NCT04258657Unknown2 期
Neoadjuvant Chomotherapy With Paclitaxel-albumin and S-1 for Advanced Gastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- DFS
研究概览
简要总结
This is a interventional clinical trial to assess the efficacy and safety of combinational therapy of paclitaxel-albumin and S-1 for the neoadjuvant chemotherapy of advanced gastric cancer.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically diagnosed gastric adenocarcinoma
- •Type II and III esophageal-gastric-junction malignancy
- •AJCC stage II-III
- •No contraindications for surgery, radical resection can be expected
- •KPS>60; ECOG score:0-2
- •Expactant survival period>6 months
- •No other major health issues
- •Lab results within 7 days before inclusion must satisfy:
- •neutrophil≥1.5×109/L
- •PLT≥100×109/L
- •hemogloblin≥90g/L
- •ALT,AST<1.5 upper limit
- •Tbil≤1.0×UNL
- •serum creatinine<1.5×UNL
- •PT-INR/PTT<1.7 upper limit
- •with measurable lesion according to RECIST1.1 criteria
- •with consent
- •co-operative
排除标准
- •with other major health issue
- •allergic to relevant drugs
- •experienced any other drug therapy with 4 weeks before inclusion
- •experienced any drug therapy for gastric cancer at anytime
- •diagnosed with any other malignancy within the past 5 years
- •women at child-bearing age; pregnant or breast-feeding women
- •with severe heart disease
- •with upper GI digestion or disrupted absorption
- •with peripheral neural disease
- •with transplated organs or organs having been resected for transplantation
- •known DPD deficiency
- •with uncontrolled infection
研究组 & 干预措施
Paclitaxel-albumin and S-1
Experimental
干预措施: paclitaxel-albumin and S-1 (Drug)
结局指标
主要结局
DFS
时间窗: 3-year
disease free survival
次要结局
- ORR(3-year)
- OS(3-year)
研究者
Zhongtao Zhang
Professor
Beijing Friendship Hospital
研究点 (1)
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