PD-L1 Expression on CTCs in HNSCC Patients Underwent Curative CCRT

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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Squamous Cell Carcinoma; Circulating Tumor Cell

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Pei-Wei H, MD; Phone Number: 2517 +88633281000; Email: freewind_05@yahoo.com.tw

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung memorial hospital
    • Contact: Pei-Wei Huang, MD; Phone Number: 2517 +8863281000; Email: freewind_05@yahoo.com.tw
    • Principal Investigator: Pei-Wei Huang, MD
    • Sub-Investigator: Hung-Ming Wang, MD
    • Sub-Investigator: Chia-Hsun Hsieh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Stage III-IV head and neck squamous cell carcinoma patients, except those with P16 positive oropharyngeal cancer patients, who are going to do curative platinum-based CCRT.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival rate	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival rate	1 year
Loco-regional recurrence rate	1 year
Distant metastasis rate	1 year

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Neoplastic Cells, Circulating
• Other Study ID Numbers: 202002049B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No