Comparing two types of microspheres for treating liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of drug-eluting bead transarterial chemoembolization (DEB-TACE) using visualable microspheres compared to PVA microspheres in patients with hepatocellular carcinoma (HCC). It is a prospective, multicenter, randomized controlled trial designed to determine if the visualable microspheres are non-inferior to PVA microspheres in terms of treatment outcomes. Participants will be selected based on specific inclusion criteria, including liver function and the presence of measurable lesions. The trial aims to provide insights into the effectiveness of these two embolization techniques for HCC management.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Gao-Jun Teng — Zhongda Hospital
• Study coordinator: Hai-Dong Zhu
• Email: zhuhaidong9509@163.com
• Phone: +86-25-83272121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.