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Checkpoint Inhibitor

Pembrolizumab + Radiotherapy for Liver Cancer

Phase 2
Recruiting
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
No evidence of direct tumor extension into stomach, duodenum, small bowel, large bowel or diaphragm
Have demonstrated disease progression, after previous treatment with sorafenib for advanced or metastatic disease, lasting a minimum of 8 week period, allowing for appropriate interruptions and dose reductions
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
The tumor has not spread directly to the stomach, duodenum, small bowel, large bowel, or diaphragm.
Select...
Your condition has gotten worse after being treated with sorafenib for at least 8 weeks, even with breaks or lower doses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

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 • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
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
~1950
Stereotactic Body Radiotherapy (SBRT)
2016
Completed Phase 3
~580

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,456 Previous Clinical Trials
482,769 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

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03316872 — Phase 2
Liver Cancer Research Study Groups: Pembrolizumab and Stereotactic Body Radiotherapy (SBRT)
Liver Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03316872 — Phase 2
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03316872 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what maladies is Pembrolizumab typically applied as a treatment?

"Pembrolizumab is typically endorsed to treat malignant neoplasms, yet it can also be utilized to manage unresectable melanoma, microsatellite instability-high conditions and the advancement of diseases after chemotherapy."

Answered by AI

Does taking Pembrolizumab pose a substantial risk to patients?

"Despite not yet having any efficacy data, the safety of Pembrolizumab was estimated to be a 2 on our team's scale, due to Phase 2 trial results."

Answered by AI

How many participants are currently engaged in the clinical experiment?

"Affirmative. Clinicaltrials.gov records indicate that this experiment, initiated on February 15th 2018, is currently recruiting participants. 30 individuals are being sought after from a single medical centre."

Answered by AI

Does this experiment accept new participants at the current time?

"This clinical trial is presently enrolling patients as per information hosted on clinicaltrials.gov, with the initial post date of February 15th 2018 and last update occurring December 31st 2021."

Answered by AI

Have researchers conducted any previous investigations related to Pembrolizumab?

"Currently, there are 961 medically-approved studies into the efficacy of Pembrolizumab with 122 having progressed to Phase 3. Though Houston is a major site for these trials, one can find 35727 different locations conducting clinical research on this drug."

Answered by AI
~4 spots leftby Mar 2025