Circulating Tumor Cells (CTCs)NCT07396259
Predicting Clinical Efficacy of Immunotherapy Using Pre-treatment andContinuousMonitoring of PD-L1 TPS/CPS on CTCs, and Immunity Exhaustion Scores
An observational study of Circulating Tumor Cells (CTCs) and Immunotherapy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Circulating Tumor Cells (CTCs), Immunotherapy, PD-L1 Expression
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Feb 2025to 31 Dec 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Head and neck cancer patients scheduled for immunotherapyㄡ
-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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan, City, 333
Hung-Ming Wang, +886975368112, whm526@cgmh.org.tw
About this study
Official title: Dynamically Predicting Clinical Efficacy of Immunotherapy Using Pre-treatment andContinuousMonitoring of PD-L1 TPS/CPS on CTCs, and Immunity Exhaustion Scores - AProspectiveBiomarker Study
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.
Read the detailed description
Head and neck cancer ranks as the fifth to eighth most common cancer globally and is associatedwitha high mortality rate. Since the publication of the KEYNOTE-048 study in 2019, immunotherapyhasbecome the first-line standard treatment for recurrent and metastatic head and neck cancer. However,selecting the appropriate patient population requires CPS (KEYNOTE-048) or TPS (KEYNOTE-040)scores based on tissue samples. Unfortunately, obtaining updated tissue samples can be challenging,especially when disease status changes necessitate treatment adjustments. This is where theimportanceof liquid biopsies as dynamic biomarkers becomes increasingly evident. However, there is still alackofin-depth research on whether liquid biopsies can genuinely predict the efficacy of immunotherapy. According to international consensus, TPS (Tumor Proportion Score) is defined as thenumberofcancer cells expressing PD-L1 divided by the total number of cancer cells, which canbeeasilydetermined using simple immunofluorescence staining. CPS (Combined Positive Score) is definedas100 x [(Number of CTCs expressing PD-L1)+(Number of immune cells expressing PD-L1)]/(CTCnumbers). Thus, analyzing CPS requires staining peripheral immune cells in CTCsamples. Thereisnoconsensus on which immune cells should be included in the analysis. This study aims to definetheCPSscore for peripheral CTCs and evaluate the predictive capability of CTC TPS/CPS in correlatingwithclinical response.
Our team conducted a preliminary analysis of PD-L1 expression in CTC samples toexaminethehypothesis. It investigated the correlation between CPS/TPS expression in CTCs versus PD-L1incancer tissue in early 2024. The results showed a high degree of correlation, indicatingthatthemethodology of this study (CTC TPS and CTC CPS) is feasible. With slight adjustments tobetteralignwith clinical responses, this approach can be practically applied to head and neck cancer patientswhoare about to undergo immunotherapy, thus demonstrating the high feasibility of our research. Therefore, this three-year proposal aims to answer the following important questions: Is thereahighcorrelation between tissue and CTC PD-L1 expression in head and neck cancer patients, andcanitbecalibrated according to actual clinical immunotherapy responses? (2) What is the relationshipbetweenCTC PD-L1 expression and immune exhaustion markers in head and neck cancer patients (hostvs.cancer biomarkers)? (3) Can we establish a dynamic model that continuously predicts andcorrelateswith clinical responses?
- Keywords
- Head and neck cancer, immune checkpoint inhibitors, PD-L1 expression, Liquidbiopsies, CPS, TPS, circulating tumor cells
- Medical subject headings
- Neoplastic Cells, Circulating, Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 years
Secondary outcomes (1)
Progression-Free Survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start25 Feb 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulating Tumor Cells (CTCs)Studies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung-Ming Wang, Principal investigator, Division of Oncology, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396259
- Sponsor's protocol ID
- 202401021
- Status last verified
- Dec 2025
- First submitted
- 1 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamically Predicting Clinical Efficacy of Immunotherapy Using Pre-treatment andContinuousMonitoring of PD-L1 TPS/CPS on CTCs, and Immunity Exhaustion Scores - AProspectiveBiomarker Study
- ClinicalTrials.gov ID
- NCT07396259
- Acronym / sponsor ID
- 202401021
- Keywords
- Head and neck cancer, immune checkpoint inhibitors, PD-L1 expression, Liquidbiopsies, CPS, TPS, circulating tumor cells
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Head and neck cancer ranks as the fifth to eighth most common cancer globally and is associatedwitha high mortality rate. Since the publication of the KEYNOTE-048 study in 2019, immunotherapyhasbecome the first-line standard treatment for recurrent and metastatic head and neck cancer. However,selecting the appropriate patient population requires CPS (KEYNOTE-048) or TPS (KEYNOTE-040)scores based on tissue samples. Unfortunately, obtaining updated tissue samples can be challenging,especially when disease status changes necessitate treatment adjustments. This is where theimportanceof liquid biopsies as dynamic biomarkers becomes increasingly evident. However, there is still alackofin-depth research on whether liquid biopsies can genuinely predict the efficacy of immunotherapy. According to international consensus, TPS (Tumor Proportion Score) is defined as thenumberofcancer cells expressing PD-L1 divided by the total number of cancer cells, which canbeeasilydetermined using simple immunofluorescence staining. CPS (Combined Positive Score) is definedas100 x [(Number of CTCs expressing PD-L1)+(Number of immune cells expressing PD-L1)]/(CTCnumbers). Thus, analyzing CPS requires staining peripheral immune cells in CTCsamples. Thereisnoconsensus on which immune cells should be included in the analysis. This study aims to definetheCPSscore for peripheral CTCs and evaluate the predictive capability of CTC TPS/CPS in correlatingwithclinical response.
Our team conducted a preliminary analysis of PD-L1 expression in CTC samples toexaminethehypothesis. It investigated the correlation between CPS/TPS expression in CTCs versus PD-L1incancer tissue in early 2024. The results showed a high degree of correlation, indicatingthatthemethodology of this study (CTC TPS and CTC CPS) is feasible. With slight adjustments tobetteralignwith clinical responses, this approach can be practically applied to head and neck cancer patientswhoare about to undergo immunotherapy, thus demonstrating the high feasibility of our research. Therefore, this three-year proposal aims to answer the following important questions: Is thereahighcorrelation between tissue and CTC PD-L1 expression in head and neck cancer patients, andcanitbecalibrated according to actual clinical immunotherapy responses? (2) What is the relationshipbetweenCTC PD-L1 expression and immune exhaustion markers in head and neck cancer patients (hostvs.cancer biomarkers)? (3) Can we establish a dynamic model that continuously predicts andcorrelateswith clinical responses?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Head and neck cancer patients scheduled for immunotherapyㄡ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICI responses, concordance to tissue PD-L1 expression
Time frame: 3 years
Use a Published Novel circulaitng tumor cells (CTCs) Identification technologytoexaminePD-L1 expression on CTCs by tumor positive score (TPS, %) and combinedpositivescore(CPS)
1 secondary outcome
Progression-Free Survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hung-Ming Wang principal investigator
Division of Oncology, Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circulating Tumor Cells (CTCs) and Immunotherapy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hung-Ming Wang (+886975368112, whm526@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICI responses, concordance to tissue PD-L1 expression (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.