Using degradable microspheres for treating liver cancer
Safety and Efficacy of Degradable Microsphere in Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma: a Prospective Comparative Study
This study is testing if using special microspheres during a liver cancer treatment can help patients feel better and avoid side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 19 Years to 79 Years |
| Sex | All |
| Sponsor | Next Biomedical Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Seoul, Seoul) |
| Trial ID | NCT05072041 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of degradable microspheres in transcatheter arterial chemoembolization for patients with hepatocellular carcinoma. It aims to collect clinical data on the incidence of postembolism syndrome and liver function impairment following the procedure. Additionally, the study evaluates the tumor treatment response and any hepatic artery damage one month after the chemoembolization. The microspheres used in the study have varying degradation times of 2 hours, 1 day, and 2 weeks.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 79 diagnosed with hepatocellular carcinoma who are not eligible for surgical interventions.
Not a fit: Patients who are suitable for surgical options like amputation, resection, or liver transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and reduce side effects for patients with hepatocellular carcinoma.
How similar studies have performed: Other studies have explored similar approaches in liver cancer treatment, showing promising results, but this specific method is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Seoul, Seoul
- Asan Medical Center — Seoul, Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Dong Il Gwon, MD, PhD — Asan Medical Center
- Study coordinator: Jin Hee Maeng, MS
- Email: jhmaeng@nextbiomedical.co.kr
- Phone: +8228800860
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.