Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT07396259

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

Led by Chang Gung Memorial Hospital · Updated on 2026-02-09

150

Participants Needed

1

Research Sites

305 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Cancer patients aged 18 years or older with confirmed head and neck cancer planning immunotherapy
  • Life expectancy of at least 3 months as assessed by a physician
  • Available tissue biopsy or PD-L1 TPS/CPS staining results from this hospital
  • Healthy subjects aged 18 years or older with no prior cancer diagnosis
Not Eligible

You will not qualify if you...

  • Presence of psychiatric disorders
  • Uncontrolled medical complications
  • Difficulty with blood collection or unwillingness to comply with follow-up blood draws
  • Physician assessment deeming the individual unsuitable for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Linkou Chang Gung Memorial Hospital

Taoyuan, City, Taiwan, 333

Actively Recruiting

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Research Team

H

Hung-Ming Wang

CONTACT

C

Chia-Hsun Hsieh

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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