SOCRATES HCC: A randomised controlled trial of Standard Of Care versus RadioAblaTion in Early Stage HepatoCellular Carcinoma

Liver cancer has the fastest rising incidence and mortality rate of any cancer in Australia. Less than 30% of patients with early stage disease are candidates for surgical resection or transplantation. Thermal ablation is an alternative curative intent therapy, however, it’s feasibility and effectiveness can be limited by tumour size and location. Up to 40-50% of patients are not suitable for surgery or thermal ablation and undergo “treatment stage migration” therapies such as TACE, with palliative intent. SABR has demonstrated high local control rates for small tumours but also in the treatment stage migration cohort, however, randomised evidence is lacking and uptake in guidelines and clinical practice is highly variable. SOCRATES will compare SABR to these other standard therapies for patients with early-stage HCC.

SOCRATES HCC aims to prospectively evaluate the efficacy, toxicity, health related quality of life and cost-effectiveness of stereotactic radiotherapy (SABR) compared to 1) thermal ablation and 2) transarterial therapies (if ineligible for ablation) in the management of early stage, inoperable, hepatocellular carcinoma.