SE OF SORAFENIB IN THE PREVENTION OF RELAPSE OF RESECTED/ABLATED HEPATOCELLULAR CARCINOMA (HCC) IN PATIENTS WITH HEPATITIS C VIRUS CHRONIC INFECTION. - ND

• Conditions: Patients HCV RNA positive with HCC,surgical resection or percutaneous tumor ablation procedures; MedDRA version: 9.1Level: SOCClassification code 10029104

• Registration Number: EUCTR2010-020678-41-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-10
• Last Update Posted: 2 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

? Adult patients (age =70; = 18).
? Anti-HCV, HCV RNA positivity.
? Surgical resection or percutaneous tumor ablation procedures at least two weeks before.
? Child A or B cirrhosis.
? Performance status ECOG 0-2.
? No prior targeted anti-angiogenetic therapy or at least 4 weeks since prior systemic chemotherapy.
? At least 4 weeks since prior antiviral therapy
? Not pregnant women.
? No significant renal impairment (creatinine clearance < 30mL/min) or patients on dialysis.
? No current infections requiring antibiotic therapy.
? Not on anticoagulation or suffering from a bleeding disorder.
? No unstable coronary artery disease or recent myocardial infarction.
? Platelet count = 40,000/µL.
? Hemoglobin = 8.0 g/dL.
? Total bilirubin = 3 mg/dL
? AST and ALT= 5x normal upper limits.
? PT INR = 2.3 or PT = 6 seconds
? Absolute neutrophil count = 1,500/mm3.
? Ability to understand the protocol and to agree to and sign a written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous or concurrent cancer distinct from HCC, except any cancer curatively treated > 3 years prior to entry in the study.
? Renal failure requiring hemo- or peritoneal dialysis.
? Child-Pugh C hepatic impairment
? History of cardiac disease: > New York Heart Association (NYHA) class 2 congestive heart failure, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta-blockers or digoxin, and uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.
? Active clinically serious infections.
? Other viral infections (HBV, HIV).
? Known central nervous system tumors including metastatic brain disease.
? History of organ allograft.
? Substance abuse (current), psychological or social conditions that may interfere with the patient`s
participation in the study or evaluation of the study results.
? Known or suspected allergy to the investigational agents given in association with this trial.
? Patients unable to swallow oral medications.
? Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of the study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
? Cardiac ventricular arrhythmias.
? Uncontrolled hypertension (> 159/90 mmHg) despite optimal medical management.
? Thromboembolic events such as cerebrovascular accident, including transient ischemic attacks within the past 6 months.
? Any hemorrhage/bleeding event within 4 weeks of first dose of study drug.
? Major surgery within 6 weeks of start of study drug.
? Radiotherapy during study or within 3 weeks prior to start of study drug.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1) Evaluation of the overall survival in anti-HCV, HCV RNA positive patients with HCC who underwent surgical and/or loco-regional tumor treatments;<br>2) Evaluation of progression-free survival in the same population.;Secondary Objective: 1) The rate of adverse events and toxicities;<br>2) Symptoms and quality of life improvements;<br>3) Variations of the circulating serum cytokine levels and angiogenetic markers;<br>4) Variations of the circulating and cell-associated viral load.;Primary end point(s): time to progression of disease