Hepatocellular Carcinoma Non-resectable Clinical Trial
— ExTRACT-HCCOfficial 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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 31, 2027 |
Est. primary completion date | June 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | The Queen's Medical Center | Honolulu | Hawaii |
Lead Sponsor | Collaborator |
---|---|
Queen's Medical Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 16 weeks | |
Secondary | Objective Response | Objective Response defined after 16 weeks as meeting criteria for either Partial Response or Complete Response based on RECIST v1.1 | 16 weeks | |
Secondary | 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 | 16 weeks |
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