A Study of Standard Of Care Versus Radio Ablation in Early Stage HCC
A Randomized Controlled Trial of Standard Of Care Versus Radio Ablation in Early Stage Hepatocellular Carcinoma
University Health Network, Toronto
218 participants
May 11, 2026
INTERVENTIONAL
Conditions
Summary
This Phase II Prospective, parallel and open-label randomised control trial will investigate whether a radiotherapy technique (called SABR) can treat early stage liver cancer more effectively than current treatments which use heating probes directly inserted into the tumour or chemotherapy or radioactive particles injected into the blood supply of the tumour. Investigators hypothesize SABR will result in higher rates of freedom from local progression (FFLP) at 2 years compared to percutaneous thermal ablation ± TACE or transarterial therapies (TACE/TARE).The study will also look at other important outcomes such as progression free survival, overall survival, side effects, quality of life and people's experiences of their treatment.
Eligibility
Inclusion Criteria10
- \) Histological or radiological diagnosis of single, new HCC with largest diameter =8 cm (BCLC stage 0 or A).
- a) If prior history of HCC, the prior HCC must have been:
- Early stage, solitary HCC, =5 cm in size and,
- Have arisen within a different liver segment to the current HCC and,
- Treated with curative intent therapy >2 years prior with no evidence of active disease at the site.
- \) 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 resection and not planned for liver transplantation.
- \) Child-Pugh score =B7* with no or diuretic-controlled ascites
- \) ECOG performance status =2
- \) Platelets =50x109/L, Haemoglobin =80 g/L, Neutrophils =1.0x109/L, INR <1.8 (except if on therapeutic anticoagulation)
- \) 18 years of age or older and able to provide written consent
Exclusion Criteria7
- \) Presence of multifocal HCC, macrovascular invasion or extrahepatic disease
- \) Prior treatment for any HCC within last 2 years.
- \) Clinically evident ascites or hepatic encephalopathy
- \) Prior abdominal radiation therapy that would preclude the delivery of protocol defined SABR to the tumour.
- \) Untreated Hepatitis B or C
- \) Known additional invasive malignancy (excluding non-melanoma skin cancer) that is progressing or required treatment within the last 2 years.
- \) Pregnancy
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Interventions
SABR will be delivered in 3 or 5 outpatient treatment sessions (each 20 to 45 minutes in duration) spaced out over 1 to 2 weeks. The exact number of treatment sessions received, and the duration of each session depends on the size and location of the liver cancer.
Patients will receive standard of care treatment (SOC) as per their institution's local practice that will be administered by a doctor called an Interventional Radiologist. The therapies offered will depend on the size and location of the liver cancer and may include one or a combination of radiofrequency ablation (RFA) / microwave ablation (MWA) and/or transarterial chemoembolization (TACE) / transarterial radioembolisation (TARE).
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07628751