Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 : Immune Response

Study Overview
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Brief Summary
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This study will follow-up immune cell populations, secreted factors and released nanovesicles in the blood before, during and after high dose radiation therapy which should give new information of the efficacy of the hypofractionated high dose radiation therapy and a rationale for adjuvant immunotherapy.

Detailed Description
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Patient information and collection of a signed informed consent form Clinical data collection Blood samples of 35 mL: after registration, prior to the first fraction of radiotherapy within 15 minutes after the administration of the 1st, the 2nd and the 3rd radiotherapy sessions one week, 3 months, 6 months, 9 months and 12 months after the last radiotherapy session Storage of the blood samples at ambient temperature Transportation of the samples to the Institute of Biology of Lille (IBL) - CNRS UMR8161 for analysis Destruction of the samples at the end of the analysis

Official Title
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Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 : Immune Response

Conditions
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Carcinoma, Hepatocellular, Colorectal Neoplasms, Melanoma, Kidney Neoplasms

Intervention / Treatment
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* Procedure: Blood samples collection before radiotherapy
* Procedure: Blood samples collection during radiotherapy
* Procedure: Blood samples collection after radiotherapy
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient requiring a hypofractionated irradiation (≥ 3 fractions, dose ≥ 9 Gy per fraction) either for : hepatocellular carcinoma or hepatic lesion of metastatic Colorectal Cancer, metastasis from melanoma or renal cancer, Age ≥ 18 years old, Registered with a social security system, Signed written informed consent. Exclusion Criteria: Patient treated by chemotherapy, targeted or immunotherapy within 21 days before the first sampling, Pregnant or breastfeeding woman, Patient under guardianship or tutorship.

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: Blood samples collection<br>Nine blood samples will be collected in each patient before, during and after radiotherapy treatment. Interventions : Blood samples collection before radiotherapy (T0) Blood samples collection during radiotherapy (T1-T3) Blood samples collection after radiotherapy (T4-T8) | Procedure: Blood samples collection before radiotherapy<br>* Nine blood samples (35 mL each) will be collected in each patient before, during and after radiotherapy treatment. Before radiotherapy: Sample T0: after registration, in the days running up to the administration of the first fraction of radiotherapy<br>Procedure: Blood samples collection during radiotherapy<br>* Sample T1: within 15 minutes after the administration of the first fraction, Sample T2: within 15 minutes after the administration of the second fraction, Sample T3: within 15 minutes after the administration of the third fraction<br>Procedure: Blood samples collection after radiotherapy<br>* Sample T4: one week after the end of the radiotherapy, Samples T5 to T8: respectively 3 months, six months, 9 months and 12 months after the end of the radiotherapy.<br>Radiation: Radiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyse of immunological parameters, decription of secreted markers and nanovesicles production | Description and evolution of cell fraction, quantification of immune cells, verification of the presence and evolution of activation markers and quantification of secreted exosomes ; before, during and after radiotherapy | from baseline to 1 year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell viability, determined by number of live/dead cells present | Cell viability and cell proliferation | from baseline to 1 year follow up | 
| Progression-free rate | progression-free rate at 12 months | from baseline to 1 year follow up | 
| Number of Participants with Adverse Events related to radiotherapy | adverse effects (acute toxicity) according to CTCAE-NCI | from baseline to 1 year follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver metastases of colorectal cancer, metastases of melanoma or renal cancer