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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Device: Nexsphere™

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jin Hee Maeng, MS; Phone Number: +8228800860; Email: jhmaeng@nextbiomedical.co.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Asan Medical Center
    • Contact: Dong Il Gwon, MD, PhD; Phone Number: 82-2-30110-5001; Email: radgwon@amc.seoul.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

5. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Test group; Degradable embolic microsphere (Nexsphere™)

Device: Nexsphere™; Nexsphere™ is a yellow powder, made of 100% hydrophilic gelatin. It is used to make a suspension by mixing a contrast agent and physiological saline. The indications are hepatic artery chemoembolization, uterine artery embolization, prostate artery embolization, and treatment of various hemorrhagic diseases. It physically embolizes blood vessels and is decomposed within 4-8 weeks after intravascular injection.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Next Biomedical Co., Ltd.
• Investigators: Principal Investigator: Dong Il Gwon, MD, PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2021
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: NEXTBIO-UIGB-HCC01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No