A Phase 3 interventional study of Best Supportive Care (BSC) and Personalized ultrafractionated stereotactic adaptive radiation therapy (PULSAR) in Hepatocellular Carcinoma (HCC), sponsored by University Health Network, Toronto. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by University Health Network, Toronto · Phase 3, Interventional, and Treatment
This study evaluates whether Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy (PULSAR) improves overall survival compared with best supportive care (BSC).
The main questions this study aims to answer are: Does PULSAR improve overall survival compared with BSC? Does PULSAR delay deterioration in patient-reported outcomes and quality of life compared with BSC? Can adaptive radiotherapy delivered in ultrafractionated pulses improve the therapeutic ratio in patients with HCC and poor liver function? The study will compare PULSAR with BSC to evaluate differences in survival, disease control, liver function, and treatment-related toxicity. Participants randomized to the PULSAR arm will receive 24 Gy of radiation delivered in 3 fractions of 8 Gy each, administered every 3 weeks using adaptive stereotactic radiotherapy. Participants in the BSC arm will receive standard supportive care. All participants will undergo regular assessments of survival, disease progression, liver function, toxicities, and quality of life.
3,251 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.
This study's planned enrollment of 60 is close to the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →University Health Network, Toronto is the lead sponsor of 1,434 studies on the registry; 293 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Control
Other: Best Supportive Care (BSC)
Radiation: Personalized ultrafractionated stereotactic adaptive radiation therapy (PULSAR)
Palliative Care
SBRT pulses: 8Gy per pulse every 3 weeks up to 3 pulses
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death from any cause. OS will be estimated using the Kaplan-Meier method and compared between both arms using a log-rank test.
Time frame: 5 years
Progression Free Survival (PFS)
Progressive-free survival (PFS): time to progression or death
Time frame: From randomization until disease progression, death, or end of follow-up (up to [5 years]).
Lesion Progression
Progression and/or development of new (intrahepatic or extra-hepatic) lesions are defined by RECIST 1.1 criteria after comprehensive clinical examination and radiographic evaluation.
Time frame: 5 years
Liver Decompensation (Child Pugh)
Assessed using Child Pugh score where higher scores indicating worse liver function.
Time frame: 5 years
Liver Decompensation (mALBI)
Modified ALBI (mALBI) score where it ranges from Grade 1 (best liver function) to Grade 3 (worst liver function).
Time frame: 5 years
Physician-assessed toxicities
National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.6 where higher grades indicate greater severity of toxicity.
Time frame: 5 years
Patients-reported toxicities
Patient Reported Outcomes - Common Terminology Criteria of Adverse Events (PRO CTCAE) V.1 where higher scores indicate greater symptom burden and worse patient-reported toxicity.
Time frame: 5 years
Quality of life (QOL) (FACT-Hep)
Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep), with higher scores indicating better health-related quality of life.
Time frame: 5 years
Quality of life (QOL) (EQ-5D-5L)
EQ-5D-5L questionnaires, where higher scores indicate better health-related quality of life.
Time frame: 5 years
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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