GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)

GastroEsophageal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05644431
• Other study ID #: ET22-201
• Status: Recruiting
• Start date: July 19, 2023
• Est. completion date: January 15, 2028

Study information

• Verified date: August 2023
• Source: Centre Leon Berard
• Contact: Clélia COUTZAC, MD
• Phone: 04 78 78 60 20
• Email: clelia.coutzac[@]lyon.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 15, 2028
• Est. primary completion date: January 15, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• GastroEsophageal Cancer

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	assess MRD using liquid biopsies over standard neoadjuvant and adjuvant treatment.		At least 36 months following inclusion
Other	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
Primary	Describe Gastric and Gastroesophageal immunological tumor microenvironment	Spatial, spectral cytometry, and transcriptomic analyses	At least 36 months following inclusion
Secondary	Understand the evolution of the immune tumor microenvironment and its spatial structuration through standard neoadjuvant chemotherapy.		At least 36 months following inclusion
Secondary	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
Secondary	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
Secondary	Assess the phenotype and functions of circulating immunes cells		At least 36 months following inclusion
Secondary	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