Evaluating biomarkers for predicting treatment response in liver cancer
Clinical Trial of Biomarkers for Predicting Immunotherapy Response in Hepatocellular Carcinoma
PHASE2 · Queen's Medical Center · NCT04965454
This study is testing if special imaging and blood tests can help predict how well people with inoperable liver cancer will respond to a new type of treatment.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Queen's Medical Center (other) |
| Locations | 1 site (Honolulu, Hawaii) |
| Trial ID | NCT04965454 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of PET/CT imaging and genomic liquid biopsy as predictors of response to immune-checkpoint inhibitor therapy in patients with inoperable hepatocellular carcinoma (HCC). Participants will undergo diagnostic testing with fluorine-18 fluorocholine (FCH) PET/CT and cell-free DNA mutation profiling before starting treatment. The study will evaluate the accuracy of these biomarkers in predicting therapeutic outcomes and disease progression after 16 weeks of treatment. The results will be based on objective clinical endpoints using established radiographic classification methods.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with inoperable hepatocellular carcinoma who have measurable disease and are eligible for immune checkpoint inhibitor therapy.
Not a fit: Patients who have resectable tumors or those with a Child-Pugh score greater than 9 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for predicting treatment responses in patients with advanced liver cancer, potentially leading to more personalized and effective treatment strategies.
How similar studies have performed: Other studies have shown promise in using imaging and genomic profiling to predict treatment responses in various cancers, suggesting that this approach may be viable for hepatocellular carcinoma as well.
Eligibility criteria
Show full inclusion / exclusion 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) * 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.
Where this trial is running
Honolulu, Hawaii
- The Queen's Medical Center — Honolulu, Hawaii, United States (RECRUITING)
Study contacts
- Principal investigator: Sandi A Kwee, MD, PhD — The Queen's Medical Center
- Study coordinator: Abrar M Al-Adhmi, BS
- Email: aaadhmi@queens.org
- Phone: 808-691-7429
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepatocellular Carcinoma Non-resectable, hepatocellular carcinoma, immunotherapy, positron emission tomography, mutation profiling, liquid biopsy, personalized medicine, diagnostic