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Clinical Trials/NCT05008796
NCT05008796
Unknown
Not Applicable

Correlation Between PD-L1 Expression on Circulating Tumor Cells and Outcomes in Head and Neck Cancer Patients Treating With Curative Concurrent Chemo-radiotherapy

Chang Gung Memorial Hospital1 site in 1 country50 target enrollmentAugust 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head and Neck Squamous Cell Carcinoma
Sponsor
Chang Gung Memorial Hospital
Enrollment
50
Locations
1
Primary Endpoint
Progression-free survival rate
Last Updated
4 years ago

Overview

Brief Summary

Head and neck squamous cell carcinoma (HNSCC) is the 4th highest incidence of cancer and 6th of cancer death of the males in Taiwan. Because the patients were mainly middle-aged male, the disease eventually resulted in a huge loss of labor force, productivity and a huge burden of family supports and medicinal costs. Unfortunately, the incidence and death of HNSCC seemed to be increasing in Taiwan. Currently, the primary treatments of HNSCC are mainly surgery, radiotherapy, chemotherapy or targeted therapy or concurrent chemoradiotherapy. Immune checkpoint inhibitors become an emerging treatment in recent days. However, how to select adequate patient by using biomarkers remains an unsolved problem. Therefore, investigator have developed a new method for isolation and detection of circulating tumor cells (CTCs) in HNSCC patients. Moreover, the expression of immune markers (such as PD-L1, PD-L2, PD-1) on CTCs or immune cells might be a good target to study. Investigator's preliminary data found CTCs and circulating cancer stem-like cells but not PD-1 expression levels on peripheral T cells in patients with recurrence or metastasis HNSCC did not associated with overall survival. Therefore, investigators are wondering if PD-L1 more specific due to it expression on cancer cells. Therefore, in the 3-year project, investigators will utilize developing device and protocol in first year and then enroll 40 freshly diagnosed participants with head and neck cancer at stage III-IV with intent to receive curative concurrent chemo-radiotherapy (CCRT), and then analyze CTCs, PD-L1 expression levels on CTCs. Blood sample will be taken before, during (definition: 3-6 weeks after start RT) and after (definition: 4 +/-2 weeks after complete CCRT) completion of CCRT. Investigators will also enroll 10 health participants and taking blood sample for 3 times and follow up. Further statistical tests with clinical conditions (disease status, treatment effects, progression or distant metastasis and death) will be performed to elucidate their clinical significance. Hopefully, investigators will clarify the correlation between clinical outcomes and expression of PD-L1 on CTCs in head and neck patients. This could be a new biomarker for clinical cancer care.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
July 31, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with head and neck squamous cell carcinoma with age at diagnosis ≥ 20 years
  • Stage III-IV according to AJCC 8th ed.
  • Intent to receive curative concurrent chemoradiotherapy (CCRT)
  • 10 healthy donors without any cancer diagnosis within 5 years

Exclusion Criteria

  • P16 positive oropharyngeal cancer
  • Non-Platinum based CCRT
  • Previous diagnosed with cancer within 3 years
  • Synchronous cancer
  • Poor compliance, cannot cooperate for blood sampling for CTCs isolation as time schedule or clinical treatment or follow-up

Outcomes

Primary Outcomes

Progression-free survival rate

Time Frame: 1 year

Secondary Outcomes

  • Distant metastasis rate(1 year)
  • Loco-regional recurrence rate(1 year)
  • overall survival rate(1 year)

Study Sites (1)

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