GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)

Recruiting

• Conditions: GastroEsophageal Cancer

• Registration Number: NCT05644431
• Lead Sponsor: Centre Leon Berard

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-09
• Study Start: 2023-07-19
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30
• Primary Completion: 2028-01-15
• Study Completion: 2028-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Describe Gastric and Gastroesophageal immunological tumor microenvironment	At least 36 months following inclusion	Spatial, spectral cytometry, and transcriptomic analyses

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre Léon Bérard; 🇫🇷 Lyon, France