Clinical trial · Interventional
Transarterial Ethanol Ablation (TEA) Versus Transcatheter Arterial Chemoembolisation (TACE) for Hepatocellular Carcinoma
A Randomized Controlled Trial of Transarterial Ethanol Ablation (TEA) With Lipiodol-Ethanol Mixture (LEM) Versus Transcatheter Arterial Chemoembolisation (TACE) for Unresectable Hepatocellular Carcinoma
NCT00467974CI-TRIAL-00016701completedPhase 3ClinicalTrials.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)
The current randomized controlled trial comparing LEM and TACE aims to evaluate the safety and efficacy of LEM as compared to TACE for treating patients with unresectable HCC.
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 |
|---|---|---|---|
| TACE | Procedure | — | UNRESOLVED |
| TEA with LEM | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- TEA with LEM
- interventionNames
- Procedure: TEA with LEM
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- TACE
- interventionNames
- Procedure: TACE
Primary outcomes (2)
- measure
- overall survival
- timeFrame
- 3 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patient factor * Age \> 18 * Child-Pugh A or B cirrhosis * ECOG performance status Grade 2 or below * No serious concurrent medical illness * No prior treatment (including surgery) for HCC Tumor factor * Histologically or cytologically proven HCC (an alphafetoprotein level \> 500 ug/ml in the presence of radiological findings suggestive of HCC in a patient with chronic HBV or HCV infection can be considered eligible at investigator's discretion) * Unresectable and locally advanced disease without extra-hepatic disease * Massive expansive or nodular tumor morphology with measurable lesion on CT * Size of largest tumor \<= 15cm in largest dimension * Number of main tumor \<= 5, excluding associated small satellite lesions. Exclusion Criteria: Patient factor * History of prior malignancy except skin cancer * History of significant concurrent medical illness such as ischemic heart disease or heart failure * History of acute tumor rupture * Serum creatinine level \> 180 umol/L * Presence of biliary obstruction not amenable to percutaneous drainage * Child-Pugh C cirrhosis Evidence of poor liver function * History of hepatic encephalopathy, or * Intractable ascites not controllable by medical therapy, or * History of variceal bleeding within last 3 months, or * Serum total bilirubin level \> 50 umol/L, or * Serum albumin level \< 28g/L, or * INR \> 1.3 Tumor factor * Presence of extrahepatic metastasis * Predominantly infiltrative lesion * Diffuse tumor morphology with extensive lesions involving both lobes. Vascular complications * Hepatic artery thrombosis, or * Partial or complete thrombosis of the main portal vein, or * Tumor invasion of portal branch of contralateral lobe, or * Hepatic vein tumor thrombus, or * Significant arterioportal shunt not amenable to shunt blockage, or * Significant arteriovenous shunt not amenable to shunt blockage
References
Publications (1)
- DERIVEDYu SC, Hui JW, Hui EP, Chan SL, Lee KF, Mo F, Wong J, Ma B, Lai P, Mok T, Yeo W. Unresectable hepatocellular carcinoma: randomized controlled trial of transarterial ethanol ablation versus transcatheter arterial chemoembolization. Radiology. 2014 Feb;270(2):607-20. doi: 10.1148/radiol.13130498. Epub 2013 Oct 28. PMID 24126369