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DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC
RECRUITINGN/ASponsored by Zhongda Hospital
Actively Recruiting
PhaseN/A
SponsorZhongda Hospital
Started2023-12-19
Est. completion2025-12-31
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06190665
Summary
This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma.
Eligibility
Age: 18 Years – 80 YearsHealthy volunteers accepted
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
Conditions4
CancerHepatocellular CarcinomaLiver CancerLiver Disease
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Actively Recruiting
PhaseN/A
SponsorZhongda Hospital
Started2023-12-19
Est. completion2025-12-31
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06190665