Blood-based PD-L1 and immune exhaustion testing on circulating tumor cells to guide immunotherapy in head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will take blood before treatment and at scheduled follow-ups to isolate circulating tumor cells (CTCs) and peripheral immune cells, stain them for PD-L1 and immune-exhaustion markers, and calculate CTC TPS and CPS scores. Investigators will compare CTC-based TPS/CPS with existing tissue TPS/CPS and correlate those liquid-biopsy measures with clinical responses to immune checkpoint inhibitors. The protocol will explore which peripheral immune cell types to include in the CPS calculation and assess assay reproducibility over time. Findings will show whether repeatable blood testing can serve as a dynamic biomarker for selecting and monitoring patients on immunotherapy.

Why it matters

Who can join: the full rules

-Inclusion Criteria: Cancer Subjects- Age: 18 years of age or older. Diagnosis: Confirmed diagnosis of Head and Neck Cancer with plans to undergo immunotherapy.

Life Expectancy: Evaluated by a physician to have a life expectancy of at least 3 months.

Pathology/Biomarkers: Must have an available tissue biopsy or existing tissue staining results for PD-L1 TPS and/or PD-L1 CPS at this hospital.

Healthy Subjects- Health Status: No prior diagnosis of any cancer. Age: 18 years of age or older.

-Exclusion Criteria: Mental Health: Presence of psychiatric disorders. Comorbidities: Presence of uncontrolled complications. Logistics: Difficulty with blood collection or unwillingness to comply with follow-up blood draw schedules.

Clinical Judgment: Individuals assessed by the physician as unsuitable for enrollment in the study.

Where it's running

• Linkou Chang Gung Memorial Hospital
  Taoyuan, City, Taiwan Recruiting

Study contacts

• Principal investigator: Hung-Ming Wang — Division of Oncology, Chang Gung Memorial Hospital
• Study coordinator: Hung-Ming Wang
• Email: whm526@cgmh.org.tw
• Phone: +886975368112

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.