Clinical trial · Observational
Prognostic Immune Biomarkers in HNSCC
Evaluation of the Prognostic Potential of New Immune Biomarkers in Non-metastatic Squamous Cell Carcinoma of the Head and Neck
NCT05941676CI-TRIAL-00067946completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluation of the prognostic potential of tumor-infiltrating lymphocytes and PD-L1 expression in non-metastatic squamous cell carcinoma of the head and neck
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumour immunoprofile evaluation | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Head and neck carcinoma patients
- description
- Head and neck carcinoma patients will be enrolled in this study group.
- interventionNames
- Diagnostic Test: Tumour immunoprofile evaluation
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- 24 months
- description
- Overall survival measured in months - calculated from the date of initiation of radiotherapy to the date of death from any cause or the date of the last follow-up visit.
Secondary outcomes (4)
- measure
- Disease-specific survival (DSS)
- timeFrame
- 24 months
- description
- Disease-specific survival calculated from the date of initiation of radiotherapy to the date of cancer death, or date of the last follow-up visit. Patients who died from causes other than HNSCC are censored at the time of death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with non-metastatic squamous-cell head and neck cancer (HNSCC) stage I-IVb indicated for curative/radical treatment * Histologically verified squamous cell carcinoma including HPV-positive carcinomas * Tumor site: oropharynx, larynx, hypopharynx, oral cavity, nasal cavity * Treatment modality - radiotherapy or radiochemotherapy * Presence of immune biomarkers in the tissue - tumor-infiltrating lymphocytes (TILs) and/or PD-L1 expression * Sufficient data on patient follow-up Exclusion Criteria: * Histological type other than squamous cell carcinoma * Paranasal sinus tumors, thyroid and nasopharyngeal carcinomas, salivary gland tumors, mucosal melanoma, skin carcinoma, lymphomas, and occult primary tumors * Synchronous malignancies or recurrent disease * The previous use of radiotherapy * The presence of distant metastatic disease * Missing or inadequate follow-up data * The inability to evaluate biomarkers (TILs or PD-L1) in a histological tissue sample.
References
Publications (2)
- RESULTBlazek T, Petras M, Knybel L, Cvek J, Soumarova R. Programmed Cell Death Ligand 1 Expression on Immune Cells and Survival in Patients With Nonmetastatic Head and Neck Cancer: A Systematic Review and Meta-analysis. JAMA Netw Open. 2023 Mar 1;6(3):e236324. doi: 10.1001/jamanetworkopen.2023.6324. PMID 37000447
- DERIVEDBlazek T, Petras M, Hurnik P, Matousek P, Knybel L, Cermakova ZZ, Stembirek J, Cvek J, Soumarova R. High PD-L1 expression on immune cells along with increased density of tumor-infiltrating lymphocytes predicts a favorable survival outcome for patients with loco-regionally advanced head and neck cancer: early results from a prospective study. Front Oncol. 2024 Apr 4;14:1346793. doi: 10.3389/fonc.2024.1346793. eCollection 2024. PMID 38638854