Hepatocellular Carcinoma (HCC)Phase 3PULSAR-HCCNCT07895732
Personalized Adaptive Radiotherapy for Hepatocellular Carcinoma
A Phase 3 study testing Personalized ultrafractionated stereotactic adaptive radiation therapy (PULSAR) in people with Hepatocellular Carcinoma (HCC), run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Personalized ultrafractionated stereotactic adaptive radiation therapy (PULSAR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2026to 1 Dec 2031
- Phase
- Phase 3
- 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
- Diagnosis of HCC by at least 1 criterion: pathologically (histologically or cytologically) proven diagnosis of HCC, Radiographically proven diagnosis of HCC by multiphasic MRI and/or CT scan (arterial enhancement and delayed washout)
- One to five discrete intrahepatic parenchymal foci of HCC: Total maximal sum of intrahepatic parenchymal HCC tumors, as a single conglomerate, multiple lesions, or infiltrative HCC <10 cm in total summed diameter, HCC macrovascular invasion is permitted, Presence of extrahepatic metastatic disease is permitted, No direct primary tumor extension into the stomach, duodenum, small bowel, or large bowel.
- Patients must be Child-Pugh score B8-9
- In the investigator's opinion, patient is unsuitable for radical intent SBRT (i.e., ablative radiation dose over one to two weeks), or SBRT as bridge to liver transplant.
- Unsuitable for or refractory to standard local therapies, such as liver transplant, resection, radiofrequency ablation (RFA), or TACE.
- Unsuitable for TARE.
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- Unsuitable for, high risk for, or refractory to, standard systemic therapy.
- Must be ≥ 18 years of age.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Life expectancy > 3 months.
- Blood work obtained within 14 days prior to randomization as follows: Hemoglobin > 80 g/L (Note: The use of transfusion or other intervention to achieve Hgb ≥ 80g/L is acceptable), Platelets > 30 x 109/L, Absolute neutrophil count (ANC) > 1.0 x 109/L, INR < 3, Total Bilirubin < 4 x institutional UNL, AST or ALT < 6 x institutional ULN.
- Not pregnant
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Who cannot join
- Any previous RT to the abdomino-pelvic region that would result in significant overlap of RT volume for the current study.
- History of liver transplantation
- Individuals with severe, active co-morbidity including any of the following: Chronic obstructive pulmonary disease or other pulmonary illness requiring hospitalization within 30 days of study registration, Unstable angina and/or congestive heart failure requiring hospitalization within the 30 days of study registration, Acute myocardial infarction within 30 days of study registration, Diseases precluding RT (e.g., active scleroderma, lupus or inflammatory bowel disease)
- Participants must not be receiving any other standard anti-cancer therapy or experimental agent concurrently with PULSAR.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
Ali Hosni Abdalaty, 416-946-2124, ali.hosni@uhn.ca
About this study
Official title: Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy for Hepatocellular Carcinoma With Child Pugh B8-9 (PULSAR-HCC): Phase III Randomized Controlled Trial.
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.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Best Supportive Care (BSC), Personalized ultrafractionated stereotactic adaptive radiation therapy (PULSAR)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Supportive Care (BSC)Other
Palliative Care
Personalized ultrafractionated stereotactic adaptive radiation therapy (PULSAR)Radiation
SBRT pulses: 8Gy per pulse every 3 weeks up to 3 pulses
| Study group | Role | What they receive |
|---|---|---|
| Best Supportive Care | Other | Control Receives: Other: Best Supportive Care (BSC) |
| Radiation Therapy | Experimental | Not described Receives: Radiation: Personalized ultrafractionated stereotactic adaptive radiation therapy (PULSAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (8)
Progression Free Survival (PFS)
Progressive-free survival (PFS): time to progression or death
Measured: 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.
Measured: 5 years
Liver Decompensation (Child Pugh)
Assessed using Child Pugh score where higher scores indicating worse liver function.
Measured: 5 years
Liver Decompensation (mALBI)
Modified ALBI (mALBI) score where it ranges from Grade 1 (best liver function) to Grade 3 (worst liver function).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years
Quality of life (QOL) (EQ-5D-5L)
EQ-5D-5L questionnaires, where higher scores indicate better health-related quality of life.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2031 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895732
- Sponsor's protocol ID
- 26-5702
- Acronym
- PULSAR-HCC
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy for Hepatocellular Carcinoma With Child Pugh B8-9 (PULSAR-HCC): Phase III Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07895732
- Acronym / sponsor ID
- PULSAR-HCC / 26-5702
- Conditions
- Hepatocellular Carcinoma (HCC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2031 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 26 Oct 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best Supportive Care | Other | Other: Best Supportive Care (BSC)Control |
| Radiation Therapy | Experimental | Radiation: Personalized ultrafractionated stereotactic adaptive radiation therapy (PULSAR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of HCC by at least 1 criterion: pathologically (histologically or cytologically) proven diagnosis of HCC, Radiographically proven diagnosis of HCC by multiphasic MRI and/or CT scan (arterial enhancement and delayed washout)
- One to five discrete intrahepatic parenchymal foci of HCC: Total maximal sum of intrahepatic parenchymal HCC tumors, as a single conglomerate, multiple lesions, or infiltrative HCC <10 cm in total summed diameter, HCC macrovascular invasion is permitted, Presence of extrahepatic metastatic disease is permitted, No direct primary tumor extension into the stomach, duodenum, small bowel, or large bowel.
- Patients must be Child-Pugh score B8-9
- In the investigator's opinion, patient is unsuitable for radical intent SBRT (i.e., ablative radiation dose over one to two weeks), or SBRT as bridge to liver transplant.
- Unsuitable for or refractory to standard local therapies, such as liver transplant, resection, radiofrequency ablation (RFA), or TACE.
Key exclusion criteria (4 listed)
- Any previous RT to the abdomino-pelvic region that would result in significant overlap of RT volume for the current study.
- History of liver transplantation
- Individuals with severe, active co-morbidity including any of the following: Chronic obstructive pulmonary disease or other pulmonary illness requiring hospitalization within 30 days of study registration, Unstable angina and/or congestive heart failure requiring hospitalization within the 30 days of study registration, Acute myocardial infarction within 30 days of study registration, Diseases precluding RT (e.g., active scleroderma, lupus or inflammatory bowel disease)
- Participants must not be receiving any other standard anti-cancer therapy or experimental agent concurrently with PULSAR.
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 |
|---|---|---|
| Best Supportive Care (BSC)Palliative Care | Other | Best Supportive Care |
| Personalized ultrafractionated stereotactic adaptive radiation therapy (PULSAR)SBRT pulses: 8Gy per pulse every 3 weeks up to 3 pulses | Radiation | Radiation Therapy |
Primary outcome
Overall Survival (OS)
Time frame: 5 years
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.
8 secondary outcomes
Progression Free Survival (PFS)
Time frame: From randomization until disease progression, death, or end of follow-up (up to [5 years]).
Lesion Progression
Time frame: 5 years
Liver Decompensation (Child Pugh)
Time frame: 5 years
Liver Decompensation (mALBI)
Time frame: 5 years
Physician-assessed toxicities
Time frame: 5 years
Patients-reported toxicities
Time frame: 5 years
Quality of life (QOL) (FACT-Hep)
Time frame: 5 years
Quality of life (QOL) (EQ-5D-5L)
Time frame: 5 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 26 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Personalized ultrafractionated stereotactic adaptive radiation therapy (PULSAR) in people with Hepatocellular Carcinoma (HCC), run by University Health Network, Toronto at 1 site in Canada.
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 13 inclusion and 4 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 5 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 26 Oct 2026.