RecruitingNot ApplicableNCT06190665
DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC
DEB-TACE With Visualable Microspheres Versus PVA Microspheres for Hepatocellular Carcinoma: a Prospective, Multicenter, Randomized Controlled, Non-inferior Trial
Sponsor
Zhongda Hospital
Enrollment
188 participants
Start Date
Dec 19, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria4
- 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 Criteria11
- 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
Interventions
DEVICEDEB-TACE with visualable microspheres
Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with visualable microspheres
DEVICEDEB-TACE with PVA microspheres
Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with polyvinyl alcohol microspheres
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06190665
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