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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate
Secondary outcome measures
Overall survival rate
Progression-free survival rate
Response rate in non-irradiated tumor lesions
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
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
Pembrolizumab
2017
Completed Phase 2
~2010
Stereotactic Body Radiotherapy (SBRT)
2016
Completed Phase 3
~580
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,483 Previous Clinical Trials
486,503 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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