Hepatocellular carcinoma resectable MedDRA version: 12.1 Level: LLT Classification code 10019830 Term: Hepatocellular carcinoma resectable
Conditions
Interventions
Trade Name: Nexavar
Product Name: Sorafenib
Product Code: not applicable
Pharmaceutical Form: Coated tablet
INN or Proposed INN: SORAFENIB
CAS Number: 284461-73-0
Current Sponsor code: not applicable
Sponsors
GERCOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent. 2. Histological proven diagnosis of HCC. Patients with fibrolamellar or mixed histology are eligible. 3. Patient eligible for conservative hepatic resection, liver resection, with curative intent. 4. No cirrhosis or cirrhosis status with Child-Pugh score = 7 (status A or B7). 5. Men or women of at least 18 years of age. 6. Body mass index between 18.5 and 30 kg/m2 (WHO normal range: 18.5 – 25). 7. Life expectancy = 3 months. 8. Performance status 0 to 1 (ECOG). 9. Ability to swallow oral compound. 10. Patients must have adequate organ function including : - Haematologic: WBC > 3000, ANC > 1500, platelets = 100,000, haemoglobin = 9 g/dl. - Hepatic: Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient previous or candidate to orthotopic liver transplantation. 2. Any prior systemic or loco-regional treatment for HCC. 3. Cirrhotic status with Child-Pugh score > 7 (status B8-9 or C). 4. Any criterion for unresectability or medical condition that eventually contraindicates surgical resection at baseline evaluation. 5. Presence of any serious concomitant systemic disorders incompatible with the study, including uncontrolled hypertension, i.e. > 150/100 mmHg despite optimal therapy), or active uncontrolled infection, or active alcoholism. 6. Previous history of organ allograft or another malignancy (other than basal or squamous cell skin carcinoma or cured in situ cervical carcinoma) within 5 years of study entry. 7. Known history or presence of metastatic brain or meningeal tumors. Seizure disorder requiring medications such as anti-epileptics. 8. Concomitant treatment with full-dose anticoagulants (deep vein or catheter-associated thrombosis prophylaxis is permitted). 9. Cardiac arrhythmias requiring anti-arrhythmics (excluding beta-blockers or digoxin for chronic atrial fibrillation), active coronary artery disease or ischemia (myocardial infarction within the last 6 months), congestive heart failure > New York Heart Association (NYHA) Class II, pulmonary embolism or gastrointestinal bleeding during the 6 months prior to study entry. 10. Known history of human immunodeficiency virus (HIV) infection, or chronic hepatitis B or C. 11. Active clinically serious bacterial or fungal infections, i.e. grade 2 CTC [CTCAE] Version 3. 12. Any condition that is unstable or that could jeopardize the safety of the subject and his/her compliance with the study. Substance abuse or medical, psychological, or social conditions that could interfere with the subject’s adhesion to the study. 13. Known or suspected allergy to the investigational agent or to any agent given concomitantly. 14. Presence of asthenia or rash greater than CTC grade 1 at enrolment. 15. Treatment with any other investigational medicinal product within 28 days prior to study entry. 16. Chronic co-administration of CYP3A4 inducers such as rifampin, or millepertuis (hypericum perforatum), or phenytoin, or carbamazepine, or phenobarbital, or dexamethasone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess anti-tumor activity of sorafenib in tumor samples from patients with resectable hepatocellular carcinoma (HCC);Secondary Objective: * To characterize pathologic findings in sorafenib pre-treated patients undergoing surgical resection for HCC. * To evaluate the number of R0 resections * To correlate pathological biomarkers changes in resected tumors after 4-week treatment with sorafenib in comparison with biopsies obtained prior to treatment. * To evaluate plasma biomarkers at baseline, Day 28 and the day before surgery. * To identify potential biomarkers of sensitivity and/or resistance on biological and pathological samples. * To characterize the safety profile of sorafenib in the study population. * To assess the tolerance of liver resection after sorafenib treatment. ;Primary end point(s): pathological changes | — |
Countries
France
Outcome results
None listed