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Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma

Study acronym: ExTRACT-HCC
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv11
  2. Primary completion date: Jun 30, 2027 to Dec 31, 2027
    • Study completion date: Dec 31, 2027 to Jun 30, 2028
    v10
  3. Primary completion date: Jun 30, 2026 to Jun 30, 2027
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    • Eligibility criteria expanded, about 14 words
    v9
  4. Re-verified, no change to tracked fieldsv8
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 1, 2022 to Mar 28, 2022
    • Site details revised
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Start date: Jan 1, 2022 to Mar 1, 2022v6
  2. Start date: Oct 1, 2021 to Jan 1, 2022
    • Eligibility criteria expanded, about 33 words
    v5
  3. 2 versions Re-verified since Jul 27, 2021, no change to tracked fieldsv3-v4
  4. Eligibility criteria shortened, about 12 wordsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 prospective clinical trial will evaluate PET/CT and genomic liquid biopsy based biomarkers as predictors of clinical therapeutic response to immune-checkpoint inhibitor (ICI) therapy for patients with inoperable hepatocellular carcinoma (HCC). The primary objective of this diagnostic trial is to assess the accuracy of pre-treatment fluorine-18 (18F-) fluorocholine (FCH) PET/CT for predicting a lack of objective response (LOR) after 16 weeks of ICI therapy.
Trial Details
NCT Number NCT04965454
Lead Sponsor Queen's Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Hepatocellular Carcinoma Non-resectable
Related terms Carcinoma, Hepatocellular, Disease
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov