Clinical trial NCT05644431: GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)
Official title: A Prospective Clinicobiological Cohort Study Aiming to Decipher Tumor Immune Microenvironment Evolution Under Standard Chemotherapy in Localized and Resectable Gastric and Gastroesophageal Junctional Adenocarcinomas
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: GastroEsophageal Cancer
Keywords: junctional adenocarcinomas
immune microenvironment
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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 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.

Primary outcomes:
measure: Describe Gastric and Gastroesophageal immunological tumor microenvironment
timeFrame: At least 36 months following inclusion
Secondary outcomes:
measure: Understand the evolution of the immune tumor microenvironment and its spatial structuration through standard neoadjuvant chemotherapy.
timeFrame: At least 36 months following inclusion
measure: Characterize the evolution of the immune tumor environment profiles and organization between responder and non-responder patients under standard neoadjuvant treatment.
timeFrame: At least 36 months following inclusion
measure: Characterize the immune profile in lymph nodes after surgery (lymphadenectomy) between responder and non-responder patients to neoadjuvant under standard neoadjuvant treatment.
timeFrame: At least 36 months following inclusion
measure: Assess the phenotype and functions of circulating immunes cells
timeFrame: At least 36 months following inclusion
measure: Perform integrative analysis combining spatial, molecular, single cell RNAseq, and spectral flow cytometry analysis on the immunological tumor environment in matched tumor tissues longitudinally
timeFrame: At least 36 months following inclusion
Other outcomes:
measure: 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
timeFrame: At least 36 months following inclusion
measure: assess MRD using liquid biopsies over standard neoadjuvant and adjuvant treatment.
timeFrame: At least 36 months following inclusion
measure: 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).
timeFrame: At least 36 months following inclusion
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Leon Berard
name: Clélia COUTZAC, MD
role: PRINCIPAL_INVESTIGATOR
References: