Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy

Study Overview
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Brief Summary
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The aim of this study is to evaluate modulation of anti-tumor T cell responses in cancer patients treated by concomitant radiochemotherapy (i-RTCT)

Official Title
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Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy

Conditions
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Lung Cancer, Head and Neck Cancer

Intervention / Treatment
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* Other: Biological samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed NSCLC (Non Small Cell Lung Cancer) or SCLC (small cell lung cancer) OR histologically confirmed Head and neck cancer Patient candidate to a first-line concomitant radiochemotherapy Written informed consent Exclusion Criteria: Sequential radiochemotherapy, exclusive radiotherapy, or stereotactic radiotherapy History of adjuvant radiochemotherapy for cancer treatment Patients under immunotherapy, chemotherapy or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed) HIV, hepatitis C or B virus Patients with any medical or psychiatric condition or disease, Patients under guardianship, curatorship or under the protection of justice.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biological samples<br>Blood samples will be collected at baseline, at J15/J20 after RTCT initiation, and then 1 month, 3 months and 12 months after the end of RTCT treatment, and at disease progression if applicable. Tumor tissues will be collected if available. | Other: Biological samples<br>* blood and tumor tissue sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor antigen specific T-cell responses | tumor antigen specific T-cell responses | up to 12 months after the end of radiochemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| monitoring of immune checkpoints, immune cell death, immune suppressive cells and T-cell polarisation | monitoring of immune checkpoints, immune cell death, immune suppressive cells and T-cell polarisation | up to 12 months after the end of radiochemotherapy | 
| Progression free survival | time interval between the date of initiation of treatment and the date of first progression (local, remote [extent of the disease by RECIST v1.1] second cancer) or death from any cause | date of first progression of the disease (within 2 year after the initiation of the treatment)] | 
| overall survival | time between the date of initiation of treatment and the date of death from any cause | date of death from any cause (within 2 years after the initiation of the treatment) | 
| Quality of life related to health measured by EORTC-QLQC30 | Quality of life related to health measured by EORTC-QLQC30 | from the inclusion to patient death, up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T cells, immunomonitoring, immune checkpoint, chemoradiation