A Pilot Study of Pembrolizumab in Combination With Y90 Radioembolization in Subjects With Poor Prognosis Hepatocellular Carcinoma With Preserved Liver Function. HCRN: GI15-225
Study on the Effects of Investigational Medication with Radioembolization (a procedure using tiny radioactive beads to target cancer cells in the liver) for Liver Cancer
Brief description of study.
The purpose of this study is to test any good and bad effects of the study drug called pembrolizumab when it is given in combination with Y90 (TheraSphere?).
Detailed description of study
The purpose of this study is to evaluate the efficacy as well as the safety of combining pembrolizumab with Yttrium-90 radioembolization in subjects with poor prognosis hepatocellular carcinoma not eligible for liver transplant or surgical resection with well compensated liver function.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: hepatocellular carcinoma
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
Locally advanced HCC
No evidence of extrahepatic metastatic disease
Not eligible for surgical resection or liver transplant or have refused such procedures
Demonstrate adequate organ function
Exclusion Criteria
Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of study registration
Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to registration
Active autoimmune disease that has required systemic treatment in the past 2 years
Known history of active TB
Hypersensitivity to pembrolizumab or any of its excipients
Known history of HIV
Untreated active HBV
Dual infection with HBV/HCV or other hepatitis combinations at study entry
Known history of, or any evidence of active, non-infectious pneumonitis
History of organ transplantation including previous history of liver transplantation
Active infection requiring systemic therapy
Pregnant or breastfeeding
This study investigates the effects of an investigational medication combined with Yttrium-90 radioembolization for patients with advanced liver cancer, specifically hepatocellular carcinoma. This type of cancer affects the liver and is considered advanced when it cannot be treated with surgery or liver transplant. The study aims to understand how well this combination works and its safety for people with a poor prognosis but stable liver function.
Participants in the study will receive the investigational medication along with a treatment called Yttrium-90 radioembolization. This involves using tiny radioactive beads to target cancer cells in the liver. The study will monitor the effects of this combination treatment to gather information on its safety and effectiveness.
- Who can participate: Adults with advanced liver cancer, specifically hepatocellular carcinoma, who cannot have surgery or a liver transplant. Participants must not have extrahepatic metastatic disease and must have adequate organ function.
- Study details: Participants will receive an investigational medication combined with Yttrium-90 radioembolization. A placebo will not be used in this study.
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