Neoadjuvant Sorafenib Therapy Prior to Laser Ablation for Hepatocellular Carcinoma

NCT01507064 | Completed Phase 2

• 1 other identifier: epatologia2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; sorafenib; laser ablation

Outcome Measures

Primary Outcomes (1)

• Effectiveness of sorafenib in increasing the effectiveness of laser ablation (LA)

  Measures: complete tumor ablation rate (according to the mRECIST), time-to-recurrence (in complete response subgroup), time-to-progression (in partial response subgroup).

  1 year

Secondary Outcomes (2)

• Safety of sorafenib treatment prior to LA.

  6 months

• Survival in the two treatment groups

  2 years

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients who undergo to LA without sorafenib pretreatment

Procedure: laser ablation (LA)

Group B

EXPERIMENTAL

Patients who are treated with sorafenib before LA

Drug: Sorafenib; Procedure: laser ablation (LA)

Interventions

Sorafenib DRUG

tablets 200mg dosage: 400mg bid duration: 4 weeks

Also known as: Nexavar

Group B

laser ablation (LA) PROCEDURE

For LA, we use a commercially available system (Echolaser XVG system, Esaote El.En., Florence, Italy) and four optical fibers,inserted into the tumor through four 21-gauge needles. The tips of the needles will be positioned at a distance of 15mm from each other. When, after LA treatments, CT or MRI findings show a residual nodule activity of 10% or less, percutaneous ethanol injection may be done. If the residual activity is of 50% or more transarterial chemoembolization may be used.

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardarelli Hospital: lead

Study Sites (1)

UOSC Epatologia - Cardarelli Hospital

Napoli, 80131, Italy

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib; Laser Therapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hepatology

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 10, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2016
• Last Updated: March 7, 2017

Record last verified: 2017-03

Locations

IT (1)