GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)

Launched by CENTRE LEON BERARD · Dec 1, 2022

Keywords

ClinConnect Summary

The GOTIM clinical trial is studying the immune environment of gastroesophageal cancer, specifically focusing on patients with resectable gastric and gastroesophageal junction adenocarcinomas. This trial aims to understand how the body's immune system interacts with the tumor during standard treatment before surgery, known as neoadjuvant chemotherapy. Researchers will also track a specific measure called minimal residual disease (MRD) to see how well the treatment is working over time.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of non-metastatic gastric or gastroesophageal junction cancer that can be surgically removed. They should also be in good overall health, as determined by their performance status, and have access to their tumor samples from the initial diagnosis. Patients can expect to undergo regular visits and procedures related to the trial, and their participation will help researchers gain valuable insights into how to improve treatments for this type of cancer. It’s important to note that pregnant or breastfeeding women and those with certain other medical conditions may not be able to participate.

Gender

ALL

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.

Trial Officials