A Phase 2 interventional study of Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) in Hepatocellular Carcinoma, sponsored by University Health Network, Toronto. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-25.
Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Treatment
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Among 36 studies testing pembrolizumab in Carcinoma, Hepatocellular — 10 open to participants now, 12 under way, 1 of them phase 3. pembrolizumab · Carcinoma, Hepatocellular.
Among the 36 studies testing pembrolizumab in Carcinoma, Hepatocellular, this one is the 31st largest by enrollment, is one of 4 that started in 2018, is one of 19 in phase 2, and was the 11th registered.
3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.
Browse Carcinoma, Hepatocellular studies →10 of the 36 studies testing pembrolizumab in Carcinoma, Hepatocellular are open now, in 5 countries. Recruiting first, the newest first:
Diwakar Davar · Sites in United States
Ages 18+
National University Hospital, Singapore · Sites in Singapore
Ages 21–99
Second Affiliated Hospital of Guangzhou Medical University · Sites in China
Ages 18–75
Second Affiliated Hospital of Guangzhou Medical University · Sites in China
Ages 18–75
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Sites in China
Ages 18–90
By country, each count listing its studies:
pembrolizumab: first FDA approval 2014 (KEYTRUDA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 737 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 31 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, pembrolizumab is the treatment under test here. Read study by study →
36 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 23 · Phase 3 8
First in 2016; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 18 is below the median of 54 across 2,619 interventional studies indexed under Carcinoma, Hepatocellular.
Median enrollment 54 across the 36 interventional studies. Of the 21 that completed or were terminated, 17 (81%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 36 have an industry lead sponsor. The 10 most frequent:
University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 295 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
21 studies in Carcinoma, Hepatocellular by University Health Network, Toronto: 6 open now, 9 under way, 1 of them phase 3. Of 10 finished, 1 (10%) have results posted.
Among the 21 studies in Carcinoma, Hepatocellular by University Health Network, Toronto, this one is the 16th largest by enrollment of the 19 interventional ones that give a count, is one of 2 that started in 2018, is one of 8 in phase 2, and was the 10th registered.
University Health Network, Toronto’s Carcinoma, Hepatocellular studies by the year they started, since 2000.
1 of the studies testing pembrolizumab in Carcinoma, Hepatocellular that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04134559Allison O'Neill, MDCheckpoint Inhibition In Pediatric Hepatocellular Carcinoma | 2027-01-01 |
Add it to your calendar (.ics) → With an account.
Among the 36 studies testing pembrolizumab in Carcinoma, Hepatocellular, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among University Health Network, Toronto’s 21 in Carcinoma, Hepatocellular:
This tab as a report to print or save as PDF → With an account.
This is a phase 2 study whose purpose is to assess the efficacy of the combination of pembrolizumab and stereotactic body radiotherapy (SBRT) in patients with advanced hepatocellular carcinoma (HCC) who have experienced disease progression after treatment with sorafenib.
Pembrolizumab will be administered intravenously as a 30-minute infusion at a dose of 200 mg every 21 days, until disease progression or intolerable toxicity.
Stereotactic radiotherapy will commence on day 2 of the first cycle of pembrolizumab, and will be delivered in 5 fractions over 8-15 days in accordance with institutional protocol.
Subjects will be re-evaluated for response every 12 weeks. In addition to a baseline scan, confirmatory scans should also be obtained 4-8 weeks following initial documentation of objective response.
Response and progression will be evaluated in this study using both RECIST 1.1and (iRECIST) guideline (Seymor 2017).
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pembrolizumab, intravenously, at a dose of 200 mg, once every 3 weeks SBRT starting Day 2 of Cycle 1 of pembrolizumab treatment, given in 5 fractions over 10-15 days.
Drug: Pembrolizumab · Radiation: Stereotactic Body Radiotherapy (SBRT)
Pembrolizumab is a humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Also known as: KEYTRUDA
SBRT involves delivery of high doses of radiation therapy in smaller fractions
Overall Response Rate
To assess the systemic efficacy of combined SBRT and pembrolizumab in subjects with advanced HCC who have experienced disease progression after previous therapy, as measured by overall response rate (ORR).
Time frame: 3 years
Progression-free Survival
To determine the progression-free survival (PFS), in subjects receiving combination treatment with pembrolizumab and SBRT for advanced HCC who have experienced disease progression after sorafenib therapy.
Time frame: 3 years
Overall Survival Rate
To determine the overall survival (OS) in subjects receiving combination treatment with pembrolizumab and SBRT for advanced HCC who have experienced disease progression after sorafenib therapy.
Time frame: 3 years
18 patients of a planned 22 were enrolled
| Milestone | Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| Started | 18 |
| Completed | 17 |
| Not completed | 1 |
| Withdrew: Death | 1 |
To assess the systemic efficacy of combined SBRT and pembrolizumab in subjects with advanced HCC who have experienced disease progression after previous therapy, as measured by overall response rate (ORR).
| percentage of participants | Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| Overall Response Rate | 41 (18 to 67) |
To determine the progression-free survival (PFS), in subjects receiving combination treatment with pembrolizumab and SBRT for advanced HCC who have experienced disease progression after sorafenib therapy.
| years | Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| Progression-free Survival | 0.45 (0.233 to 0.825) |
To determine the overall survival (OS) in subjects receiving combination treatment with pembrolizumab and SBRT for advanced HCC who have experienced disease progression after sorafenib therapy.
| years | Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| Overall Survival Rate | 1.05 (0.475 to 2.15) |
Collected over 3 years, up to 36 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) | 3/18 (16.7%) | 14/18 (77.8%) | 18/18 (100%) |
| Event | Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| Ascites grade 3Gastrointestinal disorders | 4/18 |
| Blood bilirubin increased grade 2Investigations | 3/18 |
| Aspartate aminotransferase increased grade 3Investigations | 2/18 |
| Pneumonitis grade 3Respiratory, thoracic and mediastinal disorders | 2/18 |
| Alanine aminotransferase increased grade 3Investigations | 2/18 |
| Bone infection grade 3Infections and infestations | 2/18 |
| Blood bilirubin increased grade 1Investigations | 1/18 |
| Blood bilirubin increased grade 3Investigations | 1/18 |
| Acute kidney injury grade 3Renal and urinary disorders | 1/18 |
| Tumor lysis syndrome grade 3Metabolism and nutrition disorders | 1/18 |
| Event | Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| Aspartate aminotransferase increased grade 1Investigations | 12/18 |
| Alkaline phosphatase increased grade 1Investigations | 11/18 |
| Platelet count decreased grade 1Investigations | 11/18 |
| Alanine aminotransferase increased grade 1Investigations | 10/18 |
| Fatigue grade 1General disorders | 9/18 |
| Fatigue grade 2General disorders | 9/18 |
| Abdominal pain grade 1Gastrointestinal disorders | 9/18 |
| Lymphocyte count decreased grade 2Investigations | 9/18 |
| Lymphocyte count decreased grade 3Investigations | 9/18 |
| Anemia grade 1Blood and lymphatic system disorders | 9/18 |
Of the 18 patients included, 17 were evaluable for response.
| Age, Continuous(years) | Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| Median | 66.5 (45 to 78) |
| Sex: Female, Male(Participants) | Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| Female | 1 |
| Male | 17 |
| Race/Ethnicity, Customized(participants) | Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| Asian | 5 |
| White | 12 |
| Hispanic | 1 |
| Region of Enrollment(participants) | Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| Canada | 18 |
| Number of participants with history of liver disease(Participants) | Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| Hep B | 3 |
| Hep C | 6 |
| MASLD/Alcohol/other | 9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2018 to primary completion in Feb 2024, 72 months.
Results were first posted in Jul 2025, 1 year 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pembrolizumab
University Health Network, Toronto →