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

Centre Hospitalier Universitaire de Besancon4 sites in 1 country220 target enrollmentMay 29, 2017

Overview

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

Registry

clinicaltrials.gov

Start Date

May 29, 2017

End Date

November 29, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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.

tumor antigen specific T-cell responses

Time Frame: up to 12 months after the end of radiochemotherapy

tumor antigen specific T-cell responses

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(date of first progression of the disease (within 2 year after the initiation of the treatment)])
Quality of life related to health measured by EORTC-QLQC30(from the inclusion to patient death, up to 1 year)
overall survival(date of death from any cause (within 2 years after the initiation of the treatment))