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

Running, not enrolling · Phase 3

Conditions studied: Hepatocellular Carcinoma

In brief

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

Key facts

Study ID

NCT03298451

Run by

AstraZeneca

People needed

1324

Starts

2017-10-11

Expected to finish

2027-12-31

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Orange, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Fort Myers, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Westwood, Kansas, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — New York, New York, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Portland, Oregon, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Dallas, Texas, United States
• Research Site — Dallas, Texas, United States
• Research Site — Dallas, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Murray, Utah, United States
• Research Site — Barretos, Brazil
• Research Site — Curitiba, Brazil
• Research Site — Florianópolis, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Rio de Janeiro, Brazil
• Research Site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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