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

NCT03298451 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1324

Last updated 2026-03-20

Study results available
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Summary

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

Conditions

Interventions

DRUG

Durvalumab

Durvalumab IV (intravenous infusion).

DRUG

Tremelimumab (Regimen 1)

Tremelimumab IV (intravenous infusion).

DRUG

Tremelimumab (Regimen 2)

Tremelimumab IV (intravenous infusion).

DRUG

Sorafenib

Sorafenib, as per standard of care

DRUG

Durvalumab (Regimen 1)

Durvalumab IV (intravenous infusion).

DRUG

Durvalumab (Regimen 2)

Durvalumab IV (intravenous infusion).

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-11
Primary Completion
2021-08-27
Completion
2026-08-27
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • China
  • France
  • Germany
  • Hong Kong
  • India
  • Italy
  • Japan
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Ukraine
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03298451 on ClinicalTrials.gov