SOCRATES HCC

Protocol Title

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

Purpose of study

Hepatocellular carcinoma (HCC) has the fastest rising incidence rate of any cancer. For early-stage HCC, curative surgical therapies such as liver resection and liver transplantation are recommended to achieve the best survival outcomes. More than 75% of patients with early-stage HCC are not suitable for either surgical resection or liver transplantation because of age, underlying severity of liver disease, clinically significant portal hypertension or significant comorbidities.

Percutaneous ablation (PA) is the current standard of care (SOC) and curative therapy in this group of early-stage HCC patients with tumours <3cm deemed not eligible for surgery. PA has limitations with respect to tumour location and size. For patients not suitable for PA, the current SOC options include palliative transarterial therapies such as transarterial chemoembolisation (TACE), transarterial radioembolisation (TARE), systemic therapy or best supportive care.

However, in order to improve the outcomes for patients with HCC, Stereotactic body radiotherapy (SBRT), a non-invasive specialised method of external beam radiotherapy has shown to improve local tumour control (LTC) and reduce the risk of receiving non-curative treatment.

The aim of this study is to evaluate the efficacy of Stereotactic body radiotherapy (SBRT) compared to standard of care for the treatment of inoperable, early stage HCC (single nodule HCC ≤5 cm).

Eligibility Criteria

Inclusion Criteria
• Histological or radiological diagnosis of primary, localised HCC, unresectable or ineligible for liver resection or transplant as per HCC multidisciplinary meeting consensus recommendation.
• Single HCC with the largest diameter ≤5 cm (BCLC stage 0 or A)
• No prior treatment of HCC (resection, loco-regional or systemic therapy).
• Child-Pugh score ≤B7 with no or diuretic-controlled ascites
• ECOG ≤2
• Suitable for PA or transarterial therapies

Exclusion Criteria
• Presence of vascular invasion or extrahepatic disease
• Clinically evident ascites
• Prior abdominal or liver directed radiation therapy
• Untreated Hepatitis B infection
• Pregnancy

Contact Email

SOCRATES_HCC@trog.com.au

Principal investigator

Professor Alan Wigg
A/Professor David Pryor

Detailed information available

Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) please click here.

Funding

MRFF funding