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ACTIVE NOT RECRUITING Phase 3

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

NCT03298451 · View on ClinicalTrials.gov ↗

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

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

1,053 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,324 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03298451 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Texas, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03298451?

This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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