NCT07211139 Head and Neck Advanced Research for Multi-Omics and Optimized Immunotherapy
| NCT ID | NCT07211139 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samsung Medical Center |
| Condition | Head and Neck Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-07-08 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-07-08 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Not meeting the inclusion criteria * Considered ineligible for enrollment at the discretion of the investigator
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07211139 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07211139 currently recruiting?
Yes, NCT07211139 is actively recruiting participants. Contact the research team at lisakjy@gmail.com for enrollment information.
Where is the NCT07211139 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07211139 clinical trial?
NCT07211139 is sponsored by Samsung Medical Center. The trial plans to enroll 30 participants.
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