Neoadjuvant Sorafenib Therapy Prior to Laser Ablation for Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardarelli Hospital
• Treatments: Niacinamide; Sorafenib

Criteria

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.