Clinical trial NCT06220123: A Study to Evaluate the Efficacy and Safety of SHR-2004 Injection in Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery
Lead sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-23
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomized and paralleled 2 arms: Investigational product arm， Positive control arm
Primary purpose: PREVENTION

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 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.

Primary outcomes:
measure: Primary efficacy endpoint: The incidence rate of VTE from the first medication to the end of the treatment period (Day 28)
timeFrame: up to Day 28
measure: 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
timeFrame: up to Day 28
Secondary outcomes:
measure: The event rate of each component of the primary efficacy endpoint
timeFrame: up to Day 28
measure: 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
timeFrame: up to Day 85
measure: The event rate of each component of the primary safety endpoint
timeFrame: up to Day 28
measure: The incidence of any bleeding events (including minor bleeding events) from the first dose to the end of the treatment period
timeFrame: up to Day 28
measure: 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
timeFrame: up to Day 85
measure: The incidence of any bleeding events (including minor bleeding events) from the first dose to the end of follow-up
timeFrame: up to Day 85
measure: The incidence and severity of adverse events.
timeFrame: up to Day 85
Other outcomes:
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