Early Hepatocellular CarcinomaSOCRATES HCCNCT07628751
A Study of Standard Of Care Versus Radio Ablation in Early Stage HCC
A study testing Stereotactic Ablative Body Radiotherapy (SABR) and Therapies in people with Early Hepatocellular Carcinoma, run by University Health Network, Toronto at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Hepatocellular Carcinoma
- What is being tested?
- Stereotactic Ablative Body Radiotherapy (SABR) and Therapies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 11 May 2026to 1 Apr 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Australia1 site, 1 recruiting
- Recruiting
Trans Tasman Radiation Oncology Group
Waratah
Alan Wigg, Alan.wigg@sa.gov.au
Canada1 site, 1 recruiting
- Recruiting
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Michael Yan, MD MPH FRCPC DABR, Michael.Yan@uhn.ca
About this study
Official title: A Randomized Controlled Trial of Standard Of Care Versus Radio Ablation in Early Stage Hepatocellular Carcinoma
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.
Read the detailed description
The SOCRATES randomised controlled trial will assess the efficacy, toxicity, HRQoL profile and cost effectiveness of SABR compared to the current SOC treatment in patients with first diagnosis of unresectable, single nodule HCC. Participants will be placed into one of two groups based on the size of their tumour and whether thermal ablation is an appropriate treatment for them. The study will include about 218 participants in total. Participants will be randomly assigned to receive either SABR or the current standard of care. Standard care may include thermal ablation, transarterial chemoembolisation (TACE), or transarterial radioembolisation (TARE).
- Conditions
- Early Hepatocellular Carcinoma
- Being tested
- Stereotactic Ablative Body Radiotherapy (SABR), Therapies
- Keywords
- SABR, Radiofrequency ablation, Transarterial chemoembolisation, Stereotactic Ablative Body Radiotherapy, RFA, TACE, TARE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Ablative Body Radiotherapy (SABR)Radiation
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.
TherapiesRadiation
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 group | Role | What they receive |
|---|---|---|
| Radiation Therapy | Experimental | Not described Receives: Radiation: Stereotactic Ablative Body Radiotherapy (SABR) |
| Standard Of Care Treatment | Other | Not described Receives: Radiation: Therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from local progression (FFLP)
Measured: 2 years
Secondary outcomes (6)
Progression-free survival (PFS)
Measured: 2 years
Overall survival (OS)
Measured: 2 years
Safety and adverse events (CTCAE v5.0)
Measured: 2 Years
Patient reported outcomes (EORTC QLQ-C30)
The C30 is a 30-item instrument that evaluates HRQOL comprised of five functional scales (physical, cognitive, emotional, social, and role) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, anorexia, constipation, diarrhea, and financial), and a global QoL scale.
Responses are scored on a linear scale from 0 to 100. Higher scores on functioning/global health indicate a better, healthier state. Higher scores on symptom scales indicate a higher symptom burden or worse condition.
Measured: 2 Years
Patient reported outcomes (QLQ-HCC18)
QLQ-HCC18 is a questionnaire where patients report symptoms or problems on a scale of 1 (not much) to 4 (very much). Higher scores on symptom scales indicate a higher symptom burden or worse condition.
Measured: 2 Years
Cost-effectiveness analysis
Incremental cost per outcome
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start11 May 2026
- Primary completion1 Apr 2032 (estimated)
- Study completion1 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Trans Tasman Radiation Oncology Group, Australasian Gastro-Intestinal Trials Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628751
- Sponsor's protocol ID
- 25-5862
- Other IDs
- ACTRN12621001444875
- Acronym
- SOCRATES HCC
- Status last verified
- Jun 2026
- First submitted
- 13 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Standard Of Care Versus Radio Ablation in Early Stage Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07628751
- Acronym / sponsor ID
- SOCRATES HCC / 25-5862
- Conditions
- Early Hepatocellular Carcinoma
- Keywords
- SABR, Radiofrequency ablation, Transarterial chemoembolisation, Stereotactic Ablative Body Radiotherapy, RFA, TACE, TARE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Trans Tasman Radiation Oncology Group, Australasian Gastro-Intestinal Trials Group
- Study start
- 11 May 2026 (actual)
- Primary completion
- 1 Apr 2032 (estimated)
- Study completion
- 1 Apr 2032 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The SOCRATES randomised controlled trial will assess the efficacy, toxicity, HRQoL profile and cost effectiveness of SABR compared to the current SOC treatment in patients with first diagnosis of unresectable, single nodule HCC. Participants will be placed into one of two groups based on the size of their tumour and whether thermal ablation is an appropriate treatment for them. The study will include about 218 participants in total. Participants will be randomly assigned to receive either SABR or the current standard of care. Standard care may include thermal ablation, transarterial chemoembolisation (TACE), or transarterial radioembolisation (TARE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy | Experimental | Radiation: Stereotactic Ablative Body Radiotherapy (SABR) |
| Standard Of Care Treatment | Other | Radiation: Therapies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Radiation Therapy |
| TherapiesPatients 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). | Radiation | Standard Of Care Treatment |
Primary outcome
Freedom from local progression (FFLP)
Time frame: 2 years
6 secondary outcomes
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Safety and adverse events (CTCAE v5.0)
Time frame: 2 Years
Patient reported outcomes (EORTC QLQ-C30)
Time frame: 2 Years
Patient reported outcomes (QLQ-HCC18)
Time frame: 2 Years
Cost-effectiveness analysis
Time frame: 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Ablative Body Radiotherapy (SABR) and Therapies in people with Early Hepatocellular Carcinoma, run by University Health Network, Toronto at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Yan, MD MPH FRCPC DABR ((416) 946-2320, Michael.Yan@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from local progression (FFLP) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.