NCT05883644 (SIERRA) is a Phase 3 clinical trial of Durvalumab in Advanced Hepatocellular Carcinoma, sponsored by AstraZeneca.

Who is sponsoring NCT05883644?

NCT05883644 is sponsored by AstraZeneca.

What drugs are being tested in NCT05883644?

Interventions in NCT05883644: Durvalumab, Tremelimumab.

What condition does NCT05883644 study?

NCT05883644 studies Advanced Hepatocellular Carcinoma.

Is NCT05883644 still recruiting?

NCT05883644 is currently active, enrolled. Last updated 18 February 2026.

Last reviewed 2026-02-18 · How we verify

NCT05883644: SIERRA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC)

Active, enrolled Phase 3 Last updated 18 February 2026

What this trial tests

Phase 3 trial testing Durvalumab in Advanced Hepatocellular Carcinoma in 111 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 June 2023

Primary endpoint
30 March 2026

30 September 2026

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	111
Start date	27 June 2023
Primary completion	30 March 2026
Estimated completion	30 September 2026
Sites	40 locations across France, Hong Kong, Italy, Japan, Germany, Vietnam, South Korea, Singapore

Drugs / interventions tested

Durvalumab — full drug profile →
Tremelimumab (TREMELIMUMAB) — full drug profile →

Conditions studied

Advanced Hepatocellular Carcinoma — all drugs for Advanced Hepatocellular Carcinoma →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, any sex, with Advanced Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Hepatocellular carcinoma: signaling pathways and therapeutic advances.
Zheng J, Wang S, Xia L, Sun Z, et al · · 2025 · cited 142× · PMID 39915447 · DOI 10.1038/s41392-024-02075-w
New Opportunities in the Systemic Treatment of Hepatocellular Carcinoma-Today and Tomorrow.
Becht R, Kiełbowski K, Wasilewicz MP. · · 2024 · cited 15× · PMID 38338736 · DOI 10.3390/ijms25031456
Evolution of Systemic Treatment for Hepatocellular Carcinoma: Changing Treatment Strategies and Concepts.
Moriguchi M, Kataoka S, Itoh Y. · · 2024 · cited 8× · PMID 39001448 · DOI 10.3390/cancers16132387
Early Safety Results from the Phase 3b SIERRA Study of Durvalumab and Tremelimumab as First-Line Treatment for Participants with Unresectable Hepatocellular Carcinoma and a Poor Prognosis.
Chan SL, Kudo M, Sangro B, Kelley RK, et al · · 2025 · cited 7× · PMID 41585428 · DOI 10.1159/000549955
Hepatocellular carcinoma systemic treatment update: From early to advanced stage.
Teng W, Wu TC, Lin SM. · · 2025 · cited 5× · PMID 39561966 · DOI 10.1016/j.bj.2024.100815
Insights in Molecular Therapies for Hepatocellular Carcinoma.
Heumann P, Albert A, Gülow K, Tümen D, et al · · 2024 · cited 5× · PMID 38791911 · DOI 10.3390/cancers16101831
Advances in Systemic Therapy for Hepatocellular Carcinoma and Future Prospects.
Sugimoto R, Kurokawa M, Tanaka Y, Senju T, et al · · 2025 · cited 3× · PMID 41002560 · DOI 10.3390/curroncol32090490
Review of immune therapy in HCC: Where are we now and what is the future?
Zanuso V, Pirozzi A, Tesini G, Rimassa L. · · 2024 · cited 1× · PMID 38881724 · DOI 10.1097/cld.0000000000000149

Verify or expand the search:

Other trials of Durvalumab

Trials testing the same drug.

NCT07507968 — TNT With FLOT/Durvalumab Plus Post-OP Durvalumab for Resectable Gastroesophageal Adenocarcinoma · Phase 2 · not yet recruiting
NCT07332351 — Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle · Phase 2 · not yet recruiting
NCT07339059 — Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Ce · Phase 2 · recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
NCT07459634 — A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC · Phase 2 · not yet recruiting

Other recruiting trials for Advanced Hepatocellular Carcinoma

Currently open trials in the same condition.

NCT07166406 — Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO- · Phase 3 · recruiting
NCT07174570 — Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer · Phase 2 · recruiting
NCT07227012 — Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatmen · Phase 1, PHASE2 · recruiting
NCT06811116 — Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metasta · Phase 1, PHASE2 · recruiting
NCT06789848 — Ligufalimab and Cadonilimab in Advanced Liver Cancers · Phase 2 · recruiting

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05883644 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 18 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05883644.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing