To Evaluate Safety and Efficacy of FB-1603 in Hepatocellular Carcinoma Patient Receiving Transarterial Chemoembolization

Prior treatment

• Patients who are taking any prohibited drugs that might interfere the trial
• Patients with active infections (infection requiring the use systemic antibiotics) within 4 weeks prior to the screening visit

Other illness

• Any condition representing a contraindication to TACE as determined by the investigators
• Acute liver failure or liver function decompensation patient perform, such as hepatic encephalopathy, and ascites
• Patients with acute or chronic active hepatitis B or C infection and are recommended to receive HBV or HCV treatment, e.g., Patient with HBV DNA ≥ 20,000 IU/ml or with detectable HCV RNA
• Patients who have severe organic diseases on heart, lungs, brain, kidney, and gastrointestinal tract by the judgment of investigators

Other

• Patients with evidence of macrovascular invasion
• Patients with evidence of extrahepatic spread
• Patients with chronic pancreatitis
• Patients who are not able to express the chief complaint, for example, the patients with psychosis and severe neurosis

• Aged 18-85 years (inclusive) of either gender
• Willing and able to provide signed informed consent
• Confirmed diagnosis of hepatocellular carcinoma by radiology, histology, or cytology
• Subject has the willingness to undergo TACE
• ECOG performance Status of 0-1
• The patient is expected to survive more than 3 months
• Laboratory values should meet all the following standards at the screening visit:
  • AST, ALP and ALT are ≤ 5x ULN. B. International Normalized Ratio (INR) ≤ 1.5 C. Prothrombin time \< 4 sec above upper limit of normal D. Absolute neutrophil count ≥ 1.5×10\^9/L; Hemoglobin ≥ 9 g/dL; platelet ≥ 50×10\^9/L.
  • Total bilirubin \< 2.5 mg/dL F. Serum creatinine \< 2 mg/dL
• With liver stiffness measurement \>7 kPa (assessed by FibroScan®) or \> 1.5 m/sec (assessed by acoustic radiation force impulse elastography (ARFI))