Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03298451 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Hepatocellular Carcinoma, sponsored by AstraZeneca.

Active
Registry status
Phase 3
Development phase
1,324
Enrollment target
20
Study locations

NCT03298451: Active Phase 3 study of Hepatocellular Carcinoma, sponsored by AstraZeneca.

NCT03298451 is a Phase 3 study of Hepatocellular Carcinoma that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 1,324 participants, above the 248-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (434% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03298451, a Phase 3 study of Hepatocellular Carcinoma, is active but no longer recruiting, sponsored by AstraZeneca.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,324 participants
Enrollment target
20
Study locations

Study 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

Primary Outcome

OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This primary outcome measure pre

Conditions Studied

Hepatocellular Carcinoma

Interventions

  • DRUG Durvalumab
  • DRUG Sorafenib
  • DRUG Tremelimumab (Regimen 1)
  • DRUG Tremelimumab (Regimen 2)
  • DRUG Durvalumab (Regimen 1)

Study Locations (20)

Texas

  • Research Site - Dallas
  • Research Site - Dallas
  • Research Site - Dallas
  • Research Site - Houston
  • Research Site - Houston

California

  • Research Site - Los Angeles
  • Research Site - Orange
  • Research Site - San Francisco

Florida

  • Research Site - Fort Myers
  • Research Site - Jacksonville

District of Columbia

  • Research Site - Washington D.C.

Kansas

  • Research Site - Westwood

Maryland

  • Research Site - Baltimore

Michigan

  • Research Site - Ann Arbor

Minnesota

  • Research Site - Rochester

Trial Details

FieldValue
Enrollment Target 1,324 participants
Start Date 2017-10-11
Est. Completion 2026-08-27
Phase Phase 3
AstraZeneca

1,285 total trials

What the registry record for NCT03298451 still lists

NCT03298451 is an interventional study that assigns participants to a tested intervention. Its 1,324 participants enrollment target places it among the larger protocols in the corpus, above the 248-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (434% higher).

The record links to 1 condition, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Durvalumab is the first listed.

NCT03298451 names 20 study sites across 13 states, led by Texas, California, Florida.

Frequently Asked Questions

What is clinical trial NCT03298451 about?

NCT03298451 is a clinical study titled "Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma". 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 can...

What is the current status of trial NCT03298451?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,324 participants. The study started on 2017-10-11. Estimated completion is 2026-08-27.

What conditions does trial NCT03298451 study?

This clinical trial studies the following conditions: Hepatocellular Carcinoma.

What interventions are being tested in trial NCT03298451?

The interventions under investigation include: Durvalumab (DRUG), Sorafenib (DRUG), Tremelimumab (Regimen 1) (DRUG), Tremelimumab (Regimen 2) (DRUG), Durvalumab (Regimen 1) (DRUG).

Who is sponsoring clinical trial NCT03298451?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03298451 being conducted?

This trial has 20 study locations across California, District of Columbia, Florida, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Hepatocellular Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03298451's enrollment target sits among peer trials

1,324 6th of 145 higher than 140 of 145 other Hepatocellular Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hepatocellular Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT05097287 · 1,324 participants · Phase 4

    Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma

  • NCT05889182 · 1,328 participants · Phase 3

    A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy

  • NCT06557005 · 1,320 participants · NA

    Facilitated Transitions From Postpartum to Primary Care Coordination for People With Chronic Conditions

  • NCT07213908 · 1,320 participants · NA

    Comparing Two School-Based Sleep Health Interventions To Promote Sleep Quality in Youth

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT03298451, the US trial registry maintained by the National Library of Medicine. NCT03298451 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.