Clinical trial · Interventional
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
NCT06190665CI-TRIAL-00072965recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DEB-TACE with PVA microspheres | Device | — | UNRESOLVED |
| DEB-TACE with visualable microspheres | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Visualable microspheres
- description
- DEB-TACE with visualable microspheres
- interventionNames
- Device: DEB-TACE with visualable microspheres
- type
- ACTIVE_COMPARATOR
- label
- PVA microspheres
- description
- DEB-TACE with polyvinyl alcohol microspheres
- interventionNames
- Device: DEB-TACE with PVA microspheres
Primary outcomes (1)
- measure
- Disease control rate (DCR) for target lesions 1 month after the last TACE treatment
- timeFrame
- 1 month after last TACE treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.