Status:
COMPLETED
Neoadjuvant Sorafenib Therapy Prior to Laser Ablation for Hepatocellular Carcinoma
Lead Sponsor:
Cardarelli Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
BACKGROUND AND AIM Image-guided laser ablation (LA), minimally invasive procedure, is a potentially viable treatment option for achieving focal thermal destruction of hepatocellular carcinoma (HCC) th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01507064
Start Date
January 1 2012
End Date
September 1 2016
Last Update
March 7 2017
Active Locations (1)
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1
UOSC Epatologia - Cardarelli Hospital
Napoli, Italy, 80131