DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC

Southeast University

Status: Enrolling

Conditions: Hepatocellular Carcinoma

Treatments: Device: DEB-TACE with PVA microspheres; Device: DEB-TACE with visualable microspheres

Study type: Interventional

Funder types: Other

Identifiers

NCT06190665

CHANCE 2305

Details and patient eligibility

About

This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma.

Full description

This study is a prospective, multicenter, randomized controlled, non-inferior trial to evaluate the safety and efficacy of DEB-TACE with visualable microspheres or PVA microspheres for hepatocellular carcinoma.

Enrollment: 188 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CNLC Ia-IIIa HCC patients who require transarterial chemoembolization (TACE) and are not suitable for or refuse surgical resection, liver transplantation, or ablation Liver function classification of Child-Pugh A or B
• ECOG PS score of 0-2
• With measurable lesions that had not been embolized (if there are more than 3 lesions, select the three largest lesions as target lesions, and the maximum diameter of target lesion is ≤10cm)
• Agree to participate in this trial and voluntarily sign the informed consent form

Exclusion criteria

• Target lesions were embolized, or will require concomitant ablation or radiotherapy after TACE treatment(s)
• With diffuse liver tumor or extrahepatic metastasis, expected survival <6 months With sepsis or multiple organ dysfunction
• Severe liver dysfunction (Child-Pugh C) , or severerenal dysfunction (blood creatinine >2 mg/dL)
• Significant reductions in white blood cells or platelets (white blood cells <3.0×10^9/L, platelets <50×10^9/L, hemoglobin<60g/L) that cannot be corrected (except splenomegaly or chemotherapy-induced bone marrow suppression) Uncorrectable coagulation dysfunction (PT prolonged by >3 seconds above the upper limit of normal)
• With severe infection (>5 times the upper limit of normal white blood cells) The main portal vein was completely embolized by tumor thrombus without collateral blood supply
• With risk of ectopic embolization (uncorrected arteriovenous fistula or portal venous fistula) in the target lesion supplying arteries
• Angiography shows vascular anatomy obstruction or vasospasm that will affect the catheter placemenr embolic agent injection
• Known allergy to iodine-containing contrast agents, polyvinyl alcohol materials or anthracycline t ochemotherapy drugs
• Pregnant or lactating women
• Patients who are participating in other trial(s)
• Unsuitable for participation in this trial deemed by the researchers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

Visualable microspheres

Experimental group

Description:

DEB-TACE with visualable microspheres

Treatment:

Device: DEB-TACE with visualable microspheres

PVA microspheres

Active Comparator group

Description:

DEB-TACE with polyvinyl alcohol microspheres

Treatment:

Device: DEB-TACE with PVA microspheres