Traditional (Traditional Chemoembolization) TACE Versus Microsphere TACE (PRECISION-IT)

Inclusion Criteria:

• Diagnosis of HCC: based on the Guidelines issued by AASLD (American Association for the Study of Liver Diseases) (latest diagnostic radiological imaging performed within 1 month from enrolment)
• HCC for which transplantation, surgical resection or percutaneous ablation are not indicated
• Absence of extrahepatic cancer involvement
• Absence of portal vein thrombosis, with the exception of thrombosis of a segment branch of the portal vein
• Child-Pugh class A or B
• Performance status: ECOG 0-2 (WHO)
• Target liver lesion measurable as per WHO modified EASL criteria
• Life expectancy of at least 3 months in absence of treatments.
• Prior surgical or locoregional ablation or TACE treatments are allowed for lesions other than the target lesion treated and monitored to define tumor response.
• The following laboratory parameters must be met:

Creatinine ≤ 1.50 mg/dL, Bilirubin ≤ 2.5 mg/dL, Albumin >= 30 g/L White blood cells >= 1.5 x 109/L, PLT >= 50 x 109/L, PT >= 50%

• Signature of informed consent obtained.

Exclusion Criteria:

• Infiltrative HCC
• Liver tumor is undefined, unmeasurable or not assessable
• Occlusive thrombosis of the common portal trunk or of a main branch (right or left).
• Ascites, F3-type varices.
• Contraindications to arteriography
• Hepatofugal portal flow
• Presence of hemodynamically relevant abnormalities of hepatic arterial structure, such as not to allow for a correct and safe delivery of microspheres.
• Prior TACE to the target lesions
• Presence of chronic or acute co-morbidities (to lungs, heart, kidneys or brain) because of which the patient is not eligible to receive the treatment foreseen by the protocol.
• Prior neoplasias in the 5 preceding years or concomitance of other neoplasias at enrolment, wtih the exception of cutaneous basal cell or squamous cells carcinoma or carcinoma in situ of the uterine cervix
• Presence of localized or systemic infections (with the exception of HIV infecton responsive to therapy).
• Pregnant women (women of child-bearing potential will have a pregnancy test done) and breastfeeding women;
• Known or suspect hypersensitivity to the investigational drug or to the investigational pharmacological class;
• Patients presenting with severe clinical conditions which in the opinion of the investigator contraindicate patient participation in the study;
• Use of investigational drugs in the last month prior to inclusion into the study
• Patients who are not capable of complying with the procedures established by the protocol and of signing the informed consent. In case of minors or incapacitated patients unable to release their informed consent to take part in the study, the consent must be released and signed also by the parents/guardian or by the legal representative. Minors or incapacitated patients must as well sign the informed consent to the best of their ability.