DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC

Recruiting now · Not applicable

Conditions studied: Hepatocellular Carcinoma

In brief

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

Key facts

Study ID

NCT06190665

Run by

Zhongda Hospital

People needed

188

Starts

2023-12-19

Expected to finish

2026-12-31

Last updated by the study team

2024-01-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Peking University First Hospital — Beijing, Beijing Municipality, China (enrolling)
• Zhongda Hospital，Southeast University — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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