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Completed

NCT Number: NCT05941676

Prognostic Immune Biomarkers in HNSCC

Evaluation of the prognostic potential of tumor-infiltrating lymphocytes and PD-L1 expression in non-metastatic squamous cell carcinoma of the head and neck

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Carcinoma Squamous Cell Carcinoma of Head and Neck

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

About this study

The role of the immune system in the process of tumor growth and progression in head and neck (HaN) cancer has become of increasing importance. In the last years, the concept of tumor immune microenvironment (TIME) with the presence of tumor cells (TC) and infiltrating immune cells (IC) has been intensively studied. The results of available clinical studies suggest a positive impact of tumor-infiltrating lymphocytes (TILs) on the prognosis of HNSCC patients and their overall (OS) and cancer specific survivals. Beside TILs, an integral component of TIME is the immunosuppressive activity represented by inhibitory signalling molecules expressed on tumor cells (TCs) and immune cells (ICs).

One of these molecules is programmed death-ligand 1 (PD-L1), which inhibits the cytotoxic immune response mediated by T-lymphocytes.

The aim of this observational cohort study is to assess the prognostic potential of novel immune biomarkers in patients with HNSCC tumors stage I-IVb treated with radical radiotherapy and radiochemotherapy. Specifically, the association between high and low TILs infiltration and OS and cancer specific survival parameters will be investigated. As well as the association between high and low PD-L1 expression and OS and cancer specific survival parameters will be investigated.

This is a non-interventional study conducted in one institution - Department of oncology, University hospital Ostrava. The tumor immunoprofile defined by the presence of immune biomarkers (TIL, PD-L1) will be evaluated in each patient from biopsy specimens in representative hematoxylin and eosin stained sections by immuno-histochemistry. The Cox proportional risk model will be used to estimate the prognostic potential of each of the biomarker.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tumour immunoprofile evaluation

Diagnostic Test

Tumour immunoprofile evaluation will be performed in patients with head and neck cancer.

Primary outcomes

  1. Overall survival (OS)

    Time frame: 24 months

    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

  1. Disease-specific survival (DSS)

    Time frame: 24 months

    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.

  2. Disease-free survival (DFS)

    Time frame: 24 months

    Disease-free survival calculated from the date of initiation of radiotherapy to the date of detection of any recurrence, or date of death from any cause or date of the last follow-up visit. Patients without tumor recurrence are censored at the last follow-up contact.

  3. Locoregional-free survival (LRFS)

    Time frame: 24 months

    Locoregional-free survival calculated from the date of initiation of radiotherapy to the date of detection of clinical, radiological and/or pathological evidence of recurrence or tumor progression at the primary site or in the regional nodal area, or date of death from any cause or date of the last follow-up visit. Patients without tumor recurrence are censored at the last follow-up contact.

  4. Distant metastatic-free survival (DMFS)

    Time frame: 24 months

    Distant metastatic-free survival calculated from the date of initiation of radiotherapy to the date of detection of distant metastasis of the tumor, or date of death from any cause or date of the last follow-up visit. Patients without tumor recurrence were censored at the last follow-up contact.

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Official study title

Evaluation of the Prognostic Potential of New Immune Biomarkers in Non-metastatic Squamous Cell Carcinoma of the Head and Neck

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jul 12, 2023
Registry last updated
Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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