A randomised controlled trial of Standard Of Care versus RadioAblaTion in Early Stage HCC (The SOCRATES HCC Study)

ACTRN 12621001444875

Brief Summary

The SOCRATES HCC study aims to investigate whether a radiotherapy technique (called Stereotactic Ablative Body Radiotherapy or SABR) can improve outcomes for people with early stage liver cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs compared to other current treatments.

Intervention/Treatment

• Percutaneous ablation (either radiofrequency ablation (RFA)a minimally invasive procedure that uses heat to destroy abnormal tissue and/or cancer cells or microwave ablation (MWA) technique).
• Stereotactic ablative body therapy (SABR)/stereotactic body radiation therapya treatment that uses controlled doses of radiation to damage or kill cancer cells (SBRT).
• Transarterial therapies (such as transarterial chemoembolization (TACE) or transarterial radioembolisation (TARE)).

Inclusion Criteria:

1. Histological or radiological diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of single, new HCC with largest diameter =8 cm (BCLC stage 0 or A).
   • If prior history of HCC, the prior HCC must have been:
     1. Early stage, solitary HCC, =5 cm in size and,
     2. Have arisen within a different liver segment to the current HCC and,
     3. Treated with curative intent therapy >2 years prior with no evidence of activedisease at the site.
2. As per local multidisciplinary HCC meeting consensus patient is suitable for percutaneous thermal ablation and/or transarterial therapies and not suitable for or declined liver resectionsurgical removal of tissue or part/all of an organ and not planned for liver transplantation.
3. Child-Pugh score =B7* with no or diuretic-controlled ascitesa buildup of fluid in the abdomen.
4. ECOG performance status =2.
5. Plateletssmall disc-shaped blood cells that clump together to form clots to stop bleeding =50×109/L, Haemoglobin =80 g/L, Neutrophilsa type of white blood cell that act as a first responder to infections in the body =1.0×109/L, INR <1.8 (except if on therapeutic anticoagulation).
6. 18 years of age or older and able to provide written consent