DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC

Last updated: January 10, 2024
Sponsor: Zhongda Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Abdominal Cancer

Liver Disorders

Treatment

DEB-TACE with PVA microspheres

DEB-TACE with visualable microspheres

Clinical Study ID

NCT06190665
CHANCE 2305
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • CNLC Ia-IIIa HCC patients who require transarterial chemoembolization (TACE) and arenot suitable for or refuse surgical resection, liver transplantation, or ablationLiver 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 targetlesion is ≤10cm)
  • Agree to participate in this trial and voluntarily sign the informed consent form

Exclusion

Exclusion Criteria:

  • Target lesions were embolized, or will require concomitant ablation or radiotherapyafter TACE treatment(s)
  • With diffuse liver tumor or extrahepatic metastasis, expected survival <6 months Withsepsis 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 (exceptsplenomegaly or chemotherapy-induced bone marrow suppression) Uncorrectablecoagulation 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 mainportal vein was completely embolized by tumor thrombus without collateral blood supply
  • With risk of ectopic embolization (uncorrected arteriovenous fistula or portal venousfistula) in the target lesion supplying arteries
  • Angiography shows vascular anatomy obstruction or vasospasm that will affect thecatheter placemenr embolic agent injection
  • Known allergy to iodine-containing contrast agents, polyvinyl alcohol materials oranthracycline 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

Study Design

Total Participants: 188
Treatment Group(s): 2
Primary Treatment: DEB-TACE with PVA microspheres
Phase:
Study Start date:
December 19, 2023
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Active - Recruiting

  • Zhongda Hospital,Southeast University

    Nanjing, Jiangsu 210009
    China

    Active - Recruiting

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