Comparing two types of microspheres for treating liver cancer
DEB-TACE With Visualable Microspheres Versus PVA Microspheres for Hepatocellular Carcinoma: a Prospective, Multicenter, Randomized Controlled, Non-inferior Trial
This study is testing if a new type of microsphere treatment for liver cancer works just as well as a standard treatment to help patients with hepatocellular carcinoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Zhongda Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06190665 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with CNLC Ia-IIIa HCC who require TACE and have Child-Pugh A or B liver function.
Not a fit: Patients with severe liver dysfunction, extrahepatic metastasis, or those who have had prior embolization of target lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment options and outcomes for patients with hepatocellular carcinoma.
How similar studies have performed: Previous studies have shown promising results with TACE techniques, but the specific comparison of visualable microspheres to PVA microspheres is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.