Sorafenib and Transarterial Chemoembolization for Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Hepatocellular carcinoma (HCC) as the third most common cause of cancer-related death has a very poor prognosis. Aim of this open label single arm non randomized pilot trial is the evaluation of the efficacy and safety of sorafenib in combination with TACE in patients with unresectable HCC. Efficacy ad safety will be compared with a historical TACE-only group of a placebo controlled TACE-trial.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Patients with histologically confirmed HCC not suitable for OLT or resection ( > 3 nodules, >5 cm diameter, vascular invasion, clinically significant portal hypertension, other contraindications against OLT)

• Child-Pugh Stage A or B

• Liver disease of any etiology

• Written informed consent (approved by the Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures

• Patient must be able to comply with the protocol

• Age ≥ 18 years

• Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to the administration of the Sorafenib.

Fertile women and men of childbearing potential ( < 2 years after last menstruation in women) must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)

• Haematology:

Absolute neutrophil count (ANC) > 1 x 109/L Platelet count > 40 x 109/L Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time ≥ 40%

• Biochemistry:

Total bilirubin < 5 mg/dL Serum creatinine < 3.0 mg/dL

• Life expectancy of > 3 months

Exclusion Criteria:

• Extrahepatic tumor spread

• Complete portal vein thrombosis (common trunk)

• Child-Pugh-Stage C

• Prior TACE or TAE

• Other experimental therapies for HCC

• Acute variceal bleeding within the last 2 weeks

• Large oesophageal varices ( > 5 mm diameter) without prophylactic band ligation

• Past or current history (within the last 2 years prior to randomisation) of malignancies except for the indication under this study and curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix

• History or evidence upon physical examination of CNS disease unless adequately treated (e.g., seizure not controlled with standard medical therapy or history of stroke within < 6 months), excluding hepatic encephalopathy

• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study

• Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants for therapeutic purposes

• Chronic, daily treatment with aspirin (>325mg/day)

• Pregnancy (positive serum pregnancy test) or lactation

• Uncontrolled hypertension

• Serious, non-healing wound, ulcer, or bone fracture

• Currently or recent (within the 30 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study

• Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents ( ≤ 6 months prior to study entry), myocardial infarction ( ≤ 6 months prior to study entry), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication

• Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Sorafenib/TACE or patient at high risk from treatment complications