A Prospective Clinicobiological Cohort Study Aiming to Decipher Tumor Immune Microenvironment Evolution Under Standard Chemotherapy in Localized and Resectable Gastric and Gastroesophageal Junctional Adenocarcinomas

Centre Leon Berard1 site in 1 country50 target enrollmentJuly 19, 2023

ConditionsGastroEsophageal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: GastroEsophageal Cancer
Sponsor: Centre Leon Berard
Enrollment: 50
Locations: 1
Primary Endpoint: Describe Gastric and Gastroesophageal immunological tumor microenvironment
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 19, 2023

End Date

January 15, 2028

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Centre Leon Berard

Responsible Party

Sponsor

Eligibility Criteria

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
•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.

Outcomes

Primary Outcomes

Describe Gastric and Gastroesophageal immunological tumor microenvironment

Time Frame: At least 36 months following inclusion

Spatial, spectral cytometry, and transcriptomic analyses

Secondary Outcomes

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)
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)