For Healthcare Professionals

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

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About the study

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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. HCC based on histopathological confirmation
  2. No prior systemic therapy for HCC
  3. Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C
  4. Child-Pugh Score class A
  5. ECOG performance status of 0 or 1 at enrollment

EXCLUSION CRITERIA

  1. Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
  2. Clinically meaningful ascites
  3. Main portal vein tumor thrombosis
  4. Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
  5. HBV and HVC co-infection, or HBV and Hep D co-infection
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-877-240-9479Email iconEmail Study Center

Study’s details


Contition

Hepatocellular Carcinoma

Age (in years)

18 - 100

Phase

Phase 3

Participants needed

1324

Est. Completion Date

Aug 2024

Treatment type

Interventional


Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT03298451

Study number

D419CC00002

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