Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients

• Status: Not yet recruiting
• Trial end date: 2026-11-30
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of edoxaban in the prevention of tumor catheter-related thrombosis (CVC/PICC) in high-risk patients

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Treatments: Edoxaban

Criteria

Inclusion Criteria:

1. Age≥18.

2. Cancer patients with a catheter-related thrombus risk prediction model score ≥ 19.6.

3. ECOG score≤2.

4. Expected survival period over 6 months.

5. Malignant tumor was diagnosed by pathology and central venous catheterization was successfully completed.

6. Signing of informed consent voluntarily.

Exclusion Criteria:

1. Unknown location of the primary tumor.

2. Allergy to the active ingredient of edoxaban tablets or other excipients.

3. There is clinically significant active bleeding.

4. Platelet <50×109/L.

5. Liver disease with coagulopathy or clinically relevant bleeding risk.

6. A lesion or condition with a significant risk of major bleeding, such as current or recent gastrointestinal ulcer, recent brain or spinal injury, recent brain, spinal, or ophthalmic surgery, recent intracranial hemorrhage, esophageal varices, arteriovenous malformations, vascular aneurysms, or major intravertebral or intracerebral vascular malformations.

7. Concomitant therapy with any other anticoagulant, such as Unfractionated heparin (UFH), Low molecular heparin (Low molecular weight heparin, LMWH) (enoxaparin, dalteparin, etc.), heparin derivative (fondaparinux, etc.), oral anticoagulant (warfarin, dabigatran, rivaroxaban, apixaban, etc.), except in the special case of administration of UFH to maintain central venous catheter patency.

8. Surgical treatment is planned for the duration of the study.

9. Uncontrolled co-morbidities include, but are not limited to:

Serious, uncontrolled infection. Symptomatic heart failure (New York Heart Association class II-IV) or symptomatic or poorly controlled arrhythmias Uncontrolled hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) despite standard treatment.

Any arterial thromboembolic event within 6 months before enrollment. Tumor invasion of large vessels. History of deep vein thrombosis, pulmonary embolism, or other major thromboembolism within 3 months before enrollment.

10. History of gastrointestinal perforation within 6 months before enrollment.

11. Pregnant or breastfeeding women.

12. Oral contraceptives.

13. Conditions considered unsuitable for inclusion in this study.