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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-79
SponsorNext Biomedical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 ㎝.

Patients should not be eligible for treatment by amputation or percutaneous resection or liver transplantation at the time of study enrollment.

Disqualifiers

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

Extensive context-to-systemic shunts

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Test groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of postembolism syndrome

Nausea, vomiting, persistent pain, fever, and other

Time frame
8 weeks
2

Incidence of liver function impairment

AFP, AST, ALT, BILI, GGT, BUN, and CREAT level

Time frame
8 weeks

Secondary outcomes

1

Tumor treatment response

Evaluation of tumor size by Magnetic Resonance Imaging or Computed Tomography scan at 4 and 8 weeks after embolization

Time frame
8 weeks
2

Hepatic artery damage

Vessel dissection, vessel stenosis, vessel occlusion, vessel wall irregularity, and other

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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