Pembrolizumab for Liver Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Liver CancerPembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Liver Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 3 years

3 years
Overall response rate
Overall survival rate
Progression-free survival rate
Response rate in non-irradiated tumor lesions

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Pembrolizumab Second Course
100%Urinary tract infection
100%Parkinsonism
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Urinary tract infection with 100%, Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

1 Treatment Group

Pembrolizumab and Stereotactic Body Radiotherapy (SBRT)
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Pembrolizumab and Stereotactic Body Radiotherapy (SBRT)Experimental Group · 2 Interventions: Stereotactic Body Radiotherapy (SBRT), Pembrolizumab · Intervention Types: Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiotherapy (SBRT)
2016
Completed Phase 3
~580
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,382 Previous Clinical Trials
473,445 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

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
have a confirmed diagnosis of HCC and at least one lesion that can be measured.
The patient's current liver function meets Child Pugh Class A (5-6 points), and they do not have encephalopathy or ascites.
Must be at least 18 years old on the day you sign the informed consent form.
If smaller satellites of HCC or non-definite HCC need to be treated, they don't have to be encompassed within the SBRT volume, as long as it doesn't exceed normal tissue limits.
No more than 10 lesions can be treated at one time.
There is no evidence that the tumor has spread to the stomach, duodenum, small intestine, large intestine, or diaphragm.
is benign There is no single liver tumor that is benign if it is larger than 15 cm in diameter.
seen on preoperative CT There was no evidence of a common or main branch bile duct invasion on the preoperative CT scan.
are those patients who are able to understand the information contained in the consent form and who are willing to participate in the trial
The tumor should be less than twenty centimeters in diameter for treatment.