Understanding the immune environment in gastroesophageal cancer
A Prospective Clinicobiological Cohort Study Aiming to Decipher Tumor Immune Microenvironment Evolution Under Standard Chemotherapy in Localized and Resectable Gastric and Gastroesophageal Junctional Adenocarcinomas
This study looks at how the immune system reacts in patients with stomach and gastroesophageal junction cancer who are receiving chemotherapy to see if it can help improve their treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Leon Berard Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT05644431 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the immune tumor microenvironment in patients with resectable gastric and gastroesophageal junction adenocarcinomas undergoing standard neoadjuvant chemotherapy. It will involve monitoring minimal residual disease (MRD) during both neoadjuvant and adjuvant therapy phases. The study will collect data from patients treated at Centre Léon Bérard, focusing on the immune response and its implications for treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histologically confirmed non-metastatic resectable gastric or gastroesophageal junction adenocarcinoma, staged IB to III.
Not a fit: Patients with contraindications to blood sampling or those with additional malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of the immune landscape in gastroesophageal cancer, potentially leading to improved treatment strategies.
How similar studies have performed: While the specific approach of this study is novel, similar studies have shown promise in understanding the immune microenvironment in other cancers.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lyon
- Centre Léon Bérard — Lyon, France (Recruiting)
Study contacts
- Principal investigator: Clélia COUTZAC, MD — Centre Leon Berard
- Study coordinator: Clélia COUTZAC, MD
- Email: clelia.coutzac@lyon.unicancer.fr
- Phone: 04 78 78 60 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.