A phase IV study of efficacy and safety of Sorafenib in patients with hepatocellular carcinoma after radiological progressio
- Conditions
- Advanced stage hepatocellular carcinoma (stage C of BCLC classification)MedDRA version: 14.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-006194-26-ES
- Lead Sponsor
- JOSE LUIS MONTERO ALVAREZ
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1. Male or female patient older than 18 years old.
2. Diagnosis of advanced HCC according to the AASLD Guidelines.
3. HCC stage B with contraindication to transarterial chemoembolization (TACE) or stage C according to Barcelona Clinic Liver Cancer (BCLC) staging classification.
4. Sorafenib treatment-naive patient.
5. Child-Pugh class A (5-6 points) or class B (7 points), without ascites (mild ascites controlled with diuretics is allowed) and encephalopathy. Child-Pugh status must be calculated based on clinical findings and laboratory results during 30 days before inclusion in the study.
6. ECOG Performance Status lower than 2.
7. Adequate liver, renal and bone marrow function as shown by:
AST y ALT lower than 5 x ULN (upper limit of normal); bilirubin lower than 2 mg/dL; INR lower than 2; absolute neutrophil count (ANC) higher than 1.2 x 103 per ml ; platelets higher than 70 x 103 per ml ; serum creatinine lower than 1.5 mg/dL.
8. Written informed consent.
9. Women of chilbearing potential (WOCBP) must have a negative serum pregnancy test performed in the screening visit.
WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilizatiion (hysterectomy, bilateral tubal ligation or bolateral oophorectomy) or is not postmenopausal. Post menopause is defined as an amenorrhea state longer than 12 consecutive months.
10. Men and women enrolled in this trial must used adequate barrier bith control measure since two weeks prior to the start of investigational product, during the course of the trial and two weeks after the last dose of investigational product.
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 66
1. Prior liver transplantation.
2. Known history of HIV infection.
3. Previous/concurrent cancer (distinct from HCC) known during the last 3 years, except for cervical carcinoma in situ, basal cells carcinoma and superficial bladder tumors.
4. History of cardiovascular disease:
- uncontrolled hypertension, defined as systolic blood pressure higher than 150 mmHg or diastolic pressure higher than 90 mmHg despite optimal medical management.
- active coronary disease, unstable or newly diagnosed angina or myocardial infarction less than 12 months prior to study entry.
- cardiac arrhythmias requiring anti-arrhytmic therapy other than beta blockers or digoxin.
- congestive heart failure higher than NYHA class 2.
5. Subjects with history of bleeding diathesis.
6. History of gastrointestinal bleeding within 30 days of randomizaion.
7. Subjects with a history of esophageal varices bleeding without efffective therapy and/or treatment to prevent bleeding recurrence.
8. Abuse to drugs, clinical or psychological states that might interfere in the participation or evaluation of study results.
9. Subjects on warfarin, acenocumarol, fenprocumone.
10.Female patients who are pregnant or breast feeding.
11.Unable or unwilling subjects to give informed consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine efficacy of Sorafenib in advanced hepatocellular carcinoma (stage C of BCLC classification) after radiological progression.;Secondary Objective: -To determine safety of Sorafenib in advanced hepatocellular carcinoma (stage C of BCLC classification) after radiological progression.<br>-To assess quality of life.<br>-To evaluate adherence to Sorafenib treatment.<br><br>ADDITIONAL EXPLORATORY OBJECTIVE:<br>To determine if growth factors related to neoangiogenesis, as EGF,FGF-2,VEGF and PDGF, could be biomarkers of respond to Sorafenib treatment in advanced hepatocellular carcinoma.;Primary end point(s): Overall Survival (OS);Timepoint(s) of evaluation of this end point: At the end of the clinical trial
- Secondary Outcome Measures
Name Time Method