GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)

NCT05644431 | Recruiting DMC

• 1 other identifier: ET22-201
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

GastroEsophageal Cancer

Keywords

junctional adenocarcinomas; immune microenvironment

Outcome Measures

Primary Outcomes (1)

• Describe Gastric and Gastroesophageal immunological tumor microenvironment

  Spatial, spectral cytometry, and transcriptomic analyses

  At least 36 months following inclusion

Secondary Outcomes (5)

• 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 Outcomes (3)

• 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

Study Arms (1)

Gastric and gastroesophageal junctional adenocarcinomas

Patient under standard chemotherapy in localized and resectable gastric and gastroesophageal junctional adenocarcinomas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, 69000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor samples to be collected include: 1. Mandatory archival FFPE tumor block from initial diagnosis biopsy. 2. Mandatory fresh tumor samples performed before neoadjuvant CT and collected during gastroscopy. 3. Mandatory FFPE tumor samples from surgery specimen and lymph nodes collected during surgery. 4. Optional FFPE tumor block from biopsy or surgery in case of relapse. Blood samples to be collected include: 1. At D1 pre-dose of neoadjuvant CT treatment 2. End of neoadjuvant treatment i.e. within at 1 month after the last neoadjuvant treatment 3. At surgery (within 2 days before or after surgery) 4. At M3, M6, M9, M12, M15, M19, M21, M24, M30, M36

Study Officials

• Clélia COUTZAC, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clélia COUTZAC, MD

CONTACT

04 78 78 60 20; clelia.coutzac@lyon.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 9, 2022
• Study Start: July 19, 2023
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): January 15, 2028
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

FR (1)