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Recruiting NCT06190665

DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC

No phase Interventional Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DEB-TACE with visualable microspheres, DEB-TACE with PVA microspheres.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

DEB-TACE With Visualable Microspheres Versus PVA Microspheres for Hepatocellular Carcinoma: a Prospective, Multicenter, Randomized Controlled, Non-inferior Trial

Overview

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

Detailed 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.

Interventions

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

Primary outcome measures

  • Disease control rate (DCR) for target lesions 1 month after the last TACE treatment [Time frame: 1 month after last TACE treatment]
Secondary outcome measures (6)
  • Visualization score of embolic area [Time frame: Immediately, 1 day, 1 month after first TACE treatment, and 1 month, 3 months, or 6 months since the last TACE treatment]
  • Embolization success rate of target lesions [Time frame: Immediately after each TACE treatment]
  • Equipment performance evaluation [Time frame: From the begin to immediately after each TACE treatment]
  • Disease control rate (DCR) for target lesions [Time frame: 1 month after the first TACE treatment, and 3 months after the last TACE treatment]
  • Objective response rate（ORR） [Time frame: 1 month after the first TACE treatment and 1 month, 3 months since the last TACE treatment]
  • Number of TACE treatments for target lesions [Time frame: 6 month since the last TACE treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Peking University First Hospital — Beijing
  • Zhongda Hospital，Southeast University — Nanjing

Identifiers

NCT: NCT06190665 · CHANCE 2305

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗