An observational study in Head and Neck Cancers- Squamous Cell, Head and Neck Cancer Metastatic and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by National Taiwan University Hospital · Observational
The goal of this observational study is to learn about the prognostic value of circulation tumor emboli (CTM) in recurrent/metastatic head and neck cancer patients and also the changes of tumor microenvironment by different treatment modalities and drugs. The main questions it aims to answer are:
Patients with recurrent/metastatic head and neck cancer will be included after informed consent and investigators will collect blood samples for analysis from them under the treatment provided by their primary care physicians.
Head and neck cancer, including oral, oropharyngeal and hypopharyngeal cancer, is the third most common type of cancer and the fourth leading cause of death of cancer among male patients in Taiwan according to the 2021 cancer registry. Despite surgery and adjuvant concurrent chemoradiotherapy (CCRT) for locally advanced head and neck cancer, there still were 20 to 30 % of patients who had recurrent disease within 2 years. For patients who were not suitable to receive surgery, the progression free survival was even worse, especially for those with HPV negative cancer In Taiwan, there is a special category of head and neck cancer which is associated with betel nut use and the molecular basis of this type of cancer is different. This is the most important reason why studies should be done in Taiwanese population.
In recent years, numbers of studies have confirmed that circulating tumor cells (CTCs) play a key role in the process of tumor metastasis and recurrence. The collection and analysis of CTCs is expected to provide patients with important information that was not easily available in the past and assist in planning of follow-up treatments strategy. However, CTCs research still faces many challenges, including: (1) The current clinical CTCs detection platform cannot tell whether the isolated cells contain the CTCs cluster or CTM from patient's liquid biopsy; (2) Lack of analytical technology to identify metastasis risk from the isolated CTCs and (3) how to analyze the immune microenvironment in CTM and apply it to formulate therapeutic strategy of the follow-up treatment.
As mentioned above, there are a group of patients who would experience recurrence locally or distant metastases within a short period of time after curative treatment. First, investigators want to establish a platform to predict recurrence and prognosis. By using the number of circulating tumor cells (CTCs), circulating tumor emboli (CTM) and INF-γ level incorporated with clinical factors to correlate with patient prognosis. Second, investigators want to evaluate the component of NK cells in CTM, and elucidate their correlation with different risk factors, including HPV status, smoking and betel nut use, treatment modalities, treatment drugs and patient prognosis.
This research will elucidate not only prognostic value of CTM, but also the changes of tumor microenvironment by different treatment modalities and drugs.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 236 observational studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Recurrent/Metastatic squamous cell carcinoma of the head and neck
Inclusion Criteria: must fulfill with all the items below
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient inclusion criteria, must fulfill with all the items below 1\. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2.\>=20 years old. 3\. had pathologically confirmed squamous cell carcinoma of the oropharynx, oral cavity, hypopharynx, or larynx that was recurrent or metastatic and not curable by local therapy. 4\. had at least one tumor lesion measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 5. Medical records during treatment are available.
Progression-free survival (PFS)
The time from diagnosis as non-curable disease to clinically (physical examination or radiographically) confirmed disease progression or death from any cause, whichever came first.
Time frame: From enrollment to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall survival (OS)
The time from diagnosis as non-curable disease to death from any cause
Time frame: From date of enrollment until the date of death from any cause, whichever came first, assessed up to 60 months
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: starting 6 months after publication
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2027, 35 months after the start.
Of 108 non-industry observational studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 132. This study's planned 35 months is below that.
Counting every sponsor, half of 118 studies reached it within 81 months; a quarter within 29 and three quarters within 132.
How these figures are worked out, and which studies are left out of them.
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