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Brief Title: TheraSphere With Durvalumab and Tremelimumab for HCC
Official Title: An Open-Label, Prospective, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of TheraSphere™ Followed by Durvalumab (Imfinzi®) With Tremelimumab (Imjudo®) for Hepatocellular Carcinoma (HCC)
Study ID: NCT05063565
Brief Summary: 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.
Detailed Description: A global open-label, prospective, multi-center Phase II trial designed to assess the safety and efficacy of TheraSphere administered before initiation of Durvalumab with Tremelimumab in HCC patients who are not a candidate for resection, thermal ablation or liver transplant at the time of study entry.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Arizona- Banner Health, Tucson, Arizona, United States
University of California San Diego, San Diego, California, United States
University of California San Francisco, San Francisco, California, United States
Georgetown University, Washington, District of Columbia, United States
MedStar Washington Hospital Center, Washington, District of Columbia, United States
Mayo Clinic, Jacksonville, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Chicago Hospital, Chicago, Illinois, United States
Indiana University, Indianapolis, Indiana, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
University of Minnesota, Minneapolis, Minnesota, United States
Washington University (Barnes-Jewish Hospital), Saint Louis, Missouri, United States
NYU Langone Health, New York, New York, United States
Intermountain Health, Salt Lake City, Utah, United States
CHU Nantes, Rennes, Cedex, France
CHU Grenoble, Grenoble, Isere, France
CHU Angers - Hôpital Hôtel Dieu, Angers Cedex 9, , France
CHU de Bordeaux - Hôpital Haut-Lévêque, Clermont-Ferrand, , France
CHU Montpellier, Montpellier, , France
CHU Angers - Hôpital Hôtel Dieu, Nantes, , France
CRLCC Eugene Marquis, Rennes, , France
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
Clinica Universidad de Navarra, Pamplona, Navarre, Spain
Clinica Universidad de Navarra, Madrid, , Spain
Hospital Gregorio Maranon, Madrid, , Spain
Hospital Universitario Virgen de las Nieves, Madrid, , Spain
Hospital. Ramon Y Cajal, Madrid, , Spain
Name: Beau Toskich, MD
Affiliation: Mayo Clinic
Role: PRINCIPAL_INVESTIGATOR
Name: Aiwu Ruth He, MD PhD
Affiliation: Georgetown University
Role: PRINCIPAL_INVESTIGATOR