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NCT07692477Not yet recruiting

Molecular Characterization of Tumor-Microenvironment Interactions to Predict Drug Resistance in Gastric and GEJ Adenocarcinoma

Molecular Characterization of Tumor-Microenvironment Interactions to Predict Drug Resistance to Perioperative Treatment in Patients With Gastric and Gastroesophageal Junction Adenocarcinoma

Source: ClinicalTrials.gov · Last updated 9 Jul 2026

Brief summary (registry, in English)

Surgical resection remains the only curative option for resectable gastric cancer, but perioperative FLOT chemotherapy is associated with substantial rates of chemoresistance and recurrence, largely driven by marked tumor heterogeneity. Recent data from the MATTERHORN phase III trial have shown that adding durvalumab to perioperative FLOT improves pathological complete response and survival, supporting this combination as a new standard of care for resectable gastric and gastroesophageal junction adenocarcinoma. This observational multicenter study aims to characterize angiogenic and immune profiles within the tumor microenvironment and peripheral blood, in order to identify cellular and molecular signatures associated with response or resistance to perioperative FLOT plus durvalumab. Longitudinal biospecimen collection (PBMCs, serum, plasma, endoscopic biopsies, surgical specimens) will be integrated with multiparametric flow cytometry, single-cell transcriptomics and TCR/BCR sequencing, immunohistochemistry, pathomics and multiplex immunoassays, to provide mechanistic insights and potential predictive biomarkers.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
250 (estimated)
First submitted
2 Jul 2026
Start date
1 Sept 2026
Primary completion date
1 Sept 2027
Lead sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
NCT number
NCT07692477

What you commit to

  • Study type: Observational
  • Planned participants: 250
  • From 1 Sept 2026 to the primary completion date, 1 Sept 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Presence of another active malignant disease
  • Advanced or metastatic gastric/GEJ cancer not eligible for surgical treatment

Other

  • Inability or unwillingness to provide written informed consent

Who the study is looking for

  • Histologically confirmed adenocarcinoma of the stomach (gastric cancer, GC) or gastroesophageal junction (GEJ)
  • Operable, locally advanced disease (T \>= 2 and/or node-positive) according to AJCC 8th edition staging
  • Candidate for perioperative chemotherapy with FLOT regimen combined with durvalumab, as per clinical practice
  • Age \>= 18 years
  • Provision of written informed consent prior to any study-specific procedure

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.