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Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC)

Study acronym: SIERRA
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Completion pushed from Sep 30, 2026 to Dec 30, 2026 Site details revised at 1 of 40 sitesv28 Show 1 more changeShow less
    • Site details revised at 1 of 40 sites
  2. Minor Re-verified, no change to tracked fieldsv27
  3. Minor Primary completion date: Dec 31, 2025 to Mar 30, 2026 Completion date: Mar 31, 2026 to Sep 30, 2026v26 Show 1 more changeShow less
    • Completion date: Mar 31, 2026 to Sep 30, 2026
  4. Minor Primary completion date: Sep 30, 2025 to Dec 31, 2025v25
  5. Minor 2 versions Re-verified since May 19, 2025, no change to tracked fieldsv23-v24
Show 21 earlier versionsHide 21 earlier versions
  1. Minor Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 110 to confirmed 111 · Study sites: 50 to 40v22 Show 2 more changesShow less
    • Enrollment target: estimated 110 to confirmed 111
    • Study sites: 50 to 40
  2. Minor Site details revised at 3 of 50 sitesv21
  3. Minor Re-verified, no change to tracked fieldsv20
  4. Minor Study sites: 49 to 50v19
  5. Minor Primary completion date: Jun 30, 2025 to Sep 30, 2025 Completion date: Dec 30, 2025 to Mar 31, 2026v18 Show 1 more changeShow less
    • Completion date: Dec 30, 2025 to Mar 31, 2026
  6. Minor 4 versions Re-verified since Aug 9, 2024, no change to tracked fieldsv14-v17
  7. Minor Site details revised at 7 of 49 sitesv13
  8. Minor Enrollment target: 140 to 110 Eligibility criteria expanded, about 6 wordsv12 Show 1 more changeShow less
    • Eligibility criteria expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  9. Minor Eligibility criteria expanded, about 69 words Site details revised at 1 of 49 sitesv11 Show 1 more changeShow less
    • Site details revised at 1 of 49 sites

    See this version in full on ClinicalTrials.gov ↗

  10. Minor Site details revised at 1 of 49 sitesv10
  11. Minor Study sites: 50 to 49v9
  12. Minor Study sites: 51 to 50v8
  13. Minor Site details revised at 1 of 51 sitesv7
  14. Minor Study sites: 50 to 51v6
  15. Minor Study sites: 49 to 50 Completion date: Apr 13, 2026 to Dec 30, 2025v5 Show 1 more changeShow less
    • Completion date: Apr 13, 2026 to Dec 30, 2025
  16. Minor Study sites: 48 to 49 Primary completion date: Apr 10, 2026 to Jun 30, 2025v4 Show 1 more changeShow less
    • Primary completion date: Apr 10, 2026 to Jun 30, 2025
  17. Minor Study sites: 47 to 48 Eligibility criteria expanded, about 31 wordsv3 Show 1 more changeShow less
    • Eligibility criteria expanded, about 31 words

    See this version in full on ClinicalTrials.gov ↗

  18. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 14, 2023 to Jun 27, 2023 · Site details revised at 47 of 47 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Jul 14, 2023 to Jun 27, 2023
    • Site details revised at 47 of 47 sites
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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This study will assess the safety and efficacy of Single Tremelimumab Regular Interval Durvalumab (STRIDE) as first-line therapy in participants with advanced unresectable HCC.
Trial Details
NCT Number NCT05883644
Lead Sponsor AstraZeneca
Conditions Advanced Hepatocellular Carcinoma
Enrollment 111 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov