NCT06192186

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

The Safety and Efficacy of Adebrelimab Combined With SOX Regimen in Preoperative Neoadjuvant Therapy for Locally Advanced Gastric Adenocarcinoma Patients (ASOG-01)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Yang Jianjun, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Locally Advanced Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Adebrelimab combined with SOX regimen	Adebrelimab combined with SOX regimen preoperatively used 3 cycles(stop adebrelimab and S-1/oxaliplatin after 3 cycles and evaluate tumor staging)→ radical surgery (D2) →Postoperative selection of continued medication or cessation of treatment will base on the patient's pathological reports. Surgery should be performed within 3-6 weeks after 3 cycles of preoperative neoadjuvant therapy.
DRUG	Placebo combined with SOX (S-1/oxaliplatin) regimen	Placebo combined with SOX (S-1/oxaliplatin) regimen preoperatively used 3 cycles (stop placebo and S-1/oxaliplatin after 3 cycles and evaluate tumor staging) → radical surgery (D2) →Postoperative selection of continued medication or cessation of treatment will base on the patient's pathological reports. Surgery should be performed within 3-6 weeks after 3 cycles of preoperative neoadjuvant therapy.

Timeline

• Start date: 2023-12-30
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-01-05
• Last updated: 2024-01-29

Locations

1 site across 1 country: China