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Checkpoint Inhibitor
Pembrolizumab + Radiotherapy for Liver Cancer
Phase 2
Waitlist Available
Led By Jennifer J. Knox, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a combination of two cancer treatments is more effective than one of the treatments alone in people with advanced liver cancer who have progressed after treatment with another drug.
Who is the study for?
Adults with advanced liver cancer (hepatocellular carcinoma) who have seen their disease progress after sorafenib treatment. They must be in good liver function (Child Pugh Class A), have no more than 10 treatable tumors within the liver, and no tumor larger than 15 cm. Participants need to provide a biopsy, not have had certain prior treatments or conditions like brain metastases or active hepatitis B and C together, and agree to use contraception if of childbearing potential.
What is being tested?
The trial is testing the effectiveness of combining pembrolizumab, an immunotherapy drug, with stereotactic body radiotherapy (SBRT) for treating advanced hepatocellular carcinoma. It's a phase 2 study where all participants receive both treatments to see how well they work together after previous sorafenib therapy has failed.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs including lungs and intestines, skin reactions, hormonal gland problems, fatigue, infusion reactions and can increase infection risk. SBRT might lead to fatigue, skin changes at the treated area, nausea or abdominal pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall response rate
Secondary study objectives
Overall survival rate
Progression-free survival rate
Response rate in non-irradiated tumor lesions
Side effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab and Stereotactic Body Radiotherapy (SBRT)Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiotherapy (SBRT)
2017
Completed Phase 3
~550
Pembrolizumab
2017
Completed Phase 3
~3150
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,523 Previous Clinical Trials
503,319 Total Patients Enrolled
3 Trials studying Liver Cancer
51 Patients Enrolled for Liver Cancer
Jennifer J. Knox, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
1 Previous Clinical Trials
332 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You experienced bleeding from the esophagus or stomach within the past 3 months before joining the study.You have received a specific type of radiation therapy called radioembolization or other selective internal radiotherapy treatment to the liver in the past.You are currently taking part in another clinical trial or have recently received experimental treatment or used an investigational device.You are allergic to pembrolizumab or any of its ingredients.You have a history of lung problems that are not caused by an infection.You have mental health or substance abuse problems that might make it difficult for you to follow the trial's rules and instructions.You have a history of serious heart problems that are currently active or unstable.You have a liver tumor that cannot be treated with a specific type of radiation therapy, or you have previously received radiation therapy in the upper abdomen in amounts that are higher than what is considered safe.The tumor has not spread directly to the stomach, duodenum, small bowel, large bowel, or diaphragm.You have already tried a different treatment for advanced liver cancer after sorafenib, or you have received radiation therapy in the area where the new treatment would be given.Your condition has gotten worse after being treated with sorafenib for at least 8 weeks, even with breaks or lower doses.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab and Stereotactic Body Radiotherapy (SBRT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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