CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 1,324 enrolled
Drug / intervention
Durvalumab +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03298451
NCT03298451Phase 3Active

A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

AstraZeneca·interventional·Posted Oct 2, 2017·Updated Mar 20, 2026

In Brief

A Phase 3 clinical trial evaluating Durvalumab, Tremelimumab (Regimen 1), and 4 other interventions for Hepatocellular Carcinoma. Active but no longer recruiting, targeting 1,324 participants across 160 sites in 17 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, Canada, China, France, Germany, Hong Kong, India, Italy, Japan, Russia, South Korea, Spain, Taiwan, Thailand, Ukraine, United States, Vietnam
Collaborators--

Timeline

Phase 3Active
201820192020202120222023202420252026
First PostedOct 2, 2017
Enrollment StartOct 11, 2017
Primary CompletionAug 27, 2021
Study CompletionAug 27, 2026
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.8 years ago

Interventions

Durvalumabdrug

Durvalumab IV (intravenous infusion).

Tremelimumab (Regimen 1)drug

Tremelimumab IV (intravenous infusion).

Tremelimumab (Regimen 2)drug

Tremelimumab IV (intravenous infusion).

Sorafenibdrug

Sorafenib, as per standard of care

Durvalumab (Regimen 1)drug

Durvalumab IV (intravenous infusion).

Durvalumab (Regimen 2)drug

Durvalumab IV (intravenous infusion).