Clinical trial · Interventional
Transarterial Ethanol Ablation(TEA) for Unresectable Hepatocellular Carcinoma(HCC)
A Comprehensive Analysis of Clinical Outcome, Treatment Toxicity and Tumor Response of Transarterial Ablation(TEA) for Unresectable Hepatocellular Carcinoma(HCC)
NCT01837381CI-TRIAL-00040367completedN/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)
The objective of this trial was to evaluate the clinical outcome, treatment toxicity and tumor response of TEA for 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TEA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Transarterial Ethanol Ablation (TEA)
- description
- Two treatment sessions at 2 months apart were given and started within 4 weeks after randomization.
- interventionNames
- Procedure: TEA
Primary outcomes (1)
- measure
- overall survival and treatment-related toxicity
- timeFrame
- Overall survival is studied from treatment to death from any cause, for an estimated period of up to 60 months. Treatment-related toxicity is studied up to 3 months after treatment
- description
- Overall survival was defined as date of treatment to date of death from any cause. Patients alive at the end of follow-up were censored. Clinical and laboratory data were documented prospectively at baseline, during hospitalization, and at 7, 14, and 30 day, and 3, 6, 9, and 12 months. Laboratory findings were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent by patient * Age above 18 years * Child-Pugh A or B cirrhosis * Eastern Cooperative Oncology Group(ECOG) performance score 2 or below * No serious concurrent medical illness * No prior treatment or surgery for HCC * Histologically or cytologically proven HCC except for lesions of size 1 to 2 cm, with typical features of HCC on two dynamic imaging techniques, or lesions larger than 2cm, with typical features on one dynamic imaging techniques, or lesions larger than 2cm with alpha feto protein(AFP) level \> 200 ng/mL * Unresectable disease without extra-hepatic involvement on chest X-ray(CXR) and CT * Massive expansive tumor type with measurable lesion on CT * Total tumor mass \< 50% liver volume * Tumor size ≤ 15cm in largest dimension * Tumor number ≤ 5 Exclusion Criteria: * History of prior malignancy except on the condition that the patient has been disease free for ≥ 3 years * Concurrent ischemic heart disease or heart failure * History of acute tumor rupture presenting with hemo-peritoneum * Serum creatinine level \> 180 umol/L * Biliary obstruction not amenable to percutaneous drainage * Child-Pugh C cirrhosis * History of hepatic encephalopathy * Intractable ascites not controllable by medical therapy * History of variceal bleeding within last 3 months; serum total bilirubin level ≥ 50 umol/L * Serum albumin level \< 25g/L * International normalized ratio(INR) \> 1.5 * Extrahepatic metastasis * Infiltrative or diffuse tumor * Tumor number \> 5 * Thrombosis of target hepatic artery * Partial or complete thrombosis of the main portal vein; tumor invasion of portal branch of contralateral lobe * Hepatic vein tumor thrombus * Significant arterio-portal venous shunt * Significant arterial-hepatic venous shunt
References
Publications (0)
Data not yet available
No reference posted for this study.