This is a randomized, open-label, multi-center, global, Phase III study to assess the effectiveness and safety of two Immune Therapy drugs, durvalumab given by itself or with tremelimumab versus sorafenib, the standard first line treatment, to treat patients with no prior systemic therapy for advanced liver cancer (hepatocellular carcinoma) that cannot be removed by surgery (unresectable).

Phase 3

Active, not recruiting

• Conditions: Advanced hepatocellular carcinoma (HCC)

• Registration Number: 2024-512212-21-00
• Lead Sponsor: AstraZeneca AB

Brief Summary

To assess the efficacy of durvalumab plus tremelimumab combination therapy compared with sorafenib.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-07-12
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 302

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 - Clinical meaningful ascites - Main portal vein thrombosis - Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months - HBV and HVC coinfection, or HBV and Hep D coinfection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS) is defined as the time from the date of randomization until death due to any cause.		Overall survival (OS) is defined as the time from the date of randomization until death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS), Time to progression (TTP), Objective response rate (ORR), Disease control rate (DCR), and Duration of response (DoR)		Progression-free survival (PFS), Time to progression (TTP), Objective response rate (ORR), Disease control rate (DCR), and Duration of response (DoR)

Trial Locations

Locations (26)

University Hospital Cologne AöR; 🇩🇪 Cologne, Germany

Klinikum der Universitaet Muenchen AöR; 🇩🇪 Munich, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hanover, Germany

Universitaetsklinikum Essen AöR; 🇩🇪 Essen, Germany

Universitaetsklinikum Aachen AöR; 🇩🇪 Aachen, Germany

Universitaetsklinikum Tuebingen AöR; 🇩🇪 Tuebingen, Germany

Clinica Universidad De Navarra; 🇪🇸 Pamplona, Spain

Hospital Universitario Central De Asturias; 🇪🇸 Oviedo, Spain

Hospital Clinic De Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario 12 De Octubre; 🇪🇸 Madrid, Spain

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University Hospital Cologne AöR

🇩🇪Cologne, Germany

Dirk Waldschmidt

Site contact

004922147887735

dirk-thomas.waldschmidt@uk-koeln.de