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 liver cancer (hepatocellular carcinoma) that cannot be removed by surgery (unresectable).

Phase 1

• Conditions: unresectable hepatocellular carcinoma (HCC); MedDRA version: 20.0Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-005126-11-IT
• Lead Sponsor: ASTRAZENECA AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-15
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

- HCC (unresectable hepatocellular carcinoma) histopathological diagnosis confirmation based on tumor tissue
- 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
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 960
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 640

Exclusion Criteria

-Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
-Ascites that requires ongoing paracentesis to control symptoms (within 6 weeks prior to the first scheduled dose)
-Main portal vein thrombosis
-Active or prior documented GI variceal bleed or history of upper GI bleeding, ulcers or esophageal varices with bleeding within 12 months
-HBV and HCV co-infection

Study & Design

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