TheraSphere + Immunotherapy for Liver Cancer
(ROWAN Trial)
Trial Summary
What is the purpose of this trial?
The objective of the ROWAN clinical study is to assess the efficacy of local tumor control in HCC patients who receive TheraSphere followed by durvalumab and tremelimumab.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on antiviral treatment for hepatitis C, it should be stopped for at least 14 days before joining the study. Also, if you are using immunosuppressive medication, it should be stopped 14 days before the first dose of durvalumab, with some exceptions like certain steroids.
What data supports the effectiveness of the treatment TheraSphere Y-90 glass microsphere therapy for liver cancer?
Is TheraSphere treatment safe for liver cancer?
TheraSphere treatment, which uses tiny glass beads with a radioactive substance, has been studied for liver cancer and shows a safety profile with fewer stomach and lung-related side effects compared to similar treatments. However, it can still cause some liver-related issues and other side effects like nausea and fluid buildup in the abdomen.12456
How is the TheraSphere Y-90 treatment for liver cancer different from other treatments?
TheraSphere Y-90 treatment is unique because it involves injecting tiny glass beads containing a radioactive substance (yttrium-90) directly into the liver's blood vessels, allowing for targeted radiation therapy that minimizes damage to surrounding healthy tissue. This approach is particularly useful for liver tumors that cannot be surgically removed.12457
Research Team
Aiwu Ruth He, MD PhD
Principal Investigator
Georgetown University
Beau Toskich, MD
Principal Investigator
Mayo Clinic
Eligibility Criteria
Adults over 18 with Hepatocellular Carcinoma (HCC) who haven't had systemic HCC treatment, are ineligible for liver resection/ablation/transplantation, and have a tumor volume ≤35% of the liver. They must have adequate organ function, no severe hepatic vein invasion or extrahepatic metastases, and not be in another interventional study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
TheraSphere Treatment
TheraSphere is administered to patients before the initiation of Durvalumab and Tremelimumab
Durvalumab and Tremelimumab Treatment
Participants receive Tremelimumab plus Durvalumab once, followed by monthly Durvalumab administration
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Durvalumab
- TheraSphere Y-90 glass microsphere therapy
- Tremelimumab
TheraSphere Y-90 glass microsphere therapy is already approved in United States, European Union for the following indications:
- Unresectable hepatocellular carcinoma
- Hepatocellular carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Scientific Corporation
Lead Sponsor
Michael F. Mahoney
Boston Scientific Corporation
Chief Executive Officer since 2016
MBA from Wake Forest University, BBA in Finance from the University of Iowa
Kenneth Stein
Boston Scientific Corporation
Chief Medical Officer since 2020
MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology
Biocompatibles UK Ltd
Industry Sponsor