Clinical trial · Interventional
Role of DEB-TACE Versus c-TACE in Treatment of HCC
Role of Drug Eluting Bead Transarterial Chemoebolization Versus Conventional Transarterial Chemoembolization in Treatment of Hepatocellular Carcinoma
- 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)
Hepatocellular carcinoma (HCC) is listed as the sixth most common cancer worldwide and the third most frequent cause of cancer-related mortality. The majority of HCC cases occurs stem from chronic liver disease and cirrhosis. Hepatocellular carcinoma accounts for approximately 70% to 90% of all primary liver cancers. Trans-arterial Chemoembolization is the most widely utilized and is considered the first-line treatment recommended for patients staged as intermediate HCC (Barcelona Clinic Liver Cancer stage B). If applied correctly, TACE can produce survival benefits without adversely affecting hepatic functional reserve. Two TACE techniques have been used since 2004, conventional TACE (c-TACE) and TACE with drug-eluting beads (DEB-TACE). Conventional TACE was evidenced first to treat intermediate stage HCC patients.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin-Eluting Beads | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Drug Eluting Bead Transarterial Chemoembolization
- description
- Drug Eluting Bead Transarterial Chemoembolization
- interventionNames
- Drug: Doxorubicin-Eluting Beads
- type
- ACTIVE_COMPARATOR
- label
- conventional Transarterial Chemoembolization
- description
- conventional Transarterial Chemoembolization
- interventionNames
- Drug: Doxorubicin-Eluting Beads
Primary outcomes (1)
- measure
- Tumor size
- timeFrame
- four-six weeks after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * \- Child-Pugh A or B cirrhosis. * ECOG performance status (PS) Grade 2 or below. * BCLC stage B or C. * No serious concurrent medical illness. * Radiologically or histologically proven HCC (an alpha-fetoprotein level \> 500 ug/ml in the presence of radiological findings suggestive of HCC in a patient with chronic HBV or HCV infection is considered eligible). * Unresectable and locally advanced disease without extra-hepatic disease. * Nodular tumor morphology with measurable lesion on CT with less than 50% involvement of liver by HCC. * Size of largest tumor is less than or equal to 15cm in largest dimension. * Number of main tumor is less than or equal to 5, excluding associated small satellite lesions. * Patent main portal vein. Exclusion Criteria: * \- Child-Pugh C cirrhosis (evidence of poor liver function). * History of significant concurrent medical illness such as ischemic heart disease or heart failure. * Serum creatinine level \> 2 mg/dL. * Presence of extrahepatic metastasis. * Predominantly infiltrative lesion. * Diffuse tumor morphology with extensive lesions involving both lobes. * Hepatic artery thrombosis. * Thrombosis of the main portal vein. * Tumor invasion of portal branch of contralateral lobe.
References
Publications (4)
- BACKGROUNDCho SM, Chu HH, Kim JW, Kim JH, Gwon DI. Initial Transarterial Chemoembolization (TACE) Using HepaSpheres 20-40 microm and Subsequent Lipiodol TACE in Patients with Hepatocellular Carcinoma > 5 cm. Life (Basel). 2021 Apr 18;11(4):358. doi: 10.3390/life11040358. PMID 33919658
- BACKGROUNDGholam PM, Iyer R, Johnson MS. Multidisciplinary Management of Patients with Unresectable Hepatocellular Carcinoma: A Critical Appraisal of Current Evidence. Cancers (Basel). 2019 Jun 22;11(6):873. doi: 10.3390/cancers11060873. PMID 31234476
- BACKGROUNDLi H, Wu F, Duan M, Zhang G. Drug-eluting bead transarterial chemoembolization (TACE) vs conventional TACE in treating hepatocellular carcinoma patients with multiple conventional TACE treatments history: A comparison of efficacy and safety. Medicine (Baltimore). 2019 May;98(21):e15314. doi: 10.1097/MD.0000000000015314. PMID 31124925
- BACKGROUNDMelchiorre F, Patella F, Pescatori L, Pesapane F, Fumarola E, Biondetti P, Brambillasca P, Monaco C, Ierardi AM, Franceschelli G, Carrafiello G. DEB-TACE: a standard review. Future Oncol. 2018 Dec;14(28):2969-2984. doi: 10.2217/fon-2018-0136. Epub 2018 Jul 10. PMID 29987957