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Completed

NCT Number: NCT06220123

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

SHR-2004

Drug

Investigational product arm: SHR-2004

Enoxaparin Sodium Injection; Rivaroxaban Tablets

Drug

Positive control arm: Enoxaparin Sodium Injection + Rivaroxaban Tablets

Primary outcomes

  1. Primary efficacy endpoint: The incidence rate of VTE from the first medication to the end of the treatment period (Day 28)

    Time frame: 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.

  2. 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

    Time frame: up to Day 28

    Primary safety endpoints

Secondary outcomes

  1. The event rate of each component of the primary efficacy endpoint

    Time frame: up to Day 28

    Secondary efficacy endpoint

  2. 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

    Time frame: 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.

  3. The event rate of each component of the primary safety endpoint

    Time frame: up to Day 28

    Secondary safety endpoints

  4. The incidence of any bleeding events (including minor bleeding events) from the first dose to the end of the treatment period

    Time frame: up to Day 28

    Secondary safety endpoints

  5. 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

    Time frame: up to Day 85

    Secondary safety endpoints

  6. The incidence of any bleeding events (including minor bleeding events) from the first dose to the end of follow-up

    Time frame: up to Day 85

    Secondary safety endpoints

  7. The incidence and severity of adverse events.

    Time frame: up to Day 85

    Secondary safety endpoints

Sponsors and collaborators

Lead sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2024
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.