Study Summary
This trial is testing an immunotherapy drug to see if it can treat pediatric liver cancer.
- Childhood Hepatocellular Carcinoma
- Fibrolamellar Carcinoma
- Liver Cancer
- Pediatric Liver Cancer
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: 2 Years
Trial Safety
Phase-Based Safety
Side Effects for
Awards & Highlights
Trial Design
1 Treatment Group
Pembrolizumab
1 of 1
Experimental Treatment
18 Total Participants · 1 Treatment Group
Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age No minimum age - 30 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- O'Neill, Allison F., Alanna J. Church, Antonio R. Perez-Atayde, Raja Shaikh, Karen J. Marcus, and Khashayar Vakili. 2021. “Fibrolamellar Carcinoma: An Entity All Its Own”. Current Problems in Cancer. Elsevier BV. doi:10.1016/j.currproblcancer.2021.100770.
- O'Neill, Allison F., Alanna J. Church, Antonio R. Perez-Atayde, Raja Shaikh, Karen J. Marcus, and Khashayar Vakili. 2021. “Fibrolamellar Carcinoma: An Entity All Its Own”. Current Problems in Cancer. Elsevier BV. doi:10.1016/j.currproblcancer.2021.100770.
- Short, Scott S., Zachary J. Kastenberg, Guo Wei, Alex Bondoc, Roshni Dasgupta, Greg M. Tiao, Erin Watters, et al.. 2022. “Histologic Type Predicts Disparate Outcomes in Pediatric Hepatocellular Neoplasms: A Pediatric Surgical Oncology Research Collaborative Study”. Cancer. Wiley. doi:10.1002/cncr.34256.
- Short SS, Kastenberg ZJ, Wei G, Bondoc A, Dasgupta R, Tiao GM, Watters E, Heaton TE, Lotakis D, La Quaglia MP, Murphy AJ, Davidoff AM, Mansfield SA, Langham MR, Lautz TB, Superina RA, Ott KC, Malek MM, Morgan KM, Kim ES, Zamora A, Lascano D, Roach J, Murphy JT, Rothstein DH, Vasudevan SA, Whitlock R, Lal DR, Hallis B, Butter A, Baertschiger RM, Lapidus-Krol E, Putra J, Tracy ER, Aldrink JH, Apfeld J, Le HD, Park KY, Rich BS, Glick RD, Fialkowski EA, Utria AF, Meyers RL, Riehle KJ. Histologic type predicts disparate outcomes in pediatric hepatocellular neoplasms: A Pediatric Surgical Oncology Research Collaborative study. Cancer. 2022 Jul 15;128(14):2786-2795. doi: 10.1002/cncr.34256. Epub 2022 May 13.
- Allison O'Neill 2020. "Checkpoint Inhibition In Pediatric Hepatocellular Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04134559.
Frequently Asked Questions
Might I be eligible to take part in this research project?
"This trial is seeking 18 participants who have hepatocellular carcinoma, and who were diagnosed with the condition in childhood. Those that wish to join should be between 0 and 30 years old." - Anonymous Online Contributor
What condition has seen the greatest improvement with Pembrolizumab?
"Pembrolizumab is an effective treatment for malignant neoplasms, unresectable melanoma, and microsatellite instability high." - Anonymous Online Contributor
At how many different locations is this trial currently taking place?
"Presently, there are 5 sites where this study is taking place: Baylor College of Medicine (Houston), Dana Farber Cancer Institute (Boston), Children's Hospital Boston (Cincinnati), and other locations." - Anonymous Online Contributor
What are Pembrolizumab's long-term effects on patients?
"Pembrolizumab has received a Phase 2 rating, meaning that while there is some evidence suggesting it is safe, there is no data to support its efficacy. Consequently, our team at Power have given it a safety score of 2." - Anonymous Online Contributor
How many people are allowed to enroll in this research project?
"In order to properly run this trial, 18 willing and eligible participants are required. These individuals can visit either of the two main study locations - Baylor College of Medicine in Houston or Dana-Farber Cancer Institute in Boston - though other recruitment sites may be available." - Anonymous Online Contributor
What other studies has Pembrolizumab been a part of in the past?
"City of Hope conducted the first clinical trial for pembrolizumab in 2010 and there are now 249 completed studies. Out of the 1000+ trials currently underway, many are being performed in Houston, Texas." - Anonymous Online Contributor
Are there any positions available for participants in this research project?
"Yes, this trial is still recruiting patients according to the most recent update on clinicaltrials.gov from September 8th, 2020. The study was first posted on November 1st, 2020." - Anonymous Online Contributor
Can patients below the age of 45 years old participate in this research?
"According to the inclusion criteria for this trial, qualified applicants are aged 0 to 30. There are currently 126 studies recruiting patients under 18 and 3813 for people over 65." - Anonymous Online Contributor