Clinical trial · Interventional
Neoadjuvant Sorafenib Therapy Prior to Laser Ablation for Hepatocellular Carcinoma
Randomized Controlled Phase II Trial Of Neoadjuvant Sorafenib Therapy Prior to Thermal Ablation for Hepatocellular Carcinoma More Than 4 cm in Size
NCT01507064CI-TRIAL-00026322LANEXcompletedPhase 2ClinicalTrials.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 determine whether neoadiuvant therapy with sorafenib increases the efficacy of thermal ablation in inducing the necrosis of 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 |
|---|---|---|---|
| laser ablation (LA) | Procedure | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A
- description
- Patients who undergo to LA without sorafenib pretreatment
- interventionNames
- Procedure: laser ablation (LA)
- type
- EXPERIMENTAL
- label
- Group B
- description
- Patients who are treated with sorafenib before LA
- interventionNames
- Drug: Sorafenib
- Procedure: laser ablation (LA)
Primary outcomes (1)
- measure
- Effectiveness of sorafenib in increasing the effectiveness of laser ablation (LA)
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-80 years * ECOG = 0 or 1 * No liver decompensation (Child-Pugh \<8), bilirubin \<3mg/dL * Patients with unresectable HCC or who refused surgery * Confirmed HCC by pathology or by AASLD imaging guidelines * At least one HCC nodule (index tumor) accurately measured as 4-8cm in diameter on baseline imaging * No prior therapy for the index tumor * No prior systemic treatment for HCC within 4 weeks of study entry * LA clinically indicated for index tumor * Hemoglobin \>9.0 g/dl; Platelet count correctable to \>50,000/mm3; INR correctable to \<2.0. Exclusion Criteria: * Other severe concomitant diseases that may reduce life expectancy * Participants currently receiving any other study agents * Cancer vascular invasion or extrahepatic metastasis * Uncontrolled hypertension * Thrombotic events or myocardial infarction within the past 6 months * Hemorrhage/bleeding event within 4 weeks * Evidence of severe or uncorrectable bleeding diathesis or coagulopathy * Contraindication to or inability to undergo the LA procedure * Human immunodeficiency virus (HIV) infection * Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results * Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.