Study identifier:D419CR00030
ClinicalTrials.gov identifier:NCT05883644
EudraCT identifier:N/A
CTIS identifier:2022-502012-37-00
A Phase IIIb Single Arm, Open-label, Multicentre Study of Durvalumab and Tremelimumab as First Line Treatment in Participants with Advanced Hepatocellular Carcinoma (SIERRA)
Advanced Hepatocellular Carcinoma
Phase 3
No
Durvalumab, Tremelimumab
All
111
Interventional
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2025 by AstraZeneca
AstraZeneca
-
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.
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.
Location
Location
Madrid, Spain, 28040
Location
Hong Kong, Hong Kong, 0000
Location
Osakasayama-shi, Japan, 589-8511
Location
Bobigny, France, 93000
Location
Clichy, France, 92110
Location
Musashino-shi, Japan, 180-8610
Location
Turin, Italy, 10128
Location
Cordoba, Spain, 14004
Arms | Assigned Interventions |
---|---|
Experimental: Durvalumab plus Tremelimumab Participants will receive a single priming dose of Tremelimumab plus Durvalumab at Day 1 (Week 0), followed by Durvalumab monotherapy starting at Week 4 and continuing until clinical progression, confirmed RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or any intervention discontinuation criteria. | - |
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