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

NCT07396259 | Recruiting

• 1 other identifier: 202401021
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immunotherapy; PD-L1 Expression; Liquidbiopsies; Circulating Tumor Cells (CTCs)

Keywords

Head and neck cancer; immune checkpoint inhibitors; PD-L1 expression; Liquidbiopsies; CPS; TPS; circulating tumor cells

Outcome Measures

Primary Outcomes (1)

• ICI responses, concordance to tissue PD-L1 expression

  Use a Published Novel circulaitng tumor cells (CTCs) Identification technologytoexaminePD-L1 expression on CTCs by tumor positive score (TPS, %) and combinedpositivescore(CPS)

  3 years

Secondary Outcomes (1)

• Progression-Free Survival

  3 years

Other Outcomes (1)

• Overall survival

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Head and neck cancer patients scheduled for immunotherapyㄡ

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan District, City, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplastic Cells, Circulating; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site

Study Officials

• Hung-Ming Wang

  Division of Oncology, Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Ming Wang

CONTACT

+886975368112; whm526@cgmh.org.tw

Chia-Hsun Hsieh

CONTACT

+886975366137; wisdom5000@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 9, 2026
• Study Start: February 25, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 9, 2026

Record last verified: 2025-12

Locations

TW (1)