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Recruiting NCT05072041

Safety and Efficacy of Degradable Microsphere in Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

Trial Parameters

Condition Hepatocellular Carcinoma
Sponsor Next Biomedical Co., Ltd.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 150
Sex ALL
Min Age 19 Years
Max Age 79 Years
Start Date 2021-10-31
Completion 2025-08-31
Interventions
Nexsphere™

Brief Summary

The purpose of this study was to prospectively collect clinical data from patients who underwent hepatic artery chemoembolization using microspheres with different degradation times (2 hours, 1 day, 2 weeks) based on standard treatment.

Eligibility Criteria

Inclusion Criteria: 1. Adult patients aged 19 to 79 years 2. Patient who signed Informed Consent Form 3. Patients diagnosed with hepatocellular carcinoma by American Association for the Study of Liver Diseases (AASLD) and at least one of the following methods i. Magnetic resonance imaging (MRI) with early augmentation and delayed excretion of at least one solid liver lesion greater than 1 ㎝. ii. Contrast-enhanced computed tomography (CT) with early augmentation and delayed build-up of at least one solid liver lesion \>1 ㎝. iii. Lesions with inconclusive features require histological confirmation. 4. Patients should not be eligible for treatment by amputation or percutaneous resection or liver transplantation at the time of study enrollment. i. Patients who are not suitable for ablation due to lesion location may be enrolled. ii. Patients with recurrent hepatocellular carcinoma who are not suitable for amputation or resection may be enrolled. 5. Must be Child-Pugh A or B hepatocellular

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