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)

Peking University First Hospital

Beijing, Beijing Municipality, China

Zhongda Hospital,Southeast University

Nanjing, Jiangsu, China

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NCT06190665


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