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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
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

Full criteria on ClinicalTrials.gov

Sites (143)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BarretosBrazilUnknown status
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CuritibaBrazilUnknown status
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FlorianópolisBrazilUnknown status
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Porto AlegreBrazilUnknown status
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Rio de JaneiroBrazilUnknown status
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São PauloBrazilUnknown status
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CalgaryCanadaUnknown status
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EdmontonCanadaUnknown status
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HamiltonCanadaUnknown status
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KingstonCanadaUnknown status
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LondonCanadaUnknown status
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MontrealCanadaUnknown status
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QuébecCanadaUnknown status
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SherbrookeCanadaUnknown status
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TorontoCanadaUnknown status
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BeijingChinaUnknown status
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ChangchunChinaUnknown status
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ChangshaChinaUnknown status
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ChengduChinaUnknown status
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DalianChinaUnknown status
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FuzhouChinaUnknown status
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GuangzhouChinaUnknown status
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HangzhouChinaUnknown status
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HarbinChinaUnknown status
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HefeiChinaUnknown status
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NanchangChinaUnknown status
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NanjingChinaUnknown status
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NanningChinaUnknown status
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ShanghaiChinaUnknown status
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SuzhouChinaUnknown status
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WuhanChinaUnknown status
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Xi'anChinaUnknown status
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ZhengzhouChinaUnknown status
Universitaetsklinikum Aachen AöR
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AachenGermanyCompleted
University Hospital Cologne AöR
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CologneGermanyCompleted
Universitaetsklinikum Essen (AoR)
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EssenGermanyCompleted
Medizinische Hochschule Hannover
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HanoverGermanyCompleted
Klinikum der Universitaet Muenchen AöR
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MunichGermanyCompleted
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Central De Asturias
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OviedoSpainCompleted
Clínica Universidad de navarra
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PamplonaSpainCompleted
Hopital Beaujon
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ClichyFranceActive, not recruiting
Institut Paoli-Calmettes
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MarseilleFranceActive, not recruiting
C.H.U. de Montpellier - Hopital Saint Eloi
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Montpellier Cedex 5FranceActive, not recruiting
CHU Hôtel Dieu
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Nantes Cedex 1FranceActive, not recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceActive, not recruiting
CHU de Poitiers
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Poitiers CedexFranceActive, not recruiting
Centre Hospitalier Universitaire Rouen
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Rouen CedexFranceActive, not recruiting
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceActive, not recruiting
CHU Toulouse Rangueil
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Toulouse Cedex 9FranceActive, not recruiting
CHRU De Nancy
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Vandoeuvre Les NancyFranceActive, not recruiting
Institut Gustave Roussy
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Villejuif CedexFranceActive, not recruiting
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Hong KongHong Kong SAR ChinaUnknown status
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BangaloreIndiaUnknown status
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BhubneshwarIndiaUnknown status
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ChennaiIndiaUnknown status
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HubliIndiaUnknown status
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HyderabadIndiaUnknown status
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KarmsadIndiaUnknown status
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MumbaiIndiaUnknown status
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NashikIndiaUnknown status
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New DelhiIndiaUnknown status
Azienda Ospedaliera “G. Rummo”
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BeneventoItalyActive, not recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyActive, not recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyActive, not recruiting
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BunkyokuJapanUnknown status
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ChibaJapanUnknown status
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FukuokaJapanUnknown status
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HiroshimaJapanUnknown status
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IizukaJapanUnknown status
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KanazawaJapanUnknown status
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KōtokuJapanUnknown status
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KumamotoJapanUnknown status
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KurumeJapanUnknown status
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MatsuyamaJapanUnknown status
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MitakashiJapanUnknown status
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MusashinoJapanUnknown status
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NagoyaJapanUnknown status
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ŌgakiJapanUnknown status
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OkayamaJapanUnknown status
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OsakaJapanUnknown status
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Ōsaka-sayamaJapanUnknown status
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SagaJapanUnknown status
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SapporoJapanUnknown status
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ShiwaJapanUnknown status
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SuntogunJapanUnknown status
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TsuJapanUnknown status
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YokohamaJapanUnknown status
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BusanSouth KoreaUnknown status
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DaeguSouth KoreaUnknown status
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IlsanSouth KoreaUnknown status
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Seongnam-siSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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MoscowRussiaUnknown status
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MurmanskRussiaUnknown status
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Nizhny NovgorodRussiaUnknown status
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NovosibirskRussiaUnknown status
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ObninskRussiaUnknown status
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OmskRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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UfaRussiaUnknown status
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BangkokThailandUnknown status
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Chang MaiThailandUnknown status
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Khon KaenThailandUnknown status
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PhitsanulokThailandUnknown status
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SongkhlaThailandUnknown status
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Chiayi CityTaiwanUnknown status
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Kaohsiung CityTaiwanUnknown status
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TaichungTaiwanUnknown status
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TainanTaiwanUnknown status
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TaipeiTaiwanUnknown status
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TaoyuanTaiwanUnknown status
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DniproUkraineUnknown status
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IvanoFrankivskUkraineUnknown status
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KharkivUkraineUnknown status
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KropyvnitskyiUkraineUnknown status
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KyivUkraineUnknown status
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LvivUkraineUnknown status
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OdesaUkraineUnknown status
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UzhhorodUkraineUnknown status
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Ann ArborUnited StatesUnknown status
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BaltimoreUnited StatesUnknown status
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CharlotteUnited StatesUnknown status
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DallasUnited StatesUnknown status
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Fort MyersUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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JacksonvilleUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
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MurrayUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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OrangeUnited StatesUnknown status
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PittsburghUnited StatesUnknown status
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PortlandUnited StatesUnknown status
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RochesterUnited StatesUnknown status
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San FranciscoUnited StatesUnknown status
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Washington D.C.United StatesUnknown status
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WestwoodUnited StatesUnknown status
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HanoiVietnamUnknown status
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HochiminhVietnamUnknown status

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