A new imaging agent could tell doctors which liver cancers will resist immunotherapy
NCT ID NCT04965454
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This trial is testing whether a special PET/CT scan using 18F-fluorocholine, along with a liquid biopsy, can predict how well patients with inoperable liver cancer (hepatocellular carcinoma) will respond to immunotherapy. The study enrolls adults with this type of liver cancer who cannot have surgery or whose disease has progressed after other treatments. The goal is to see if these biomarkers can accurately identify patients who will not benefit from immunotherapy after 16 weeks, potentially guiding more personalized treatment decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 18F-fluorocholine, a radioactive imaging agent used with PET/CT scans
- What this could lead to
- If successful, this could help doctors identify early which liver cancer patients are unlikely to benefit from immunotherapy, sparing them from ineffective treatments and side effects.
- What could go wrong
- This is a Phase 2 trial with a modest number of participants, so the biomarker's accuracy may not hold up in larger, more diverse groups. The imaging agent involves radiation exposure, and the test may not perfectly predict response.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2022
- Expected to finish
-
Jun 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 years or older (no upper limit of age) * Hepatocellular carcinoma diagnosis made histologically or radiographically in accordance to National Comprehensive Cancer Network guidelines (3.2019 version or higher) * Does not qualify for surgical resection or locoregional therapy alone or has disease that has progressed after surgical resection and/or locoregional therapy * Has measurable disease defined as at least one tumor lesion that can be accurately measured according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 on CT/MRI completed within past 6 weeks of eligibility screening * Under the care of a licensed medical oncologist * Life expectancy \> 6 months * Deemed eligible for treatment with an immune checkpoint inhibitor agent based on the treating medical oncologist's assessment of previous treatment failure, clinical/performance/virology status, and liver/renal/hematologic function. * Child-Pugh score of 9 or less * Creatinine clearance ≥ 40 mL/min, measured or calculated using the Cockcroft-Gault formula * ALT and AST ≤7x upper limit of normal * Total bilirubin ≤4 mg/dL * Albumin ≥2.8 g/dL Exclusion Criteria: * Weight \> 500 lbs (PET/CT limit) * Pregnant or lactating female (those of child-bearing potential must be re-screened within 7 days prior to PET/CT imaging) * Serious underlying medical condition that would impair patient's ability to tolerate the imaging procedure * Concurrent treatment with a non-targeted therapeutic agent. Concurrent enrollment in an ICI-treatment trial and combination ICI treatment are allowed.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hepatocellular carcinoma non-resectable are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
The Queen's Medical Center
RECRUITINGHonolulu, Hawaii, 96813, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a triple attack shrink untreatable liver tumors?
- Can adding a fourth drug shrink large liver tumors that invade the portal vein?
- Can a Four-Drug cocktail tame inoperable liver cancer?
- Chemo-loaded microspheres aim to starve liver tumors from within
- New combo therapy aims to stop liver cancer in its tracks
- New combo therapy aims to shrink liver tumors in Hard-to-Treat patients