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Pembrolizumab for Liver Cancer
Study Summary
This trial will compare pembrolizumab to placebo to see if it can help prevent cancer from recurring in people who have had surgery or local ablation for HCC.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- I have recovered from any side effects of my cancer surgery or local treatment.I have or had lung inflammation that needed steroids.I have active tuberculosis.My scans show no cancer signs 4 weeks after surgery or local treatment.I have had bleeding from varices in my esophagus or stomach in the last 6 months.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.I have another cancer that is growing or was treated in the last 3 years.I have received treatment for liver cancer before, including experimental drugs.I have provided a tumor tissue sample during my screening.I have been treated with specific immune therapy drugs before.I've had a liver treatment that wasn't radiofrequency or microwave ablation.I have been diagnosed with brain function issues due to liver disease in the last 6 months.My liver is functioning well, with a score of 5 to 6.I am fully active or restricted in physically strenuous activity but can do light work.I am not pregnant or breastfeeding, and if I can have children, I use effective birth control or practice abstinence.I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.I have been diagnosed with liver cancer through imaging tests or biopsy.My organs are functioning well.I am currently being treated for an infection.I have both Hepatitis B and C.I have been treated for an autoimmune disease in the last 2 years.I have noticeable fluid buildup in my abdomen.I am not on any cancer treatments or strong steroids not approved in this study.I have not received a live vaccine in the last 30 days.I have received an organ or tissue transplant from another person.My hepatitis B is under control.
- Group 1: Pembrolizumab
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
Where are patients able to receive this experimental treatment?
"This study is enrolling at 16 different sites, including James Graham Brown Cancer Center (Site 0088) in Louisville, University of Cincinnati Medical Center (Site 0084) in Cincinnati, and Miami Valley Hospital South (Site 0093) in Centerville."
What is the total number of people who have signed up for this clinical trial?
"enrolment for this study is currently closed. The posting dates were from May 28th, 2019 to August 10th, 2022. If you're looking for other opportunities, 2689 trials are actively recruiting patients with carcinoma and 1000 trials require Pembrolizumab volunteers."
For what purpose is Pembrolizumab most commonly prescribed?
"Pembrolizumab is a common treatment for malignant neoplasms, and can also be used to treat unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."
Has Pembrolizumab received FDA authorization?
"Pembrolizumab has received a Phase 3 safety rating from our team at Power, meaning that while there is some efficacy data supporting its use, multiple rounds of testing have confirmed its safety."
Why was this clinical trial started in the first place?
"The primary outcome of this long-term study is Recurrence-Free Survival (RFS), which will be monitored over a period of six years. Additionally, the research team will assess Time to Deterioration (TTD) in the EORTC QLQ-HCC18 Scale Score, Change from Baseline in European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Health Utility Score, and Percentage of Participants who Experience an Adverse Event (AE)."
Pembrolizumab has been trialed before, correct? Could you tell us a bit about those other trials?
"Pembrolizumab is being researched in 1000 ongoing trials, with 122 of those in Phase 3. Pembrolizumab's clinical trials are hosted at 36021 locations worldwide, including Houston, Texas."
Are new participants currently being welcomed into this experiment?
"According to the latest information on clinicaltrials.gov, this study is not currently recruiting patients for participation. The trial was first posted on May 28th, 2019 and was edited most recently on August 10th, 2020. Despite this particular study not being open for recruitment, there are 3689 other studies that are actively looking for candidates right now."
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