Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer SurgeryPhase 2NCT06220123

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

A Phase 2 study testing SHR-2004 and Enoxaparin Sodium Injection; Rivaroxaban Tablets in people with Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery
What is being tested?: SHR-2004 and Enoxaparin Sodium Injection; Rivaroxaban Tablets
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 225 participants
Where: 1 siteChina
Study dates: 16 Feb 2024to 31 Dec 2024
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022

Other trials in China

About this study

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

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.

Conditions: Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery
Being tested: SHR-2004, Enoxaparin Sodium Injection; Rivaroxaban Tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SHR-2004Drug
Investigational product arm: SHR-2004
Enoxaparin Sodium Injection; Rivaroxaban TabletsDrug
Positive control arm: Enoxaparin Sodium Injection + Rivaroxaban Tablets

Study groups in NCT06220123
Study group	Role	What they receive
Investigational product arm	Experimental	Not described Receives: Drug: SHR-2004
Positive control arm	Active comparator	Not described Receives: Drug: Enoxaparin Sodium Injection; Rivaroxaban Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary efficacy endpoint: The incidence rate of VTE from the first medication to the end of the treatment period (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.
Measured: up to Day 28
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
Primary safety endpoints
Measured: up to Day 28

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Feb 202431 Dec 2024

First posted23 Jan 2024
Study start16 Feb 2024
Primary completion31 Dec 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer SurgeryStudies of the same condition, open and under way.
More trials run by Beijing Suncadia Pharmaceuticals Co., LtdThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: 1:1 randomized and paralleled 2 arms: Investigational product arm， Positive control arm
Masking: None (open label)
Enrolment: 225 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06220123
Sponsor's protocol ID: SHR-2004-202
Status last verified: Jul 2025
First submitted: 12 Jan 2024
Last updated: 22 Jul 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Jiang G, Tang J, Zhao H, Zhang K, Gao J, Yang B, Wang L, Yang H, Chen L, An R, Zhang H, Bu H, Tang J, Xu X, Ruan X, Xia B, Wang K, Wei L, Sheng X, Guo Z, Chen L, Wang W, Li J, Wang D, Zhan P, Guo Y, Wang Y, Dong Y, Zhu J. SHR-2004, a Humanized Monoclonal Antibody Targeting Factor XI, for Preventing Venous Thromboembolism After Ovarian Cancer Surgery: A Randomized, Active-Controlled Phase 2 Study. Am J Hematol. 2026 Aug 26. doi: 10.1002/ajh.70481. Online ahead of print.
PubMed 42644221

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06220123
Acronym / sponsor ID: SHR-2004-202
Conditions: Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 225 participants (actual)
Lead sponsor: Beijing Suncadia Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
Study start: 16 Feb 2024 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 23 Jan 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 1:1 randomized and paralleled 2 arms: Investigational product arm， Positive control arm

Arm	Type	Receives
Investigational product arm	Experimental	Drug: SHR-2004
Positive control arm	Active comparator	Drug: Enoxaparin Sodium Injection; Rivaroxaban Tablets

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (13 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SHR-2004Investigational product arm: SHR-2004	Drug	Investigational product arm
Enoxaparin Sodium Injection; Rivaroxaban TabletsPositive control arm: Enoxaparin Sodium Injection + Rivaroxaban Tablets	Drug	Positive control arm

Primary outcome

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.
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

7 secondary outcomes

The event rate of each component of the primary efficacy endpoint
Time frame: up to Day 28
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
The event rate of each component of the primary safety endpoint
Time frame: up to Day 28
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
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
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
The incidence and severity of adverse events.
Time frame: up to Day 85

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
Derived from this study: PubMed 42644221Jiang G, Tang J, Zhao H, Zhang K, Gao J, Yang B, Wang L, Yang H, Chen L, An R, Zhang H, Bu H, Tang J, Xu X, Ruan X, Xia B, Wang K, Wei L, Sheng X, Guo Z, Chen L, Wang W, Li J, Wang D, Zhan P, Guo Y, Wang Y, Dong Y, Zhu J. SHR-2004, a Humanized Monoclonal Antibody Targeting Factor XI, for Preventing Venous Thromboembolism After Ovarian Cancer Surgery: A Randomized, Active-Controlled Phase 2 Study. Am J Hematol. 2026 Aug 26. doi: 10.1002/ajh.70481. Online ahead of print.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06220123, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.