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

NCT07396259 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-02-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Hung-Ming Wang · Division of Oncology, Chang Gung Memorial Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-25
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07396259 on ClinicalTrials.gov