Prognostic Immune Biomarkers in HNSCC

Completed

• Conditions: Squamous Cell Carcinoma; Head and Neck Cancer
• Interventions: Diagnostic Test: Tumour immunoprofile evaluation

• Registration Number: NCT05941676
• Lead Sponsor: University Hospital Ostrava

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2022-08-30
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-03
• Last Update Submitted: 2023-07-03
• Study First Posted: 2023-07-12
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Head and neck carcinoma patients	Tumour immunoprofile evaluation	Head and neck carcinoma patients will be enrolled in this study group.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	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 Outcome Measures

Name	Time	Method
Locoregional-free survival (LRFS)	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.
Disease-specific survival (DSS)	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.
Disease-free survival (DFS)	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.
Distant metastatic-free survival (DMFS)	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.

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia