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Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma (ExTRACT-HCC)

Primary Purpose

Hepatocellular Carcinoma Non-resectable

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Fluorine-18 fluorocholine

About this trial

This is an interventional other trial for Hepatocellular Carcinoma Non-resectable focused on measuring hepatocellular carcinoma, immunotherapy, positron emission tomography, mutation profiling, liquid biopsy, personalized medicine, diagnostic, fluorocholine, immune checkpoint inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)
Barcelona Clinic Liver Cancer Stage B or C
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 7 or less
Creatinine clearance ≥ 40 mL/min, measured or calculated using the Cockcroft-Gault formula
ALT and AST ≤5x upper limit of normal
Total bilirubin ≤3 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.

Sites / Locations

The Queen's Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tested with Biomarkers

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Objective Response

Objective Response defined after 16 weeks as meeting criteria for either Partial Response or Complete Response based on RECIST v1.1

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

Full Information

NCT ID

NCT04965454

First Posted

July 7, 2021

Last Updated

May 9, 2023

Sponsor

Queen's Medical Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04965454

Brief Title

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

Acronym

ExTRACT-HCC

Official Title

Clinical Trial of Biomarkers for Predicting Immunotherapy Response in Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 28, 2022 (Actual)

Primary Completion Date

June 30, 2026 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen's Medical Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma Non-resectable

Keywords

hepatocellular carcinoma, immunotherapy, positron emission tomography, mutation profiling, liquid biopsy, personalized medicine, diagnostic, fluorocholine, immune checkpoint inhibitor

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

prospective open-label single-arm diagnostic clinical trial

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tested with Biomarkers

Arm Type

Experimental

Arm Description

Intervention Type

Combination Product

Intervention Name(s)

Fluorine-18 fluorocholine

Other Intervention Name(s)

18F-fluorocholine, Fluorocholine, 18F-FCH, FCH, [18F]fluorocholine

Intervention Description

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.

Primary Outcome Measure Information:

Title

Lack of Objective Response

Description

Lack of Objective Response defined after 16 weeks as meeting criteria for either Stable Disease or Progressive Disease based on RECIST v1.1

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Objective Response

Description

Objective Response defined after 16 weeks as meeting criteria for either Partial Response or Complete Response based on RECIST v1.1

Time Frame

16 weeks

Title

Disease Control

Description

Disease Control defined after 16 weeks as meeting criteria for either Partial Response, Complete Response, or Stable Disease based on RECIST v1.1

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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) Barcelona Clinic Liver Cancer Stage B or C 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 7 or less Creatinine clearance ≥ 40 mL/min, measured or calculated using the Cockcroft-Gault formula ALT and AST ≤5x upper limit of normal Total bilirubin ≤3 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Miles M Sato, MS, MPH

Phone

808-691-8584

msato@queens.org

First Name & Middle Initial & Last Name or Official Title & Degree

Tim Kelleher, RN

Phone

808-691-8582

tkelleher@queens.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sandi A Kwee, MD, PhD

Organizational Affiliation

The Queen's Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Queen's Medical Center

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96813

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Miles Sato, MS

Phone

808-691-8584

msato@queens.org

First Name & Middle Initial & Last Name & Degree

Sandi A Kwee, MD

Phone

808-691-5466

skwee@queens.org

First Name & Middle Initial & Last Name & Degree

Sandi A Kwee, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing Time Frame

Starting 6 months after last publication at conclusion of the trial.

IPD Sharing Access Criteria

Controlled-Access. Contact NIH dbGaP for more information.

IPD Sharing URL

https://www.ncbi.nlm.nih.gov/gap/

Learn more about this trial

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

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