RecruitingNCT07396259

Predicting Clinical Efficacy of Immunotherapy Using Pre-treatment andContinuousMonitoring of PD-L1 TPS/CPS on CTCs, and Immunity Exhaustion Scores

Dynamically Predicting Clinical Efficacy of Immunotherapy Using Pre-treatment andContinuousMonitoring of PD-L1 TPS/CPS on CTCs, and Immunity Exhaustion Scores - AProspectiveBiomarker Study


Sponsor

Chang Gung Memorial Hospital

Enrollment

150 participants

Start Date

Feb 25, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Head and neck cancer is ranked among the fifth to eighth most prevalent cancers worldwide and is associated with a high mortality rate. Immunotherapy has been established as the first-line standard of care for recurrent and metastatic head and neck cancer. However, patient selection is currently guided by the histological Combined Positive Score (CPS) (KN-048) or Tumor Proportion Score (TPS) (KN-040). A significant limitation is the inability to re-test tumor tissue when disease status changes necessitate therapeutic adjustment, as new tissue is often unavailable. Consequently, liquid biopsy, which allows for repeatable testing and thus constitutes a dynamic biomarker, becomes crucial. Nevertheless, its definitive role in predicting the efficacy of IT has yet to be thoroughly investigated. In this study, our team endeavors to define the CPS score of peripheral circulating tumor cells (CTCs) and evaluate the predictive ability of CTC TPS/CPS for clinical response, using objective clinical outcomes as the ultimate measure.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether measuring a protein marker called PD-L1 on circulating tumor cells (cancer cells found in the blood) can predict how well immunotherapy will work for patients with head and neck cancer. Researchers will also track immune activity over time during treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with head and neck cancer - You are planning to receive immunotherapy treatment - You have a life expectancy of at least 3 months - You have had tissue tested for PD-L1 protein at the treating hospital **You may NOT be eligible if...** - You have severe liver, kidney, or blood disorders - You have a known allergy to the blood draw anticoagulant used in the study - You are pregnant or breastfeeding - Your doctor determines you are not suitable for participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Linkou Chang Gung Memorial Hospital

Taoyuan, City, Taiwan

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NCT07396259


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