GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)

Léon Bérard Center

Status: Enrolling

Conditions: GastroEsophageal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05644431

ET22-201

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Gastric and gastroesophageal junctional adenocarcinomas

Description:

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