Recruiting

SABR

Sponsor:

University Health Network, Toronto

Code:

NCT07628751

Conditions

Early Hepatocellular Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Ablative Body Radiotherapy (SABR)

Therapies

Study Details

Brief 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.

Conditions

Early Hepatocellular Carcinoma

Study ID

NCT07628751

Start date

May 11, 2026

Status verified date

Jun, 2026

Completion date

Apr 1, 2032

Anticipated

Primary completion date

Apr 1, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

218 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Radiation Therapy

other: Standard Of Care Treatment

Interventions

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).

Primary outcome measure

  • Freedom from local progression (FFLP) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Michael Yan, MD MPH FRCPC DABR

(416) 946-2320Michael.Yan@uhn.ca

Locations

University Health Network - Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Michael Yan, MD MPH FRCPC DABR

Michael.Yan@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

  • SABR
  • Radiofrequency ablation
  • Transarterial chemoembolisation
  • Stereotactic Ablative Body Radiotherapy
  • RFA
  • TACE
  • TARE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-05.