NCT03298451Active, not recruitingPhase 3
Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1324 (actual)
- First submitted
- 19 Sept 2017
- Start date
- 11 Oct 2017
- Primary completion date
- 27 Aug 2021
- Lead sponsor
- AstraZeneca
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT03298451
- EU CT number
- 2024-512212-21-00
- EudraCT number
- 2016-005126-11
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 1324
- From 11 Oct 2017 to the primary completion date, 27 Aug 2021
- 143 sites in 17 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
- Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
Other illness
- Main portal vein tumor thrombosis
- HBV and HVC co-infection, or HBV and Hep D co-infection
Other
- Clinically meaningful ascites
Who the study is looking for
- HCC based on histopathological confirmation
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (143)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Florianópolis | Brazil | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Research Site Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Dalian | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Universitaetsklinikum Aachen AöR Coordinator of this site? Confirm its status | Aachen | Germany | Completed |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Completed |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Completed |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Completed |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Completed |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Completed |
| Hopital Beaujon Coordinator of this site? Confirm its status | Clichy | France | Active, not recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| C.H.U. de Montpellier - Hopital Saint Eloi Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| CHU Hôtel Dieu Coordinator of this site? Confirm its status | Nantes Cedex 1 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Active, not recruiting |
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Active, not recruiting |
| CHU Toulouse Rangueil Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy | France | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif Cedex | France | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Bhubneshwar | India | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Hubli | India | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Karmsad | India | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Nashik | India | Unknown status |
| Research Site Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Azienda Ospedaliera “G. Rummo” Coordinator of this site? Confirm its status | Benevento | Italy | Active, not recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Bunkyoku | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Iizuka | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Kōtoku | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Kurume | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Mitakashi | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Musashino | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Ōgaki | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Ōsaka-sayama | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Saga | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Shiwa | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Suntogun | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Tsu | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Ilsan | South Korea | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Murmansk | Russia | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Obninsk | Russia | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Omsk | Russia | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Ufa | Russia | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Chang Mai | Thailand | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Khon Kaen | Thailand | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Phitsanulok | Thailand | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Songkhla | Thailand | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Chiayi City | Taiwan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Dnipro | Ukraine | Unknown status |
| Research Site Coordinator of this site? Confirm its status | IvanoFrankivsk | Ukraine | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Kropyvnitskyi | Ukraine | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Lviv | Ukraine | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Odesa | Ukraine | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Uzhhorod | Ukraine | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Murray | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Westwood | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Hanoi | Vietnam | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Hochiminh | Vietnam | Unknown status |
Related publications
- Plain language summary of five-year overall survival update from the HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma (liver cancer).Future Oncol · 2026 · PMID 42108643
- 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.Liver Cancer · 2025 · PMID 41585428
This page is information, not medical advice. Discuss any trial with your doctor.