Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Official record

Identifier

NCT03298451

Recruiting locations

countries

United StatesBrazilCanadaChinaFranceGermanyHong KongIndiaItalyJapanRussiaSouth KoreaSpainTaiwanThailandUkraineVietnam

Interventions studied

DurvalumabTremelimumab (Regimen 1)Tremelimumab (Regimen 2)SorafenibDurvalumab (Regimen 1)Durvalumab (Regimen 2)

Lead sponsor

AstraZeneca

Target enrolment

1324 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Active, not recruiting

First posted

Oct 2, 2017

Last updated on the registry

Jul 27, 2026

Age

18 Years – 100 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion criteria

* 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

Exclusion criteria

* Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
* 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