Hepatocellular Carcinoma Non-resectablePhase 2ExTRACT-HCCNCT04965454
Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma
A Phase 2 study testing Fluorine-18 fluorocholine in people with Hepatocellular Carcinoma Non-resectable, run by Queen's Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable
- What is being tested?
- Fluorine-18 fluorocholine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Queen's Medical Center
Honolulu, Hawaii, 96813
Miles Sato, MS, 808-691-8584, msato@queens.org
Sandi A Kwee, MD, 808-691-5466, skwee@queens.org
About this study
Official title: Clinical Trial of Biomarkers for Predicting Immunotherapy Response 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 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.
Read the detailed description
This is a prospective open-label single-arm diagnostic clinical trial evaluating fluorine-18 fluorocholine (FCH) PET/CT and cell-free DNA mutation profiling (also referred to as genomic liquid biopsy) as diagnostic tools for predicting therapeutic response in advanced HCC patients receiving immune-checkpoint inhibitor (ICI) therapy. All enrolled subjects will undergo diagnostic testing with FCH PET/CT and genomic liquid biopsy before ICI treatment. A fluorine-18 fluorodeoxyglucose (FDG) PET/CT may also be performed before treatment and after 8 weeks if the pre-treatment FCH PET/CT shows low or heterogeneous tumor uptake. The accuracy of tumor biomarkers based on PET/CT and liquid biopsy for predicting therapeutic outcome and disease progression will be determined using objective clinical endpoints based on the radiographic classification of treatment response by RECIST v1.1 applied to CT or MRI performed after 16 weeks of treatment.
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Being tested
- Fluorine-18 fluorocholine
- Keywords
- hepatocellular carcinoma, immunotherapy, positron emission tomography, mutation profiling, liquid biopsy, personalized medicine, diagnostic, fluorocholine, immune checkpoint inhibitor
- Medical subject headings
- Carcinoma, Hepatocellular, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorine-18 fluorocholineCombination product
Also called 18F-fluorocholine, Fluorocholine, 18F-FCH, FCH
18F-fluorocholine is a radiopharmaceutical imaging agent intended for use only with positron emission tomography (PET) imaging. PET with in-line computed tomography imaging of the torso will be performed following intravenous administration of a single unit dose of this investigational new drug.
| Study group | Role | What they receive |
|---|---|---|
| Tested with Biomarkers | Experimental | For this single arm study, all enrolled subjects will undergo diagnostic testing with FCH PET/CT and genomic liquid biopsy before treatment involving an immune checkpoint inhibitor agent. A fluorine-18 fluorodeoxyglucose (FDG) PET/CT may also be performed before treatment and after 8 weeks if the pre-treatment FCH PET/CT shows low or heterogeneous tumor uptake. Receives: Combination Product: Fluorine-18 fluorocholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lack of Objective Response
Lack of Objective Response defined after 16 weeks as meeting criteria for either Stable Disease or Progressive Disease based on RECIST v1.1
Measured: 16 weeks
Secondary outcomes (2)
Objective Response
Objective Response defined after 16 weeks as meeting criteria for either Partial Response or Complete Response based on RECIST v1.1
Measured: 16 weeks
Disease Control
Disease Control defined after 16 weeks as meeting criteria for either Partial Response, Complete Response, or Stable Disease based on RECIST v1.1
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start28 Mar 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective open-label single-arm diagnostic clinical trial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Sandi Kwee, Queen's Medical Center
- Investigators
- Sandi A Kwee, MD, PhD, Principal investigator, The Queen's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965454
- Sponsor's protocol ID
- RA-2021-018
- Other IDs
- R01CA262460
- Acronym
- ExTRACT-HCC
- Status last verified
- Aug 2026
- First submitted
- 7 Jul 2021
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Limited de-identified genomic and phenotypic individual participant data will be made available after the end of the trial via the NIH database of genotypes and phenotypes (dbGaP) in accordance with the NIH Genomic Data Sharing Policy. The individual level data made available by dbGaP is safeguarded by a process of controlled-access with data use limitations to be determined.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Biomarkers for Predicting Immunotherapy Response in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04965454
- Acronym / sponsor ID
- ExTRACT-HCC / RA-2021-018
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Keywords
- hepatocellular carcinoma, immunotherapy, positron emission tomography, mutation profiling, liquid biopsy, personalized medicine, diagnostic, fluorocholine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Queen's Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective open-label single-arm diagnostic clinical trial evaluating fluorine-18 fluorocholine (FCH) PET/CT and cell-free DNA mutation profiling (also referred to as genomic liquid biopsy) as diagnostic tools for predicting therapeutic response in advanced HCC patients receiving immune-checkpoint inhibitor (ICI) therapy. All enrolled subjects will undergo diagnostic testing with FCH PET/CT and genomic liquid biopsy before ICI treatment. A fluorine-18 fluorodeoxyglucose (FDG) PET/CT may also be performed before treatment and after 8 weeks if the pre-treatment FCH PET/CT shows low or heterogeneous tumor uptake. The accuracy of tumor biomarkers based on PET/CT and liquid biopsy for predicting therapeutic outcome and disease progression will be determined using objective clinical endpoints based on the radiographic classification of treatment response by RECIST v1.1 applied to CT or MRI performed after 16 weeks of treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective open-label single-arm diagnostic clinical trial
| Arm | Type | Receives |
|---|---|---|
| Tested with Biomarkers | Experimental | Combination Product: Fluorine-18 fluorocholineFor this single arm study, all enrolled subjects will undergo diagnostic testing with FCH PET/CT and genomic liquid biopsy before treatment involving an immune checkpoint inhibitor agent. A fluorine-18 fluorodeoxyglucose (FDG) PET/CT may also be performed before treatment and after 8 weeks if the pre-treatment FCH PET/CT shows low or heterogeneous tumor uptake. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorine-18 fluorocholineAlso: 18F-fluorocholine, Fluorocholine, 18F-FCH, FCH18F-fluorocholine is a radiopharmaceutical imaging agent intended for use only with positron emission tomography (PET) imaging. PET with in-line computed tomography imaging of the torso will be performed following intravenous administration of a single unit dose of this investigational new drug. | Combination product | Tested with Biomarkers |
Primary outcome
Lack of Objective Response
Time frame: 16 weeks
Lack of Objective Response defined after 16 weeks as meeting criteria for either Stable Disease or Progressive Disease based on RECIST v1.1
2 secondary outcomes
Objective Response
Time frame: 16 weeks
Disease Control
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. Limited de-identified genomic and phenotypic individual participant data will be made available after the end of the trial via the NIH database of genotypes and phenotypes (dbGaP) in accordance with the NIH Genomic Data Sharing Policy. The individual level data made available by dbGaP is safeguarded by a process of controlled-access with data use limitations to be determined.
Related trials for Hepatocellular Carcinoma Non-resectable
Not yet recruitingPhase 2
PEARL Trial: Partial TACE Enhancing Anti-tumor Response With Lenvatinib in Unresectable HCC
Hepatocellular Carcinoma
Active, not recruitingPhase 3
Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer
Recurrent Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v7
Active, not recruitingPhase 1/2
Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer
Stage III Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8
Not yet recruitingObservational study
Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma
Hepatocellular Carcinoma, Hepatocellular Carcinoma (HCC)
Active, not recruiting
BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma Non-resectable
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandi A Kwee, MD, PhD principal investigator
The Queen's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluorine-18 fluorocholine in people with Hepatocellular Carcinoma Non-resectable, run by Queen's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abrar M Al-Adhmi, BS (808-691-7429, aaadhmi@queens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lack of Objective Response (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.