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

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Device: Nexsphere™

• Registration Number: NCT05072041
• Lead Sponsor: Next Biomedical Co., Ltd.

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.

Detailed Description

This study is a prospective study, and the purpose of this study is to investigate and collect clinical information on the safety and efficacy of degradable microsphere for hepatic artery chemoembolization in hepatocellular carcinoma patients. The primary purpose of this study was to evaluate the incidence of postembolism syndrome and liver function impairment after hepatic artery chemoembolization, and the secondary purpose was to evaluate tumor treatment response and hepatic artery damage after 1 month of hepatic artery chemoembolization.

Study Timeline

• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-09-28
• Study First Posted: 2021-10-08
• Study Start: 2021-10-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 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

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

Exclusion Criteria

1. Patients under the age of 19

2. Chronic kidney disease (CDK) grade 4 or 5 patients

3. Current or previous treatment with chemotherapy or radiation therapy or sorafenib or drug release chemoembolization (deTACE) after diagnosis of hepatocellular carcinoma

4. Pregnant, lactating, pre-menopausal and women not using effective contraceptive methods 6. Performance state European Cooperative Oncology Group (ECOG) > 1 7. Child-Poo Class C 8. Advanced hepatocellular carcinoma with vascular invasion or extrahepatic metastasis 9. Active Gastrointestinal Bleeding 10. Evidence of irreversible bleeding constitution 11. Encephalopathy that is not medically adequately controlled 12. Presence of ascites that is not medically controlled 13. Contraindications to Magnetic Resonance Imaging or Computed Tomography scan (e.g. metal implants) 14. Allergy to contrast media that cannot be managed by prevention 15. Contraindications to angiography 16. Contraindications to the administration of cisplatin anticancer drugs 17. Contraindications to hepatic artery embolization

• Extensive context-to-systemic shunts
• hepatofugal portal blood flow
• Serum bilirubin > 3.0 ㎎/dL
• Serum creatinine > 2.0 ㎎/dL
• Other symptoms that your doctor has determined to be exclusive.
• Irreversible blood clotting disorders 18. Others who are judged to be difficult for the principal investigator or principal investigator to conduct this clinical trial for other reasons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test group	Nexsphere™	Degradable embolic microsphere (Nexsphere™)

Primary Outcome Measures

Name	Time	Method
Incidence of postembolism syndrome	8 weeks	Nausea, vomiting, persistent pain, fever, and other
Incidence of liver function impairment	8 weeks	AFP, AST, ALT, BILI, GGT, BUN, and CREAT level

Secondary Outcome Measures

Name	Time	Method
Hepatic artery damage	8 weeks	Vessel dissection, vessel stenosis, vessel occlusion, vessel wall irregularity, and other
Tumor treatment response	8 weeks	Evaluation of tumor size by Magnetic Resonance Imaging or Computed Tomography scan at 4 and 8 weeks after embolization

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of