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NCT06220123CompletedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 22 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
225 (actual)
First submitted
12 Jan 2024
Start date
16 Feb 2024
Primary completion date
31 Dec 2024
Lead sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd
NCT number
NCT06220123

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 225
  • From 16 Feb 2024 to the primary completion date, 31 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 plantar vein pumps, intermittent pneumatic compression devices, electronic or mechanical muscle stimulators after surgery;

Other illness

  • 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;
  • Have had a history of adverse reactions or allergies related to rivaroxaban or enoxaparin, such as heparin-induced thrombocytopenia;

Lab values

  • Any laboratory test indicator during screening or baseline does not meet the standards in the exclusion criteria;

Other

  • The primary site of the tumor is not the ovary or there is brain metastasis;
  • Those who are expected to use postoperative neuraxial analgesia;
  • Other circumstances in which the researcher believes that the subject is not suitable to participate in this trial.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhejiang Cancer Hospital
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.