected to use postoperative neuraxial analgesia;
• Those who are expected to use plantar vein pumps, intermittent pneumatic compression devices, electronic or mechanical muscle stimulators after surgery;
• Other circumstances in which the researcher believes that the subject is not suitable to participate in this trial.

Sponsors & Collaborators

• Beijing Suncadia Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Interventions

enoxaparin sodium; Rivaroxaban

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 randomized and paralleled 2 arms: Investigational product arm， Positive control arm

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: February 16, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

CN (1)