NCT05644431招募中不适用
A Prospective Clinicobiological Cohort Study Aiming to Decipher Tumor Immune Microenvironment Evolution Under Standard Chemotherapy in Localized and Resectable Gastric and Gastroesophageal Junctional Adenocarcinomas
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Describe Gastric and Gastroesophageal immunological tumor microenvironment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
Describe Gastric and Gastroesophageal immunological tumor microenvironment
时间窗: At least 36 months following inclusion
Spatial, spectral cytometry, and transcriptomic analyses
次要结局
- 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)
- 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)
研究者
研究点 (1)
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