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

Beijing Suncadia Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery

Treatments: Drug: SHR-2004; Drug: Enoxaparin Sodium Injection; Rivaroxaban Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06220123

SHR-2004-202

Details and patient eligibility

About

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.

Enrollment: 225 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 2 patient groups

Investigational product arm

Experimental group

Treatment:

Drug: SHR-2004

Positive control arm

Active Comparator group

Treatment:

Drug: Enoxaparin Sodium Injection; Rivaroxaban Tablets