Evidence map›Paper›PMID 40384092›Full record

Trial reportHepatology (Baltimore, Md.)2026

Immune-mediated adverse events and overall survival with tremelimumab plus durvalumab and durvalumab monotherapy in unresectable HCC: HIMALAYA phase III randomized clinical trial.

George Lau, Bruno Sangro, Ann-Lii Cheng, Masatoshi Kudo, Robin Kate Kelley, Won Young Tak, Antonio Gasbarrini, Maria Reig, Ho Yeong Lim, David Tougeron and 19 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07774247 (A Multicenter, Phase II Study to Evaluate the Safety and Efficacy of Atezolizumab, Bevacizumab, and Tocilizumab in Patients With Advanced Hepatocellular Carcinoma), which is not on this map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07774247 phase2not yet recruitingnot on this map

A Multicenter, Phase II Study to Evaluate the Safety and Efficacy of Atezolizumab, Bevacizumab, and Tocilizumab in Patients With Advanced Hepatocellular Carcinoma

TypeinterventionalSponsorCHA UniversityRan2026 to 2029Enrolled51ConditionsHepatocellular Carcinoma (HCC)ArmsAtezolizumab, Bevacizumab, Tocilizumab
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Article
  8. Observational
  9. Durvalumab-Tremelimumab in Advanced Hepatocellular Carcinoma: Real-World Data From the LOR-HCC (Lombardy Real-World HCC Group).Liver international : official journal of the International Association for the Study of the Liver · 2026
    Article
  10. Article
  11. Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors.

George LauHumanity and Health Clinical Trial Center, Humanity and Health Medical Group, Hong Kong Special Administrative Region, China.
Bruno SangroLiver Unit and HPB Oncology Area, Clínica Universidad de Navarra and CIBEREHD, Pamplona, Spain.
Ann-Lii ChengDepartment of Oncology, National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei, Taiwan.
Masatoshi KudoDepartment of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.
Robin Kate KelleyHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, California, USA.
Won Young TakDepartment of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.
Antonio GasbarriniFondazione Policlinico Universitario Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
Maria ReigBarcelona Clinic Liver Cancer (BCLC), Liver Unit, Hospital Clinic de Barcelona, IDIBAPS, CIBEREHD, University of Barcelona, Barcelona, Spain.
Ho Yeong LimSamsung Medical Center, Sungkyunkwan University, Seoul, Republic of Korea.
David TougeronDepartment of Gastroenterology and Hepatology, Poitiers University Hospital, Poitiers, France.
Enrico N De ToniDepartment of Medicine II, University Hospital, LMU Munich, Munich, Germany.ORCID 0000-0002-8101-8207
Vincent C TamDepartment of Oncology, Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada.
Kabir ModyDepartment of Medicine, Division of Hematology/Oncology, Mayo Clinic, Jacksonville, Florida, USA.
Jun GongDepartment of Medicine, Division of Hematology and Oncology, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Oxana V CryslerRogel Cancer Center, University of Michigan, Ann Arbor, Michigan, USA.
Wattana SukeepaisarnjaroenDepartment of Medicine, Faculty of Medicine, Khon Kaen University, Srinagarind Hospital, Khon Kaen, Thailand.
Oleg LipatovDepartment of Oncology, Republican Clinical Oncology Dispensary, Ufa, Russia.
Manabu MorimotoHepatobiliary and Pancreatic Oncology, Kanagawa Cancer Center, Yokohama, Japan.
Isabelle ArchambeaudHépato-Gastro-Entérologie et Assistance Nutritionnelle, Institut des Maladies de l'Appareil Digestif (IMAD), Nantes Université, CHU Nantes, Nantes, France.
Valentina BurgioDepartment of Medical Oncology, Vita-Salute University, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Le Thi Tuyet PhuongPeople's Hospital 115, Ho Chi Minh City, Vietnam.
Yee ChaoDepartment of Oncology, Division of Medical Oncology, Center for Immuno-oncology, Taipei Veterans General Hospital, Taipei, Taiwan.
Jean-Marie PeronHepatology Unit, Rangueil University Hospital, Toulouse, France.
Marie-Luise BerresClinic of Gastroenterology, Metabolic Diseases and Internal Medicine Intensive Care, University Hospital RWTH Aachen, Aachen, Germany.ORCID 0000-0002-8009-948
Yoo-Joung KoSt Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.
Di RanAstraZeneca, Gaithersburg, Maryland, USA.
Mallory MakowskyAstraZeneca, Gaithersburg, Maryland, USA.
Alejandra NegroAstraZeneca, Gaithersburg, Maryland, USA.
Ghassan K Abou-AlfaDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

BACKGROUND AND

aimsIn the global phase III HIMALAYA study in unresectable HCC, STRIDE significantly improved overall survival (OS) versus sorafenib; durvalumab was noninferior to sorafenib. Immune checkpoint inhibitor studies have shown an association between the occurrence of immune-mediated adverse events (imAEs) and improved OS. We assessed potential associations between the occurrence of imAEs and OS, and temporal patterns of imAEs, in HIMALAYA. APPROACH AND

resultsOS in participants who did and did not experience imAEs and the frequency and timing of imAEs were assessed for STRIDE and durvalumab in the safety analysis set of HIMALAYA. imAEs occurred in 139/388 (35.8%) and 64/388 (16.5%) participants with STRIDE and durvalumab, respectively; most were low grade. OS HRs (95% CI) in participants who experienced imAEs versus those who did not were 0.73 (0.56-0.95) for STRIDE and 1.14 (0.82-1.57) for durvalumab. The 36-month OS rate (95% CI) for STRIDE was 36.2% (28.1-46.7) and 27.7% (22.4-34.2) in participants who did and did not experience imAEs, respectively. The most common imAE category with STRIDE was endocrine events (16.5%). Most imAEs occurred ≤3 months after treatment initiation.

conclusionsParticipants who experienced imAEs with STRIDE had a numerical improvement in OS versus those who did not, which was not observed for durvalumab. Long-term OS with STRIDE was observed regardless of imAEs. Most imAEs were low grade, manageable, and occurred in the first 3 months after treatment initiation. Results continue to support the benefits of STRIDE in a diverse population that reflects unresectable HCC globally.

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularLiver NeoplasmsAdultAgedFemaleHumansImmune Checkpoint InhibitorsMaleMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizeddurvalumabImmune Checkpoint Inhibitorstremelimumabanti-cytotoxic T-lymphocyte–associated antigen 4anti–programmed cell death ligand-1immune checkpoint inhibitorssafetysurvival

Identifiers

PMID40384092
PMCPMC12904228

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.