GastrOesophageal Tumor, Immune Microenvionnment (GOTIM) (GOTIM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: GastroEsophageal Cancer

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Clélia COUTZAC, MD; Phone Number: 04 78 78 60 20; Email: clelia.coutzac@lyon.unicancer.fr

Study Locations

• France
  • Lyon, France, 69000
    • Recruiting
    • Centre Leon Berard
    • Contact: Clélia COUTZAC, MD; Phone Number: 04 78 78 60 20; Email: clelia.coutzac@lyon.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with localised non-metastatic operable gastric and oeasogatric junction adenocarcinoma, stage IB à III, treated with standard neoadjuvant therapy and by surgery.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Gastric and gastroesophageal junctional adenocarcinomas; Patient under standard chemotherapy in localized and resectable gastric and gastroesophageal junctional adenocarcinomas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe Gastric and Gastroesophageal immunological tumor microenvironment	Spatial, spectral cytometry, and transcriptomic analyses	At least 36 months following inclusion

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Time Frame
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
assess MRD using liquid biopsies over standard neoadjuvant and adjuvant treatment.	At least 36 months following inclusion
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

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: Clélia COUTZAC, MD, Centre Leon Berard

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2023
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): January 15, 2028

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: junctional adenocarcinomas; immune microenvironment
• Other Study ID Numbers: ET22-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No