Evidence map›Paper›PMID 39089633›Full record

Trial reportJournal of hepatology2025

Outcomes in the Asian subgroup of the phase III randomised HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma.

George Lau, Ghassan K Abou-Alfa, Ann-Lii Cheng, Wattana Sukeepaisarnjaroen, Tu Van Dao, Yoon Koo Kang, Satheesh Chiradoni Thungappa, Masatoshi Kudo, Bruno Sangro, Robin Kate Kelley and 15 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of hepatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03298451 (A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma), which is not on this map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing 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.

NCT03298451 phase3active not recruitingnot on this map

A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

TypeinterventionalSponsorAstraZenecaRan2017 to 2027Enrolled1,324ConditionsHepatocellular CarcinomaArmsDurvalumab, Tremelimumab (Regimen 1), Tremelimumab (Regimen 2), Sorafenib, Durvalumab (Regimen 1)
3 · Its place in the literature

Who cites it

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

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors.

George LauHumanity and Health Clinical Trial Center, Humanity and Health Medical Group, Hong Kong Special Administrative Region, China.
Ghassan K Abou-AlfaDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA; Weill Medical College, Cornell University, New York, New York, USA. Electronic address: abou-alg@MSKCC.ORG.
Ann-Lii ChengNational Taiwan University Cancer Center, National Taiwan University Hospital, Taipei, Taiwan.
Wattana SukeepaisarnjaroenDepartment of Medicine, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand.
Tu Van DaoCancer Research and Clinical Trials Center, Department of Optimal Therapy, National Cancer Hospital, Hanoi, Vietnam.
Yoon Koo KangDepartment of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
Satheesh Chiradoni ThungappaSri Venkateshwara Hospital, Bangalore, India.
Masatoshi KudoDepartment of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.
Bruno SangroLiver Unit and HPB Oncology Area, Cancer Center Clínica Universidad de Navarra and CIBEREHD, Pamplona, Spain.
Robin Kate KelleyHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, California, USA.
Junji FuruseDepartment of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan.
Joong-Won ParkDepartment of Gastroenterology and Hepatology, Center for Liver and Pancreatobiliary Cancer, National Cancer Center, Goyang, Republic of Korea.
Patrapim SunpaweravongDepartment of Internal Medicine, Prince of Songkla University Hospital, Songkhla, Thailand.
Angelica FasoloFondazione Michelangelo, Milan, Italy.
Thomas YauQueen Mary Hospital, Pok Fu Lam, Hong Kong Special Administrative Region, China.
Tomokazu KawaokaDepartment of Gastroenterology and Metabolism, Hiroshima University, Hiroshima, Japan.
Sergio AzevedoDepartment of Internal Medicine, UPCO-Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Maria ReigBarcelona Clinic Liver Cancer (BCLC), Liver Oncology Unit, Liver Unit, Hospital Clinic de Barcelona, IDIBAPS, CIBEREHD, University of Barcelona, Barcelona, Spain.
Eric AssenatDepartment of Medical Oncology, Saint Eloi Hospital, Montpellier University, Montpellier, France.
Mark YarchoanDepartment of Oncology, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, USA.
Aiwu Ruth HeDivision of Hematology and Oncology, Lombardi Comprehensive Cancer Center, Georgetown University, Washington, District of Columbia, USA.
Mallory MakowskyAstraZeneca, Gaithersburg, Maryland, USA.
Charu GuptaAstraZeneca, Wilmington, Delaware, USA.
Alejandra NegroAstraZeneca, Gaithersburg, Maryland, USA.
Stephen L ChanState Key Laboratory of Translational Oncology, Department of Clinical Oncology, Sir Yue-Kong Pao Center for Cancer, The Chinese University of Hong Kong, Hong Kong Special Administrative Region, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND &

aimsIn the global, phase III HIMALAYA study in unresectable hepatocellular carcinoma (uHCC), STRIDE (Single Tremelimumab Regular Interval Durvalumab) improved overall survival (OS) vs. sorafenib; durvalumab was non-inferior to sorafenib. HBV is the predominant HCC aetiology in most of Asia vs. HCV or non-viral aetiologies in Western countries and Japan. This analysis evaluated safety and efficacy outcomes for STRIDE and durvalumab monotherapy vs. sorafenib, in HIMALAYA participants enrolled in Asia, excluding Japan.

methodsIn HIMALAYA, participants were randomised to STRIDE, durvalumab, or sorafenib. The Asian subgroup in this analysis included participants enrolled in Hong Kong, India, South Korea, Taiwan, Thailand, and Vietnam. OS, objective response rate (ORR; per RECIST, version 1.1), and safety were assessed in the Asian subgroup and in an exploratory subgroup of participants in Hong Kong and Taiwan.

resultsThe Asian subgroup included 479 participants randomised to STRIDE (n = 156), durvalumab (n = 167), or sorafenib (n = 156). OS was improved for STRIDE vs. sorafenib (hazard ratio [HR] 0.68; 95% CI 0.52-0.89). The OS HR for durvalumab vs. sorafenib was 0.83 (95% CI 0.64-1.06). In Hong Kong and Taiwan (n = 141), OS HRs for STRIDE vs. sorafenib and durvalumab vs. sorafenib were 0.44 (95% CI 0.26-0.77) and 0.64 (95% CI 0.37-1.08), respectively. In the Asian subgroup, ORR (including unconfirmed responses) was numerically higher for STRIDE (28.2%) and durvalumab (18.6%) vs. sorafenib (9.0%), and Grade 3/4 treatment-related adverse events were numerically lower for STRIDE (19.9%) and durvalumab (13.3%) vs. sorafenib (30.5%).

conclusionsSTRIDE improved outcomes vs. sorafenib in the Asian subgroup. These results support the benefits of STRIDE for participants with uHCC globally, including in the Asia-Pacific region. CLINICAL TRIAL NUMBER: NCT03298451. IMPACT AND IMPLICATIONS: The global, phase III HIMALAYA study found that the STRIDE (Single Tremelimumab Regular Interval Durvalumab) regimen improved overall survival (OS), including long-term OS vs. sorafenib, and that durvalumab monotherapy was non-inferior to sorafenib in participants with unresectable hepatocellular carcinoma (uHCC). However, there are differences in the aetiology and clinical practices related to HCC in parts of Asia, compared to Western countries and Japan, which could lead to differences in treatment outcomes between these regions. The results of this analysis demonstrate the benefits of STRIDE for participants in the Asia-Pacific region, consistent with the full, global study population. Overall, these findings continue to support the use of STRIDE in a diverse population, reflective of uHCC globally.

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularLiver NeoplasmsAdultAgedAsiaFemaleHumansMaleMiddle AgedSorafenibTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, HumanizeddurvalumabSorafenibtremelimumabAsiaEfficacyImmune checkpoint inhibitorSafetyUnresectable hepatocellular carcinoma

Identifiers

PMID39089633

What OpenQuestion holds

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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.