Head and Neck Advanced Research for Multi-Omics and Optimized Immunotherapy

Recruiting now

Conditions studied: Head and Neck Cancer

In brief

Head and neck squamous cell carcinoma is a heterogeneous cancer with varying prognoses depending on anatomical location and characteristics, and advanced cancers have a poor prognosis. This study aimed to examine changes in the tumor microenvironment and systemic immune system before and after combination therapy with immune checkpoint inhibitors, the standard first-line treatment for head and neck cancer. The rationale for this research and development project is as follows: 1. While immune checkpoint inhibitors have improved survival rates for head and neck cancer patients, they are only effective in approximately 15% of patients. Because biomarkers predicting treatment response have not yet been clearly identified, targeting target patient populations is challenging. 2. While numerous studies have examined the tumor microenvironment in head and neck cancer, no studies have spatially compared dynamic changes before and after immune checkpoint inhibitor treatment using paired tissue and blood biopsies. Therefore, the specific treatment mechanisms remain unclear. 3. Little is known about how changes in the tumor microenvironment are reflected in the peripheral blood, making noninvasive treatment response monitoring difficult. 4. Immune checkpoint inhibitor treatment is known to enhance the efficacy of subsequent taxane-based chemotherapy, but the mechanism remains unknown. Therefore, we aim to explore biomarkers that predict treatment response to combination therapy with immune checkpoint inhibitors and cytotoxic chemotherapy in patients with advanced/metastatic head and neck cancer and develop personalized treatment strategies.

Key facts

Study ID

NCT07211139

Run by

Samsung Medical Center

People needed

30

Starts

2025-07-08

Expected to finish

2027-12-31

Last updated by the study team

2025-10-07

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)
• Received first-line combination therapy with immune checkpoint inhibitor and cytotoxic chemotherapy
• Availability of tumor tissue samples at Samsung Medical Center
• p16 and PD-L1 expression status evaluable within the institution
• Age ≥ 20 years
• Ability to understand the study purpose and provide written informed consent

You may not qualify if…

• Not meeting the inclusion criteria
• Considered ineligible for enrollment at the discretion of the investigator

Where it is running

• Samsung Medical Center — Seoul, Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.