E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients HCV RNA positive with HCC, surgical resection or percutaneous tumor ablation procedures |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10029104 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1) Evaluation of the overall survival in anti-HCV, HCV RNA positive patients with HCC who underwent surgical and/or loco-regional tumor treatments; 2) Evaluation of progression-free survival in the same population. |
|
E.2.2 | Secondary objectives of the trial |
1) The rate of adverse events and toxicities; 2) Symptoms and quality of life improvements; 3) Variations of the circulating serum cytokine levels and angiogenetic markers; 4) Variations of the circulating and cell-associated viral load. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
time to progression of disease |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |