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

Phase 4

Recruiting

• Conditions: Locally Advanced Gastric Adenocarcinoma
• Interventions: Drug: Placebo combined with SOX (S-1/oxaliplatin) regimen; Drug: Adebrelimab combined with SOX regimen

• Registration Number: NCT06192186
• Lead Sponsor: Yang Jianjun, PhD

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-19
• Study Start: 2023-12-30
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-05
• Last Update Submitted: 2024-01-26
• Last Update Posted: 2024-01-29
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo combined with SOX (S-1/oxaliplatin) regimen	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.
Adebrelimab combined with SOX regimen	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.

Primary Outcome Measures

Name	Time	Method
pCR	48 months	pathological complete response rate (pCR)

Secondary Outcome Measures

Name	Time	Method
DFS	48 months	disease-free survival
R0 resection rate	48 months	R0 resection rate
AE	48 months	the incidence of adverse events (AE)
OS	48 months	overall survival

Trial Locations

Locations (1)

The First Affiliated Hospital of the Air Force Medical University; 🇨🇳 Xi'an, China