Phase II Study Evaluating Transarterial Chemoembolization (TACE) in Combination With Sorafenib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)
Inclusion Criteria:
- with histologically confirmed HCC not suitable for resection or liver transplantation
- Patients with measurable disease according to RECIST
- Performance status ECOG 0-2
- Normal organ and bone marrow function (defined)
- Women of childbearing potential must have performed a negative serum pregnancy test
- male or female patients must use an approved contraceptive method during treatment
and for 3 months after end of treatment after the end of treatment with study
medication
- Written informed consent
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 without prophylactic band ligation
- Cardiac diseases (defined)
- Uncontrolled hypertension
- Known or suspected hyperthyroid state
- Known brain metastasis
- Patients with seizure disorder requiring medication
- History of organ allograft
- Active clinically serious infections > CTCAE grade 2
- Thrombotic or embolic events
- Hemorrhage/bleeding event (defined)
- Acute variceal bleeding
- Therapeutic anticoagulation with vitamin K antagonists (defined)
- Known or suspected allergies to sorafenib, doxorubicin or lipiodol or any agent given
in the course of this trial
- Contraindications to the use of sorafenib, doxorubicin or lipiodol
- Previous cancer distinct in primary site or histology from HCC (defined)
- substance abuse
- Participation in another clinical trial with any investigational study drug
- Lactating women
- Incapability to give valid informed consent