Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery
Conditions
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.
Interventions
DRUGSHR-2004
Investigational product arm: SHR-2004
DRUGEnoxaparin Sodium Injection; Rivaroxaban Tablets
Positive control arm: Enoxaparin Sodium Injection + Rivaroxaban Tablets
Sponsors
Beijing Suncadia Pharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
1:1 randomized and paralleled 2 arms: Investigational product arm， Positive control arm
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 event rate of each component of the primary safety endpoint | 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 |
| 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 |
| The event rate of each component of the primary efficacy endpoint | up to Day 28 | Secondary efficacy endpoint |
Countries
China
Outcome results
None listed