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Brief Title: Durvalumab and Tremelimumab in Combination With Either Y-90 SIRT or DEB-TACE for Intermediate Stage HCC
Official Title: A Phase II Study of Immunotherapy With Durvalumab (MEDI4736) and Tremelimumab in Combination With Either Y-90 SIRT or TACE for Intermediate Stage HCC With Pick-the-winner Design
Study ID: NCT04522544
Brief Summary: A Phase II study of immunotherapy with Durvalumab (MEDI4736) and Tremelimumab in combination with either Y-90 SIRT or DEB-TACE for intermediate stage HCC with pick-the-winner design
Detailed Description: The IMMUWIN phase II will test the safety and anti-tumor efficacy of the combination of Durvalumab and Tremelimumab with either Y-90 SIRT or DEB-TACE. Patients will be randomized into two experimental arms, one receiving SIRT + Durvalumab + Tremelimumab, the other arm receiving TACE + Durvalumab + Tremelimumab. It will be determined whether the combination of immunotherapy with SIRT or TACE is more promising.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Universitätsklinikum Bonn, Bonn, , Germany
Universitätsklinikum Essen, Essen, , Germany
Universitätsklinikum Freiburg, Freiburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitätsklinikum Jena, Jena, , Germany
Universitätsklinikum Köln, Köln, , Germany
Universtitätsklinikum Schleswig-Holstein, Lübeck, , Germany
Klinikum rechts der Isar der Technischen Universität München, München, , Germany
München Klinik Bogenhausen, München, , Germany
Name: Salah-Eddin Al-Batran, Prof. Dr.
Affiliation: Institut für Klinische Krebsforschung IKF GmbH
Role: STUDY_DIRECTOR
Name: Arndt Vogel, Prof. Dr.
Affiliation: Hannover Medical School
Role: PRINCIPAL_INVESTIGATOR