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Regorafenib and Durvalumab for the Treatment of High-Risk Liver Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Results first posted: Jul 20, 2026v17
  2. Secondary endpoints revised (6)
    • Primary endpoint revised
    v16
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 30 to confirmed 4
    • Study sites: 5 to 3
    v15
  4. Primary completion date: Dec 5, 2024 to Dec 5, 2025
    • Site details revised at 1 of 5 sites
    v14
  5. Site contacts updated at 1 of 5 sitesv13
Show 11 earlier versionsHide 11 earlier versions
  1. Start date: Jun 29, 2023 to Jul 1, 2023v12
  2. Site details revised at 1 of 5 sitesv11
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 30, 2023 to Jun 29, 2023
    • Site details revised at 5 of 5 sites
    v10
  4. Enrollment target: 27 to 30v9 Show 5 more changesShow less
    • Start date: Jun 1, 2023 to Jun 30, 2023
    • Eligibility criteria revised
    • Study sites revised (5)
    • Study description shortened, about 1 word
    • Study title shortened, about 1 word
  5. Primary completion date: Dec 5, 2023 to Dec 5, 2024
    • Site contacts updated at 1 of 5 sites
    v8
  6. Start date: Mar 1, 2023 to Jun 1, 2023v7
  7. Start date: Jul 30, 2022 to Mar 1, 2023
    • Study sites: 4 to 5
    v6
  8. Start date: Apr 30, 2022 to Jul 30, 2022v5
  9. Study title shortened, about 10 wordsv4
  10. Study title expanded, about 11 wordsv3
  11. Site contacts updated at 2 of 4 sitesv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This phase II trial tests whether regorafenib and durvalumab work to shrink tumors in patients with high-risk liver cancer. Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving regorafenib and durvalumab may work better in treating patients with high-risk liver cancer.
Trial Details
NCT Number NCT05194293
Lead Sponsor Academic and Community Cancer Research United
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Stage IB Hepatocellular Carcinoma AJCC v8, Stage II Hepatocellular Carcinoma AJCC v8, Stage III Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8
Related terms Carcinoma, Hepatocellular
Enrollment 4 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov