Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of SHR-2004 Injection in Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery
Lead Sponsor:
Beijing Suncadia Pharmaceuticals Co., Ltd
Conditions:
Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Any laboratory test indicator during screening or baseline does not meet the standards in the exclusion criteria;
- 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.
Key Trial Info
Start Date :
February 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT06220123
Start Date
February 16 2024
End Date
December 31 2024
Last Update
July 22 2025
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022