Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Locally Advanced Esophageal Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
This prospective study aims to clarify the clinical efficacy and survival prognosis of neoadjuvant immune checkpoint inhibitor (ICI) combined with chemotherapy for esophageal cancer. It also explores predictive biomarkers and potential therapeutic targets for locally advanced esophageal cancer based on plasma metabolomics and peripheral blood immune cell clustering analysis. Each patient received 2-3 cycles of neoadjuvant immunotherapy with programmed cell death 1 (PD-1) blockade in combination with albumin paclitaxel and platinum. Exploratory analysis of plasma metabolomics combined with peripheral blood subsets of immune cells can reveal biomarkers that predict the efficacy and prognosis of patients undergoing neoadjuvant immunotherapy for locally advanced esophageal cancer, which also provide new ideas for the selection of immune adjuvants and therapeutic targets in ICIs combination therapy strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years and ≤89 years;
- •pathological histological examination confirmed the diagnosis of esophageal squamous cell carcinoma and esophageal adenocarcinoma;
- •clinical stage II-IVA;
- •adequate organ function;
- •no previous chemotherapy or radiotherapy;
- •voluntarily signed informed consent.
排除标准
- •the presence of concurrent malignancies that interfere with the prognosis of esophageal cancer;
- •patients with immunodeficiency or autoimmune diseases that seriously affect the body's immune system, such as those who test positive for HIV;
- •patients undergoing systemic corticosteroid or other immunosuppressive treatments;
- •patients with a history of allergy to the components of this test drug.
研究组 & 干预措施
Neoadjuvant PD-1 Blockade Plus Chemotherapy
PD-1 blockade, 200 mg, IV., every 3 weeks, 2-3 cycles； Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles； Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.
干预措施: PD-1 blockade (Drug)
Neoadjuvant PD-1 Blockade Plus Chemotherapy
PD-1 blockade, 200 mg, IV., every 3 weeks, 2-3 cycles； Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles； Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.
干预措施: Albumin paclitaxel (Drug)
Neoadjuvant PD-1 Blockade Plus Chemotherapy
PD-1 blockade, 200 mg, IV., every 3 weeks, 2-3 cycles； Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles； Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.
干预措施: Carboplatin/Nedaplatin (Drug)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: 24 months
Disease-free survival was defined as the time from randomization until the first documented disease recurrence or death due to any cause.
次要结局
- Pathologic complete remission (PCR)(4 weeks after surgery)
- Major Pathologic Response (MPR)(4 weeks after surgery)
- Overall survival (OS)(24 months)