NCT07628751Recruiting
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
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 218 (estimated)
- First submitted
- 13 May 2026
- Start date
- 11 May 2026
- Primary completion date
- 1 Apr 2032
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07628751
What you commit to
- Study type: Interventional
- Planned participants: 218
- From 11 May 2026 to the primary completion date, 1 Apr 2032
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 2\) Prior treatment for any HCC within last 2 years.
- 4\) Prior abdominal radiation therapy that would preclude the delivery of protocol defined SABR to the tumour.
Other illness
- 1\) Presence of multifocal HCC, macrovascular invasion or extrahepatic disease
- 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.
Other
- 3\) Clinically evident ascites or hepatic encephalopathy
- 7\) Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Trans Tasman Radiation Oncology Group Coordinator of this site? Confirm its status | Waratah | Australia | Recruiting |
| University Health Network - Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.