A Study of Standard Of Care Versus Radio Ablation in Early Stage HCC
SOCRATES HCC
A Randomized Controlled Trial of Standard Of Care Versus Radio Ablation in Early Stage Hepatocellular Carcinoma
2 other identifiers
interventional
218
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 11, 2026
CompletedFirst Submitted
Initial submission to the registry
May 13, 2026
CompletedFirst Posted
Study publicly available on registry
June 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2032
June 5, 2026
June 1, 2026
5.9 years
May 13, 2026
June 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Freedom from local progression (FFLP)
2 years
Secondary Outcomes (6)
Progression-free survival (PFS)
2 years
Overall survival (OS)
2 years
Safety and adverse events (CTCAE v5.0)
2 Years
Patient reported outcomes (EORTC QLQ-C30)
2 Years
Patient reported outcomes (QLQ-HCC18)
2 Years
- +1 more secondary outcomes
Study Arms (2)
Radiation Therapy
EXPERIMENTALStandard Of Care Treatment
OTHERInterventions
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.
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).
Eligibility Criteria
You may qualify if:
- \) 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.
- \) 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.
- \) Child-Pugh score =B7\* with no or diuretic-controlled ascites
- \) ECOG performance status =2
- \) Platelets =50x109/L, Haemoglobin =80 g/L, Neutrophils =1.0x109/L, INR \<1.8 (except if on therapeutic anticoagulation)
- \) 18 years of age or older and able to provide written consent
You may not qualify if:
- \) Presence of multifocal HCC, macrovascular invasion or extrahepatic disease
- \) Prior treatment for any HCC within last 2 years.
- \) Clinically evident ascites or hepatic encephalopathy
- \) Prior abdominal radiation therapy that would preclude the delivery of protocol defined SABR to the tumour.
- \) Untreated Hepatitis B or C
- \) Known additional invasive malignancy (excluding non-melanoma skin cancer) that is progressing or required treatment within the last 2 years.
- \) Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Trans Tasman Radiation Oncology Group
Waratah, Australia
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2026
First Posted
June 5, 2026
Study Start
May 11, 2026
Primary Completion (Estimated)
April 1, 2032
Study Completion (Estimated)
April 1, 2032
Last Updated
June 5, 2026
Record last verified: 2026-06