Transcatheter Arterial Chemoembolization Combined With Sorafenib for Unresectable Hepatocellular Carcinoma

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring TACE, Sorafenib, overall survival, time to progression Read More

Inclusion Criteria:

1. Adults patients ( 18-75 years of age) with a diagnosis of HCC which is not amenable to surgical resection or local ablative therapy
2. Histological confirmed HCC or clinical/laboratory diagnosis of HCC or nodules larger than 2 cm with typical vascular features or AFP > 200
3. Patient must have quantifiable disease limited to the liver
4. Patients must have at least one tumor lesion that meets both of the following criteria:
5. The lesion can be accurately measured in at least one dimension according to RECIST criteria
6. The lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
7. ECOG performance status (PS) <2
8. No prior targeted antiangiogenic therapy. Metronomic chemotherapies are allowed. At least 4 weeks since prior systemic chemotherapy,At least 4 weeks since prior TACE, At least 4 weeks since prior interferon.
9. Not pregnant
10. No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only
11. No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis
12. No current infections requiring antibiotic therapy
13. Not on anticoagulation or suffering from a known bleeding disorder
14. No unstable coronary artery disease or recent MI

Exclusion Criteria:

1. Previous or concurrent cancer that is distinct in primary site or histology from HCC except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (Ta, Tis & T1), and any cancer curatively treated > 3 years prior to entry is permitted
2. Renal failure requiring hemo- or peritoneal dialysis
3. Child-Pugh B & C hepatic impairment
4. History of cardiac disease: > NY Heart Association (NYHA) class 2 congestive heart failure, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, and uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.
5. Active clinically serious infections (> CTCAEv3 grade 2)
6. Known history of HIV
7. Known central nervous system tumors including metastatic brain disease
8. History of organ allograft
9. Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
10. Known or suspected allergy to the investigational agents or any agent given in association with this trial.
11. Patients unable to swallow oral medications.
12. Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of the study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
13. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
14. Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg, despite optimal medical management
15. Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
16. Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug
17. Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
18. Serious non-healing wound, ulcer, or bone fracture