Using enoxaparin to prevent artery blockage after liver cancer chemotherapy

Enoxaparin for Preventing the Radical Artery Occlusion After the Transradial Access Hepatic Arterial Infusion Chemotherapy: A Multicenter, Randomized Controlled Trial.

This study is testing if using a blood thinner called enoxaparin can help prevent artery blockages in patients with liver cancer who are receiving a specific type of chemotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (estimated)
• Ages: 18 Years to 69 Years
• Sex: All
• Sponsor: Zhongshan Hospital (Xiamen), Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Xiamen, Fujian)
• Trial ID: NCT06293287 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of subcutaneous enoxaparin sodium as a prophylactic anticoagulant during transradial hepatic arterial infusion chemotherapy (HAIC) for patients with hepatocellular carcinoma. It is a single-blind, randomized, controlled, bicentric trial aimed at reducing the incidence of radial artery occlusion (RAO) following the procedure. The study includes patients aged 18-69 with specific liver cancer stages and function criteria, and it assesses their suitability for HAIC treatment. The trial is conducted at Zhongshan Hospital in Xiamen, China.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-69 diagnosed with hepatocellular carcinoma, specifically those in BCLC stage B or C with adequate liver function.

Not a fit: Patients with other primary tumors, serious comorbidities, or those not suitable for HAIC treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of artery occlusion, improving patient outcomes and comfort during liver cancer treatment.

How similar studies have performed: While the use of enoxaparin in similar contexts has been explored, this specific approach in the setting of transradial HAIC is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Signed informed consent; Age: 18-69 years;
2. Pathologically diagnosed with hepatocellular carcinoma or clinically in accordance with the American Association for the Study of Liver Diseases (AASLD) diagnostic criteria for hepatocellular carcinoma;
3. Clinical stage: BCLC stage B or C, liver function Child-Pugh class A or B$ (≤7 points)$, ECOG $score \<2$; suitable for HAIC treatment;
4. Adequate hematological and organ function, i.e., based on laboratory results obtained within 7 days before treatment, such as complete blood count, liver and kidney function, coagulation function, myocardial enzymes, etc., to assess whether the patient is suitable for HAIC treatment;
5. Low-risk patients for VTE (Venous Thromboembolism) according to the Padua scoring system (≤3 points).

Exclusion Criteria:

1. Concomitant primary tumors of other organs or histologically diagnosed tumors inconsistent with hepatocellular carcinoma;
2. Serious diseases of the heart, lungs, kidneys, or other organs;
3. Patients who have received trans-radial interventional surgery within the past 3 months;
4. Patients with thrombocytopenia $and/or $leukopenia due to cirrhosis-related coagulation disorders or splenic hyperfunction are excluded;
5. Preoperative radial artery ultrasound suggests vascular anatomical abnormalities, malformations, etc., unsuitable for trans-radial interventional treatment;
6. Patients with thrombotic diseases who are undergoing anticoagulation therapy;
7. Any unstable conditions or situations that may jeopardize the patient's safety or their compliance with the study;
8. Pregnant and lactating women.

Where this trial is running

Xiamen, Fujian

• Zhongshan Hospital, Fudan University (Xiamen Branch) — Xiamen, Fujian, China (Recruiting)

Study contacts

• Study coordinator: BoHeng Zhang, PHD

Conditions Radial Artery Occlusion