Clinical trial · Interventional
Hepatectomy Versus Chemoembolization for Resectable Hepatocellular Carcinoma Beyond Milan Criteria
Hepatic Resection Versus Transarterial Chemoembolization as the Initial Treatment for Resectable Hepatocellular Carcinoma Beyond Milan Criteria
NCT02138981CI-TRIAL-00034113unknownPhase 4ClinicalTrials.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 purpose of this study is to compare the survival outcomes between hepatic resection and transarterial lipiodol chemoembolization (TACE) used as the initial treatment in patients with Resectable Hepatocellular Carcinoma Beyond Milan Criteria.
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 |
|---|---|---|---|
| Resectable Hepatocellular Carcinoma Beyond Milan Criteria | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemoembolization and Response-Dependent Resection | Procedure | — | UNRESOLVED |
| Immediate Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Immediate Resection
- description
- patients received immediate surgical hepatic resection
- interventionNames
- Procedure: Immediate Resection
- type
- EXPERIMENTAL
- label
- Chemoembolization and Response-Dependent Resection
- description
- patients underwent transarterial chemoembolization (TACE) as initial treatments, and only patients who showed good response were subjected to surgical resection.
- interventionNames
- Procedure: Chemoembolization and Response-Dependent Resection
Primary outcomes (1)
- measure
- overall survival time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * A diagnosis of HCC based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL). * The patient has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation. * The tumor beyound milan criteria. * The tumor was evaluated to be resectable by a same group of surgeon. * Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria * No serious concurrent medical illness * Not pregnant or breast-feeding patients * Cirrhotic status of Child-Pugh class A only * The following laboratory parameters: * Platelet count ≥ 80,000/µL * Hemoglobin ≥ 8.5 g/dL * Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 g/L * ASL and AST ≤ 5 x upper limit of normal * Serum creatinine ≤ 1.5 x upper limit of normal * INR ≤ 1.5 or PT/APTT within normal limits * Absolute neutrophil count (ANC) \>1,500/mm3 * Ability to understand the protocol and to agree to and sign a written informed consent document Exclusion Criteria: * Tumor vascular invasion or distant metastases * Significant renal impairment (creatinine clearance \< 30 mL/minute) or patients on dialysis * On anticoagulation or suffering from a known bleeding disorder * Unstable coronary artery disease or recent MI * Known history of HIV * History of organ allograft * Known or suspected allergy to the investigational agents or any agent given in association with this trial. * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug * Serious non-healing wound, ulcer, or bone fracture * Known central nervous system tumors including metastatic brain disease * severe Arterioportal Shunts or Arteriavein Shunts
References
Publications (0)
Data not yet available
No reference posted for this study.