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

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

This project will test whether measuring PD-L1 (TPS/CPS) and immune exhaustion on circulating tumor cells from blood can help predict which people with head and neck cancer will respond to immunotherapy.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chang Gung Memorial Hospital (other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Taoyuan, City)
• Trial ID: NCT07396259 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with confirmed head and neck cancer who are planning to start immunotherapy and have prior tissue PD-L1 (TPS and/or CPS) results available are the intended participants.

Not a fit: Patients who cannot provide serial blood samples, have uncontrolled medical or psychiatric conditions, lack detectable circulating tumor cells, or are not receiving immunotherapy are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, this approach could provide a noninvasive, repeatable biomarker to help clinicians choose and monitor patients for immunotherapy without needing repeated tissue biopsies.

How similar studies have performed: Prior small studies measuring PD-L1 on CTCs have produced mixed and inconclusive results, so the method is promising but not yet validated in large cohorts.

Eligibility criteria

-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 this trial is running

Taoyuan, City

• 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

Conditions: Circulating Tumor Cells, Immunotherapy, PD-L1 Expression, Liquidbiopsies, Head and neck cancer, immune checkpoint inhibitors, PD-L1 expression, CPS