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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 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.

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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

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

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03298451

The ClinicalTrials.gov registry entry for NCT03298451 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,324 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 248-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (434% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.