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