Hepatocellular carcinoma MedDRA version: 9.1 Level: LLT Classification code 10019695 Term: Hepatic neoplasm
Conditions
Interventions
Trade Name: sorafenib
Pharmaceutical Form: Tablet
INN or Proposed INN: sorafenib
Current Sponsor code: Bay 43-9006
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2
Sponsors
ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Patients with advanced/inoperable HCC not eligible for radical or loco-regional therapies ? Male or female patients >= 18 years of age ? Life expectancy of at least 12 weeks at screening ? Histologically or cytologically documented HCC ? At least one tumor lesion that meets both of the following criteria: 1) The lesion is measurable as per RECIST criteria, and 2) The lesion has not been subject to previous loco-regional therapy (such as radiation therapy, TACE, TAE, PEI, RFA, or cryoablation) ? Patients previously treated with loco-regional treatments are eligible provided that previously treated lesions are not selected as target lesions. Local therapy must be completed at least 4 weeks prior to the baseline scan ? ECOG PS of 0, 1, or 2 (Appendix 9.1) ? Cirrhotic status of Child-Pugh class A or B (Appendix 9.5) ? Barcelona-Clinic Liver Cancer (BCLC) stage B or C (Appendix 9.6) ? The following laboratory parameters: - Platelet count >= 60 x 109 /L - Haemoglobin >= 8.5 g/dL - Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous or concurrent cancer that is distinct in primary site or histology from HCC, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted • Renal failure requiring hemo- or peritoneal dialysis • History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) class 2; active coronary artery disease (CAD); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers ordigoxin), or uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted if there is no evidence of active CAD • Active clinically serious infections (> Grade 2 [NCI CTCAE] version 3.0) • Known history of human immunodeficiency virus (HIV) infection • Known Central Nervous System tumors including metastatic brain disease • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry • History of organ allograft • Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results • Patients unable to swallow oral medications • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression Free Survival (PFS) from randomization.;Secondary Objective: The secondary efficacy objectives are to assess the following variables between patients treated with Sorafenib versus BSC: ? Overall survival (OS) from enrolment ? Response rate (RR) ? Safety (AE) ? Progression free survival (PFS) from enrolment;Primary end point(s): Progression Free Survival (PFS) from randomization. | — |
Countries
Italy
Outcome results
None listed