histologically proven advanced hepatocellular carcinoma (HCC) not suitable for resection or liver transplantation but without extrahepatic manifestations and without previous treatment for HCC MedDRA version: 9.1 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable
Conditions
Interventions
Trade Name: Nexavar
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sorafenib
Current Sponsor code: Sorafenib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
Heinrich-Heine-Universität Düsseldorf
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: – Patients with histologically confirmed HCC not suitable for resection or liver transplantation (> 3 tumors > 3 cm; one tumor > 5 cm; vascular invasion; corresponding to intermediate stage according to the BCLC staging criteria) – Age >= 18 years –Patients with measurable disease according to RECIST – Performance status ECOG 0-2 – Patients naive to treatment with respect to the HCC – Normal organ and bone marrow function defined as: – Hematopoetic: absolute neutrophil count > 1,500/mm3, platelet count > 100,000/mm3, hemoglobin > 9g/dL – INR =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: – Patient is eligible for liver resection or liver transplantation – Extrahepatic tumor manifestation – Thrombosis of the portal vein – > 8 points according to Child Pugh classification – Prior TACE or RFTA or any other local ablative treatment – Prior systemic anticancer chemotherapy or radiotherapy for HCC – Total bilirubin > 4.5 mg/dl – Life expectancy of less than 12 weeks – Esophageal varices grade III (any) or esophageal varices grade II with increased risk for bleeding (red wale signs, cherry spots, red coloration, hematocystic spots) without prophylactic band ligation – Cardiac disease: congestive heart failure > class II NYHA, unstable angina or new onset of angina or myocardial infarction within the past 6 months. Cardiac ventricular arrhythmias requiring antiarrhythmic therapy – Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal management – Known or suspected hyperthyroid state – Known brain metastasis. Patients with symptoms should undergo CT/MRT of the brain to exclude brain metastasis – Patients with seizure disorder requiring medication (such as steroids or antiepileptics) – History of organ allograft – Active clinically serious infections > CTCAE grade 2 – Thrombotic or embolic events including transient ischemic attacks within the past 6 months – Hemorrhage/bleeding event >= CTCAE grade 3 within 4 weeks of first dose of study drug – Acute variceal bleeding within the last 2 weeks – Serious non healing wound, ulcer or bone fracture – Evidence or history of bleeding diathesis or coagulopathy – Therapeutic anticoagulation with vitamin K antagonists such as warfarin, or with heparins or heparinoids. Low dose warfarin is permitted if INR is 100 mg/day – Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug – Known or suspected allergies to sorafenib, anthracyclines (including doxorubicin) or lipiodol (containing esters of iodinated fatty acids of poppy oil) or any agent given in the course of this trial – Contraindications to the use of sorafenib, doxorubicin or lipiodol as mentioned in the current summary of product characteristics – Previous cancer that is distinct in primary site or histology from HCC except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated 3 years prior to study entry – Substance abuse, medical or psychological condition that may interfere with the patient´s participation in the study – Participation in another clinical trial with any investigational study drug (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to enrollment – Incapability to give valid informed consent (including patients who are dependent on the sponsor or the investigator) – Lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: – determination of time to progression (TTP) ;Secondary Objective: Secondary objectives: determination of – overall survival (OS) – disease control rate (DCR: CR, PR or SD as best overall response (BOR)) – progression-free survival (PFS) – total number of TACE cycles – safety profile ;Primary end point(s): Progression of HCC or patient´s death | — |
Countries
Germany
Outcome results
None listed