GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)
ConditionGastroEsophageal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Leon Berard
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: Gastric and gastroesophageal junctional adenocarcinomas
Trial outcomes
Primary outcomes
1
Describe Gastric and Gastroesophageal immunological tumor microenvironment
Spatial, spectral cytometry, and transcriptomic analyses
Time frame
At least 36 months following inclusionSecondary outcomes
1
Understand the evolution of the immune tumor microenvironment and its spatial structuration through standard neoadjuvant chemotherapy.
Time frame
At least 36 months following inclusion2
Characterize the evolution of the immune tumor environment profiles and organization between responder and non-responder patients under standard neoadjuvant treatment.
Time frame
At least 36 months following inclusion3
Characterize the immune profile in lymph nodes after surgery (lymphadenectomy) between responder and non-responder patients to neoadjuvant under standard neoadjuvant treatment.
Time frame
At least 36 months following inclusion4
Assess the phenotype and functions of circulating immunes cells
Time frame
At least 36 months following inclusionOther outcomes
1
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
Time frame
At least 36 months following inclusion2
assess MRD using liquid biopsies over standard neoadjuvant and adjuvant treatment.
Time frame
At least 36 months following inclusion3
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).
Time frame
At least 36 months following inclusionSponsors and contacts
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Source ClinicalTrials.gov