Safety and Efficacy of Degradable Microsphere in Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma: a Prospective Comparative Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 79
Healthy Volunteers: f
View:

• Adult patients aged 19 to 79 years

• Patient who signed Informed Consent Form

• 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.

• 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.

• Must be Child-Pugh A or B hepatocellular carcinoma, and must satisfy the following criteria.

• i. Tumor lesion size from 1 ㎝ to 10 ㎝ ii. Number of tumors 1-7 iii. Physical activity European Cooperative Oncology Group (ECOG) ≤ 1 without vascular involvement

• Patients who can be followed up until the end of the study and whose life expectancy is 6 months or longer

Locations
Other Locations
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Contact Information
Primary
Jin Hee Maeng, MS
jhmaeng@nextbiomedical.co.kr
+8228800860
Time Frame
Start Date: 2021-10-31
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 150
Treatments
Experimental: Test group
Degradable embolic microsphere (Nexsphere™)
Sponsors
Leads: Next Biomedical Co., Ltd.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.