SABR vs standard care for early liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase II randomized trial comparing SABR to the current standard of care for patients with a first diagnosis of unresectable, single-node HCC. Eligible participants are assigned based on tumor size and suitability for percutaneous ablation or arterial therapies, and about 218 people will be enrolled. Outcomes include local tumor control at 2 years, progression-free and overall survival, side effects, quality of life, and treatment experiences. The study will also evaluate cost effectiveness and toxicity, to determine SABR’s overall value relative to standard treatment options.

Why it matters

Who can join: the full rules

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

Where it's running

• Trans Tasman Radiation Oncology Group
  Waratah, Australia Recruiting
• University Health Network - Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Michael Yan, MD MPH FRCPC DABR
• Email: Michael.Yan@uhn.ca
• Phone: (416) 946-2320

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.