A Trial on SBRT After Incomplete TAE or TACE Versus Exclusive TAE or TACE For Treatment of Inoperable HCC

A Randomised Phase III Trial on Stereotactic Body Radiotherapy (SBRT) After Incomplete Transcatheter Arterial Embolization (TAE) or Chemoembolization (TACE) Versus Exclusive TAE or TACE for Inoperable Hepatocellular Carcinoma (HCC)

The trial is a multicentre, prospective, randomised controlled, unblinded, parallel-group superiority trial of SBRT versus standard TAE/TACE for the curative treatment of inoperable HCC treated with a TAE/TACE incomplete cycle.

In this phase III study patients with inoperable HCC single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to stereotactic radiotherapy in 3 or 6 daily fractions or to a new cycle of TAE or TACE. A total of 80 patients (40 in each arm) will be recruited into the trial over a 2 years period and will be randomised on an equal basis to either SBRT or TAE/TACE. The follow-up period will be finished 1.5 years after the final patient is randomised.

Inclusion Criteria:

• Age >18 years
• Karnofsky index >70%
• Child-Turgotte-Pugh A or B liver score.
• An initial diagnosis of primary HCC or recurrence.
• A technically unresectable lesion or medically contraindicated surgery or a case in which surgery was declined.
• HCC (single nodule ≤ 5 cm or max 3 nodules ≤ 3 cm) diagnosed by histology or non-invasive EASL criteria
• Baseline CT or MRI and bone scan without evidence of radiologically definable major vascular invasion or extrahepatic disease
• Hb >10.5.0 g/%, WBC >3.000 cells/mm3, platelets >50.000 cells/mm3, bilirubin <2 mg/dl, aspartate and alanine aminotransferase levels <5 times upper normal limit, and prothrombin time-international normalized ratio ≤ 2;
• Serum creatinine <1.7 mg/dl
• Previously incomplete TAE or TACE with radiologically defined residual disease.
• Informed consent

Exclusion Criteria:

• Extrahepatic disease and refractory ascites.
• Previous abdominal radiation therapy (RT)
• Hemorrhage/bleeding event = Grade 3 within 4 weeks of enrollment in the study.
• Pregnant or breastfeeding patients.
• Patients with uncontrolled infections or HIV seropositive patients.
• Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study.