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Recruiting Phase 2 NCT06482788

Perioperative Treatment of Resectable Adenocarcinoma of Esophagogastric Junction by Immunotherapy (Adebrelimab) Combined With Chemotherapy (XELOX): a Prospective, Single-center, Feasibility Study

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Trial Parameters

Condition Esophagogastric Junction Adenocarcinoma
Sponsor Ruijin Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 26
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-05-22
Completion 2025-05-31
Interventions
Adebrelimab (anti-PD-L1) + XELOX

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Brief Summary

The purpose of this study is to explore the effectiveness and safety of immunotherapy (Adebrelimab, a PD-L1 inhibitor) combined with standard chemotherapy (XELOX) in the perioperative treatment of resectable esophagogastric junction adenocarcinoma.

Eligibility Criteria

Inclusion Criteria: * Sign on the informed consent form (ICF) * Histologically confirmed esophagogastric junction Adenocarcinoma (AEG, Type Siewert I/II/ III), the stage is locally advanced cT1b-2N+ or T3-4Nany that the investigator judges it to be resectable (1. CT or MRI assessment shows no invasion of adjacent organs or tissues, 2. No peritoneal metastasis occurs, 3. There are surgical indications) (Note: If bone lesions are suspected, a bone scan is required; if peritoneal carcinomatosis is suspected, laparoscopy is required to confirm; if T3-T4 subjects have diffuse tissue types, diagnostic laparoscopy is also required)) * No previous systematic treatment * At least one measurable lesion according to RECIST 1.1. * ECOG PS: 0-1 * The functions of important organs meet the following requirements:Absolute neutrophil count ≥ 1.5 × 109/L; Platelet ≥ 100 × 109/L; Hemoglobin ≥ 90g / l; ALT and AST ≤ 2.5 times ULN; TBIL ≤ 1.5 times ULN; Serum creatinine ≤ 1.5 times ULN or creatinine clear

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