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Clinical Trials in China / NCT06190665
Recruiting Not applicable

DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC

NCT06190665 · tracked via the Priya Life Science China tracker
Sponsor
Zhongda Hospital
Phase
Not applicable
Started
2023-12-19
Last updated
2024-01-12

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

DEB-TACE with visualable microspheresDEB-TACE with PVA microspheres

DEB-TACE with visualable microspheres: Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with visualable microspheres

DEB-TACE with PVA microspheres: Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with polyvinyl alcohol microspheres

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Peking University First Hospital Beijing Beijing Municipality Recruiting
Zhongda Hospital,Southeast University Nanjing Jiangsu Recruiting

More Zhongda Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06190665 on ClinicalTrials.gov ↗ ← All trials in China