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

Phase 2

Not yet recruiting

• Conditions: Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery
• Interventions: Drug: SHR-2004; Drug: Enoxaparin Sodium Injection; Rivaroxaban Tablets

• Registration Number: NCT06220123
• Lead Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23
• Study Start: 2024-01-31
• Primary Completion: 2025-06-04
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 350

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 prohibitedother 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational product arm	SHR-2004	-
Positive control arm	Enoxaparin Sodium Injection; Rivaroxaban Tablets	-

Primary Outcome Measures

Name	Time	Method
Primary efficacy endpoint: The incidence rate of VTE from the first medication to the end of the treatment period (Day 28)	up to 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.
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	up to Day 28	Primary safety endpoints

Secondary Outcome Measures

Name	Time	Method
The event rate of each component of the primary efficacy endpoint	up to Day 28	Secondary efficacy endpoint
The event rate of each component of the primary safety endpoint	up to Day 28	Secondary safety endpoints
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	Secondary safety endpoints
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	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.
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	Secondary safety endpoints
The incidence of any bleeding events (including minor bleeding events) from the first dose to the end of follow-up	up to Day 85	Secondary safety endpoints
The incidence and severity of adverse events.	up to Day 85	Secondary safety endpoints