Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
NCT ID: NCT03298451
Last Updated: 2026-01-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
1324 participants
INTERVENTIONAL
2017-10-11
2026-08-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With Unresectable Hepatocellular Carinoma
NCT05557838
A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma
NCT02519348
Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma
NCT07081633
Durvalumab and Tremelimumab With or Without Hepatic Arterial Infusion of Chemotherapy in Hepatocellular Carcinoma
NCT06904170
Durvalumab and Tremelimumab After Radioembolization for the Treatment of Unresectable, Locally Advanced Liver Cancer
NCT04605731
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients in all treatment arms may continue receiving their originally assigned treatment, at the Investigator's discretion, until progression
Patients in all arms with confirmed PD who, in the Investigator's opinion, continue to receive benefit from their assigned treatment and meet the criteria for treatment in the setting of PD may continue to receive their assigned treatment.
If a patient discontinues study drug(s) due to disease progression, the patient will enter survival follow-up. Patients who have discontinued treatment due to toxicity or symptomatic deterioration or who have commenced subsequent anticancer therapy, will have tumor assessments until confirmed PD and will be followed for survival
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
Durvalumab
Durvalumab
Durvalumab IV (intravenous infusion).
Arm 2
Durvalumab in combination with tremelimumab (Regimen 1)
Tremelimumab (Regimen 1)
Tremelimumab IV (intravenous infusion).
Durvalumab (Regimen 1)
Durvalumab IV (intravenous infusion).
Arm 3
Durvalumab in combination with tremelimumab (Regimen 2)
Tremelimumab (Regimen 2)
Tremelimumab IV (intravenous infusion).
Durvalumab (Regimen 2)
Durvalumab IV (intravenous infusion).
Arm 4
Sorafenib
Sorafenib
Sorafenib, as per standard of care
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Durvalumab
Durvalumab IV (intravenous infusion).
Tremelimumab (Regimen 1)
Tremelimumab IV (intravenous infusion).
Tremelimumab (Regimen 2)
Tremelimumab IV (intravenous infusion).
Sorafenib
Sorafenib, as per standard of care
Durvalumab (Regimen 1)
Durvalumab IV (intravenous infusion).
Durvalumab (Regimen 2)
Durvalumab IV (intravenous infusion).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* No prior systemic therapy for HCC
* Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C
* Child-Pugh Score class A
* ECOG performance status of 0 or 1 at enrollment
Exclusion Criteria
* Clinically meaningful ascites
* Main portal vein tumor thrombosis
* Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
* HBV and HVC co-infection, or HBV and Hep D co-infection
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Los Angeles, California, United States
Research Site
Orange, California, United States
Research Site
San Francisco, California, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Fort Myers, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Westwood, Kansas, United States
Research Site
Baltimore, Maryland, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Rochester, Minnesota, United States
Research Site
New York, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Portland, Oregon, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Dallas, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Murray, Utah, United States
Research Site
Barretos, , Brazil
Research Site
Curitiba, , Brazil
Research Site
Florianópolis, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
Rio de Janeiro, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Kingston, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
Research Site
Beijing, , China
Research Site
Changchun, , China
Research Site
Changsha, , China
Research Site
Chengdu, , China
Research Site
Dalian, , China
Research Site
Fuzhou, , China
Research Site
Guangzhou, , China
Research Site
Hangzhou, , China
Research Site
Harbin, , China
Research Site
Hefei, , China
Research Site
Nanchang, , China
Research Site
Nanjing, , China
Research Site
Nanning, , China
Research Site
Shanghai, , China
Research Site
Suzhou, , China
Research Site
Wuhan, , China
Research Site
Xi'an, , China
Research Site
Zhengzhou, , China
Research Site
Clichy, , France
Research Site
Lille, , France
Research Site
Marseille, , France
Research Site
Montpellier, , France
Research Site
Nancy, , France
Research Site
Nantes, , France
Research Site
Nice, , France
Research Site
Pessac, , France
Research Site
Poitiers, , France
Research Site
Reims, , France
Research Site
Rouen, , France
Research Site
Saint-Etienne, , France
Research Site
Toulouse, , France
Research Site
Villejuif, , France
Research Site
Aachen, , Germany
Research Site
Cologne, , Germany
Research Site
Essen, , Germany
Research Site
Hanover, , Germany
Research Site
Heidelberg, , Germany
Research Site
Leipzig, , Germany
Research Site
Mainz, , Germany
Research Site
München, , Germany
Research Site
Tübingen, , Germany
Research Site
Ulm, , Germany
Research Site
Hong Kong, , Hong Kong
Research Site
Bangalore, , India
Research Site
Bhubneshwar, , India
Research Site
Chennai, , India
Research Site
Hubli, , India
Research Site
Hyderabad, , India
Research Site
Karmsad, , India
Research Site
Mumbai, , India
Research Site
Nashik, , India
Research Site
New Delhi, , India
Research Site
Benevento, , Italy
Research Site
Meldola, , Italy
Research Site
Milan, , Italy
Research Site
Napoli, , Italy
Research Site
Perugia, , Italy
Research Site
Pisa, , Italy
Research Site
Roma, , Italy
Research Site
Rozzano, , Italy
Research Site
Bunkyoku, , Japan
Research Site
Chiba, , Japan
Research Site
Fukuoka, , Japan
Research Site
Hiroshima, , Japan
Research Site
Iizuka, , Japan
Research Site
Kanazawa, , Japan
Research Site
Kōtoku, , Japan
Research Site
Kumamoto, , Japan
Research Site
Kurume, , Japan
Research Site
Matsuyama, , Japan
Research Site
Mitakashi, , Japan
Research Site
Musashino, , Japan
Research Site
Nagoya, , Japan
Research Site
Okayama, , Japan
Research Site
Osaka, , Japan
Research Site
Ōgaki, , Japan
Research Site
Ōsaka-sayama, , Japan
Research Site
Saga, , Japan
Research Site
Sapporo, , Japan
Research Site
Shiwa, , Japan
Research Site
Suntogun, , Japan
Research Site
Tsu, , Japan
Research Site
Yokohama, , Japan
Research Site
Moscow, , Russia
Research Site
Murmansk, , Russia
Research Site
Nizhny Novgorod, , Russia
Research Site
Novosibirsk, , Russia
Research Site
Obninsk, , Russia
Research Site
Omsk, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Ufa, , Russia
Research Site
Ilsan, Gyeonggi-do, South Korea
Research Site
Seongnam-si, Gyeonggi-do, South Korea
Research Site
Busan, , South Korea
Research Site
Daegu, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Oviedo, , Spain
Research Site
Pamplona Madrid, , Spain
Research Site
Santander, , Spain
Research Site
Chiayi City, , Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Tainan, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Bangkok, , Thailand
Research Site
Chang Mai, , Thailand
Research Site
Khon Kaen, , Thailand
Research Site
Phitsanulok, , Thailand
Research Site
Songkhla, , Thailand
Research Site
Dnipro, , Ukraine
Research Site
IvanoFrankivsk, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Kropyvnitskyi, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Lviv, , Ukraine
Research Site
Odesa, , Ukraine
Research Site
Uzhhorod, , Ukraine
Research Site
Hanoi, , Vietnam
Research Site
Hochiminh, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rimassa L, Chan SL, Sangro B, Lau G, Kudo M, Reig M, Breder V, Ryu MH, Ostapenko Y, Sukeepaisarnjaroen W, Varela M, Tougeron D, Crysler OV, Bouattour M, Van Dao T, Tam VC, Faccio A, Furuse J, Jeng LB, Kang YK, Kelley RK, Paskow MJ, Ran D, Xynos I, Kurland JF, Negro A, Abou-Alfa GK. Five-year overall survival update from the HIMALAYA study of tremelimumab plus durvalumab in unresectable HCC. J Hepatol. 2025 Oct;83(4):899-908. doi: 10.1016/j.jhep.2025.03.033. Epub 2025 Apr 11.
Lau G, Abou-Alfa GK, Cheng AL, Sukeepaisarnjaroen W, Van Dao T, Kang YK, Thungappa SC, Kudo M, Sangro B, Kelley RK, Furuse J, Park JW, Sunpaweravong P, Fasolo A, Yau T, Kawaoka T, Azevedo S, Reig M, Assenat E, Yarchoan M, He AR, Makowsky M, Gupta C, Negro A, Chan SL. Outcomes in the Asian subgroup of the phase III randomised HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma. J Hepatol. 2025 Feb;82(2):258-267. doi: 10.1016/j.jhep.2024.07.017. Epub 2024 Jul 31.
Sangro B, Galle PR, Kelley RK, Charoentum C, De Toni EN, Ostapenko Y, Heo J, Cheng AL, Wilson Woods A, Gupta C, Abraham J, McCoy CL, Patel N, Negro A, Vogel A, Abou-Alfa GK. Patient-Reported Outcomes From the Phase III HIMALAYA Study of Tremelimumab Plus Durvalumab in Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2024 Aug 10;42(23):2790-2799. doi: 10.1200/JCO.23.01462. Epub 2024 May 28.
Abou-Alfa GK, Lau G, Kudo M, Chan SL, Kelley RK, Furuse J, Sukeepaisarnjaroen W, Kang YK, Van Dao T, De Toni EN, Rimassa L, Breder V, Vasilyev A, Heurgue A, Tam VC, Mody K, Thungappa SC, Ostapenko Y, Yau T, Azevedo S, Varela M, Cheng AL, Qin S, Galle PR, Ali S, Marcovitz M, Makowsky M, He P, Kurland JF, Negro A, Sangro B. Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma. NEJM Evid. 2022 Aug;1(8):EVIDoa2100070. doi: 10.1056/EVIDoa2100070. Epub 2022 Jun 6.
Addendum 1: Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of hepatocellular carcinoma. J Immunother Cancer. 2023 Sep;11(9):e002794add1. doi: 10.1136/jitc-2021-002794add1. No abstract available.
Patel TH, Brewer JR, Fan J, Cheng J, Shen YL, Xiang Y, Zhao H, Lemery SJ, Pazdur R, Kluetz PG, Fashoyin-Aje LA. FDA Approval Summary: Tremelimumab in Combination with Durvalumab for the Treatment of Patients with Unresectable Hepatocellular Carcinoma. Clin Cancer Res. 2024 Jan 17;30(2):269-273. doi: 10.1158/1078-0432.CCR-23-2124.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-512212-21-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2016-005126-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D419CC00002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.