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RECRUITING
NCT07628751
NA

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

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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.

Official title: A Randomized Controlled Trial of Standard Of Care Versus Radio Ablation in Early Stage Hepatocellular Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

218

Start Date

2026-05-11

Completion Date

2032-04-01

Last Updated

2026-06-05

Healthy Volunteers

No

Interventions

RADIATION

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.

RADIATION

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).

Locations (2)

Trans Tasman Radiation Oncology Group

Waratah, Australia

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada