Using degradable microspheres for treating liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.