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Brief Title: Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC)
Official Title: A Phase IIIb Single Arm, Open-label, Multicentre Study of Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (SIERRA)
Study ID: NCT05883644
Brief Summary: This study will assess the safety and efficacy of Single Tremelimumab Regular Interval Durvalumab (STRIDE) as first-line therapy in participants with advanced unresectable HCC.
Detailed Description: This is a Phase IIIb, open-label, single arm, multicentre study to assess the safety and efficacy of STRIDE as first-line therapy in participants with advanced unresectable HCC who have one of the following: 1. Child-Pugh score B7 or B8 with a World Health Organisation Eastern Cooperative Oncology Group Performance Status (WHO/ECOG PS) of 0-1 at enrolment, or 2. Child-Pugh class A with a WHO/ECOG PS of 2 at enrolment, or 3. Child-Pugh class A with a WHO/ECOG PS of 0-1 and with evidence of chronic main trunk portal vein thrombosis at enrolment Participants must not have received any prior systemic therapy for HCC. Participants may have previously received locoregional therapy (LRT) but must no longer be suitable for additional LRT. Any local treatment needs to have been completed at least 4 weeks prior to initiation of treatment. The study consists of 4 periods: screening (Day-28 to Day -1), Treatment period, safety follow-up and survival follow-up.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, La Jolla, California, United States
Research Site, Shreveport, Louisiana, United States
Research Site, Detroit, Michigan, United States
Research Site, Bobigny, , France
Research Site, Clichy, , France
Research Site, Creteil, , France
Research Site, Lyon, , France
Research Site, Marseille, , France
Research Site, Rennes, , France
Research Site, Berlin, , Germany
Research Site, Frankfurt, , Germany
Research Site, Köln, , Germany
Research Site, Lübeck, , Germany
Research Site, Magdeburg, , Germany
Research Site, Mannheim, , Germany
Research Site, Hong Kong, , Hong Kong
Research Site, Shatin, , Hong Kong
Research Site, Milano, , Italy
Research Site, Napoli, , Italy
Research Site, Padova, , Italy
Research Site, Pisa, , Italy
Research Site, Rozzano, , Italy
Research Site, Turin, , Italy
Research Site, Chiba-shi, , Japan
Research Site, Chuo-ku, , Japan
Research Site, Kanazawa-shi, , Japan
Research Site, Kashiwa, , Japan
Research Site, Kyoto-shi, , Japan
Research Site, Matsuyama-city, , Japan
Research Site, Musashino-shi, , Japan
Research Site, Osakasayama-shi, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Gyeonggi-do, , Korea, Republic of
Research Site, Seongnam-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Singapore, , Singapore
Research Site, Singapore, , Singapore
Research Site, Singapore, , Singapore
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, Cordoba, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Pamplona, , Spain
Research Site, Hanoi, , Vietnam
Research Site, Ho Chi Minh, , Vietnam
Name: Stephen Chan, MD
Affiliation: Department of Clinical Oncology, Chinese University of Hong Kong
Role: PRINCIPAL_INVESTIGATOR
Name: Lorenza Rimassa, MD
Affiliation: Humanitas Cancer Centre, IRCCS Humanitas Research Hospital
Role: PRINCIPAL_INVESTIGATOR