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NCT05072041Recruiting

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

Source: ClinicalTrials.gov · Last updated 14 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
150 (estimated)
First submitted
28 Sept 2021
Start date
31 Oct 2021
Primary completion date
31 Aug 2025
Lead sponsor
Next Biomedical Co., Ltd.
NCT number
NCT05072041

What you commit to

  • Study type: Interventional
  • Planned participants: 150
  • From 31 Oct 2021 to the primary completion date, 31 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Chronic kidney disease (CDK) grade 4 or 5 patients
  • 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

Lab values

  • Serum bilirubin \> 3.0 ㎎/dL
  • Serum creatinine \> 2.0 ㎎/dL

Age

  • Patients under the age of 19

Other

  • Extensive context-to-systemic shunts
  • hepatofugal portal blood flow
  • Other symptoms that your doctor has determined to be exclusive.

Who the study is looking for

  • 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 ㎝.
    • Contrast-enhanced computed tomography (CT) with early augmentation and delayed build-up of at least one solid liver lesion \>1 ㎝.
    • 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.
    • Patients who are not suitable for ablation due to lesion location may be enrolled.
    • 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.
    • 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

Age in the registry: 19 years to 79 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.