A Study of Standard Of Care Versus Radio Ablation in Early Stage HCC

NCT07628751 · tracked via the Priya Life Science Australia tracker

Sponsor

University Health Network, Toronto

Phase

Not applicable

Started

2026-05-11

Last updated

2026-06-05

Condition(s) studied

Early Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

Stereotactic Ablative Body Radiotherapy (SABR)Therapies

Stereotactic Ablative Body Radiotherapy (SABR): 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.

Therapies: 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).

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1\) 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. * 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 resection and not planned for liver transplantation. * 3\) Child-Pugh score =B7\* with no or diuretic-controlled ascites * 4\) ECOG performance status =2 * 5\) Platelets =50x109/L, Haemoglobin =80 g/L, Neutrophils =1.0x109/L, INR \<1.8 (except if on therapeutic anticoagulation) * 6\) 18 years of age or older and able to provide written consent Exclusion Criteria: * 1\) Presence of multifocal HCC, macrovascular invasion or extrahepatic disease * 2\) Prior treatment for any HCC within last 2 years. * 3\) Clinically evident ascites or hepatic encephalopathy * 4\) Prior abdominal radiation therapy that would preclude the delivery of protocol defined SABR to the tumour. * 5\) Untreated Hepatitis B or C * 6\) Known additional invasive malignancy (excluding non-melanoma skin cancer) that is progressing or required treatment within the last 2 years. * 7\) Pregnancy

Primary outcome measure(s)

Freedom from local progression (FFLP) — 2 years

Trial sites (2)

Facility	City	Region	Status
Trans Tasman Radiation Oncology Group	Waratah	Australia	Recruiting
University Health Network - Princess Margaret Cancer Centre	Toronto	Ontario	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07628751 on ClinicalTrials.gov ↗ ← All trials in Australia