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NCT04965454 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma
A Phase 2 study of Hepatocellular Carcinoma Non-resectable, sponsored by Queen's Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT04965454: Recruiting Phase 2 study of Hepatocellular Carcinoma Non-resectable, sponsored by Queen's Medical Center.
NCT04965454 is a Phase 2 study of Hepatocellular Carcinoma Non-resectable that is actively recruiting participants, run by Queen's Medical Center. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04965454, a Phase 2 study of Hepatocellular Carcinoma Non-resectable, is actively recruiting participants, sponsored by Queen's Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Lack of Objective Response defined after 16 weeks as meeting criteria for either Stable Disease or Progressive Disease based on RECIST v1.1
Conditions Studied
Interventions
- COMBINATION_PRODUCT Fluorine-18 fluorocholine
Study Locations (1)
Hawaii
- The Queen's Medical Center - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-03-28 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 2 |
What NCT04965454 shows while recruiting
NCT04965454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Hepatocellular Carcinoma Non-resectable appearing as the primary indexed condition, and to 1 intervention - of which Fluorine-18 fluorocholine is the first listed.
NCT04965454 reports a single indexed study location in Hawaii.
Frequently Asked Questions
What is clinical trial NCT04965454 about?
NCT04965454 is a clinical study titled "Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma". 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 t...
What is the current status of trial NCT04965454?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2022-03-28. Estimated completion is 2028-06-30.
What conditions does trial NCT04965454 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma Non-resectable.
What interventions are being tested in trial NCT04965454?
The interventions under investigation include: Fluorine-18 fluorocholine (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04965454?
This trial is sponsored by Queen's Medical Center, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04965454 being conducted?
This trial has 1 study location across Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04965454's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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