The Safety and Efficacy of Adebrelimab Combined With SOX Regimen in Preoperative Neoadjuvant Therapy for Locally Advanced Gastric Adenocarcinoma Patients (ASOG-01)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- pCR
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
This study is a double-blind design, which blinds both the researcher and the patient. Considering that adebrelimab is administered by injection and the solvent is a 5% glucose solution, therefore, the control group will use 5% glucose solution as placebo. They are not easily distinguishable in appearance, so patients can be blinded. During the research process, patient grouping information will be randomly extracted by Jialin Luo, and kept confidential to other researchers (other members who responsible for follow-up and analysis) until unblinding. Meanwhile, Jialin Luo did not participate in the follow-up and statistical analysis of patients after medication.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Adebrelimab combined with SOX regimen (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.
干预措施: Placebo combined with SOX (S-1/oxaliplatin) regimen (Drug)
结局指标
主要结局
pCR
时间窗: 48 months
pathological complete response rate (pCR)
次要结局
- R0 resection rate(48 months)
- AE(48 months)
- DFS(48 months)
- OS(48 months)
研究者
Yang Jianjun, PhD
Professor from Xijing Hospital
Xijing Hospital