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A prospective randomized controlled study of the effect of prophylactic anticoagulation therapy on the occurrence and safety of thrombotic events ORIENT31 treatment mode for advanced non-small cell lung cancer

A prospective randomized controlled study of the effect of prophylactic anticoagulation therapy on the occurrence and safety of thrombotic events ORIENT31 treatment mode for advanced non-small cell lung cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096949
Enrollment
Unknown
Registered
2025-02-10
Start date
2025-02-10
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer thromboembolism

Interventions

Non-anticoagulant group:non-anticoagulation
anticoagulant group:Rivaroxaban 10 mg QD PO

Sponsors

SHANGHAI CHEST HOSPITAL
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Prospective randomized controlled study, stratified: history of thoracic surgery, no history of thoracic surgery A randomized controlled study of prophylactic anticoagulation in patients with lung malignancies who received ORIENT31 mode antitumor therapy from February 2025 to February 2026 was included, 1:1 randomized, 73 patients with Khorana score of 2 or more were enrolled in each group Male or female aged 18-80 years (inclusive); Patients with pulmonary malignancies; No deep vein thrombosis/pulmonary embolism within one year; No anticoagulation therapy (warfarin, rivaroxaban, edoxaban, etc.); no atrial fibrillation; No antiplatelet therapy; He had previously received anticoagulation and has now discontinued Platelet count >= 100×10^9/L; hemoglobin >= 9 g/dL; Serum total bilirubin = 30ml/min (calculated according to Cockroft-Gault formula) The international normalized ratio (INR) was <= 1.5, and the partially activated prothrombin time (aPTT) was <= 1.5 times ULN; There are no contraindications to the use of anticoagulant drugs; Female subjects of childbearing potential should have a serum pregnancy test within 7 days before surgery and the result should be negative; Patient is able to understand and voluntarily sign a written informed consent document.

Exclusion criteria

Exclusion criteria: Patients with a Khorana score of less than 2 Is taking anticoagulant/antiplatelet/low molecular weight heparin or other medications for anticoagulation or antiplatelet therapy Surgery is planned within 1 month Patients with central lung cancer, tumor invasion of large blood vessels, or patients with symptoms of hemoptysis Pregnant or lactating women bleeding tendency, platelet count 1.5, and the partially activated prothrombin time (aPTT) was > 1.5 times ULN. Liver and kidney function impairment, serum total bilirubin > 1.5× upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 1.5 times ULN; Creatinine clearance<30ml/min (calculated according to the Cockroft-Gault formula) atrial fibrillation; Patients with allergies to anticoagulant drugs Various hematologic diseases that can cause anemia and bleeding: such as leukemia, thalassemia, aplastic anemia, etc Inability to understand or unwillingness to sign a written informed consent document Other conditions in which the investigator considers the patient not suitable for inclusion in the study

Design outcomes

Primary

MeasureTime frame
hemorrhagic events of the lower extremities during treatment;Pulmonary embolism or venous thrombosis events of the lower extremities during treatment;

Secondary

MeasureTime frame
Lung cancer treatment is discontinued;Tumor recurrence;

Countries

china

Contacts

Public ContactYINGHUA WANG

SHANGHAI CHEST HOSIPITAL

pen1019@hotmail.com+86 139 1669 0453

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026