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

NCT05072041 | Recruiting DMC

• 1 other identifier: NEXTBIO-UIGB-HCC01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Tumor treatment response

  8 weeks

• Hepatic artery damage

  8 weeks

Study Arms (1)

Test group

EXPERIMENTAL

Degradable embolic microsphere (Nexsphere™)

Device: Nexsphere™

Interventions

Nexsphere™ DEVICE

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.

Test group

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients under the age of 19
• Chronic kidney disease (CDK) grade 4 or 5 patients
• Current or previous treatment with chemotherapy or radiation therapy or sorafenib or drug release chemoembolization (deTACE) after diagnosis of hepatocellular carcinoma
• \. 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

Sponsors & Collaborators

• Next Biomedical Co., Ltd.: lead

Study Sites (1)

Asan Medical Center

Seoul, Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Dong Il Gwon, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Hee Maeng, MS

CONTACT

+8228800860; jhmaeng@nextbiomedical.co.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 8, 2021
• Study Start: October 31, 2021
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)