Adebrelimab Combined With SOX Regimen in Preoperative Neoadjuvant Transformation Therapy for Locally Advanced Gastric Adenocarcinoma

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2023
Abstract Objective: Adebrelimab is a PD-L1 inhibitor. The aim of this trial is to evaluate the safety and efficacy of adebrelimab combined with SOX regimen for preoperative neoadjuvant therapy in locally advanced gastric adenocarcinoma. Methods and analysis: This study is a prospective single-center, two-arm, double-blind and randomized controlled clinical trial designed to include 110 patients with locally advanced gastric adenocarcinoma who will be randomly assigned into two groups: experimental group (adebrelimab combined with SOX regimen) (n=55) and control group (SOX regimen) (n=55). The main efficacy indicators are pathological complete response rate (pCR). The secondary efficacy indicators are R0 resection rate, safety indicators (including surgical and drug treatment safety indicators). disease-free survival (DFS) and overall survival (OS). Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital (Xijing Hospital) of Air force Military Medical University (KY20232357-F-1).
Epistemonikos ID: fd3b6cab1ad97067a7887bd4e48ad34c8cdfc4b2
First added on: May 15, 2024