GastroEsophageal Cancer
Conditions
Keywords
junctional adenocarcinomas, immune microenvironment
Brief summary
This trial is a prospective, monocentric, non-therapeutic, interventional cohort study aiming to decipher the immune TME through standard neoadjuvant CT in resectable G/GEJ adenocarcinomas. This study will also longitudinally monitor MRD during neoadjuvant and adjuvant therapy.
Interventions
None listed
Sponsors
Centre Leon Berard
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patient \> 18 years of age on day of signing informed consent. * Histologically proven non-metastatic resectable gastric and gastroesophageal junction adenocarcinoma, Stage IB to III to be treated with standard neoadjuvant treatment. * Surgery of primary tumor to be done at Centre Léon Bérard. * Availability of archival FFPE tumor block from initial diagnosis with at least 20% of tumor cells. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2. * Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol. * Patients must be covered by a medical insurance.
Exclusion criteria
* Any condition contraindicated with blood sampling procedures required by the protocol. * Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer * Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure. * Pregnant or breast-feeding woman.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Describe Gastric and Gastroesophageal immunological tumor microenvironment | At least 36 months following inclusion | Spatial, spectral cytometry, and transcriptomic analyses |
Secondary
| Measure | Time frame |
|---|---|
| Characterize the evolution of the immune tumor environment profiles and organization between responder and non-responder patients under standard neoadjuvant treatment. | At least 36 months following inclusion |
| Characterize the immune profile in lymph nodes after surgery (lymphadenectomy) between responder and non-responder patients to neoadjuvant under standard neoadjuvant treatment. | At least 36 months following inclusion |
| Assess the phenotype and functions of circulating immunes cells | At least 36 months following inclusion |
| Perform integrative analysis combining spatial, molecular, single cell RNAseq, and spectral flow cytometry analysis on the immunological tumor environment in matched tumor tissues longitudinally | At least 36 months following inclusion |
| Understand the evolution of the immune tumor microenvironment and its spatial structuration through standard neoadjuvant chemotherapy. | At least 36 months following inclusion |
Other
| Measure | Time frame |
|---|---|
| assess the correlation between ctDNA analysis and i) patient clinical outcome and ii) current prognostic factors (for instance TNM stage with ypTN stage in gastric and oesogastric junction carcinomas). | At least 36 months following inclusion |
| assess MRD using liquid biopsies over standard neoadjuvant and adjuvant treatment. | At least 36 months following inclusion |
| evaluate in patient-derived tumor fragment (ex vivo platform of Centre Léon Bérard), the impact of immune checkpoint inhibitors (ICI) selected from our previous data in order to develop and improve therapeutic strategy | At least 36 months following inclusion |
Countries
France
Contacts
Primary ContactClélia COUTZAC, MD
Outcome results
None listed