Study of Epigallocatechin-3-gallate (EGCG) for Supportive and Symptomatic Management in Patients With Esophageal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
The main symptom of patients with advanced esophageal cancer is eating obstruction. In clinical practice, patients need to wait for a long time before anti-tumor treatment, which will lead to a rapid decline in the quality of life and nutritional status of patients, and severe patients sometimes need to place nasointestinal feeding tubes or endoscopic stents. EGCG has been shown to have antioxidant, anti-inflammatory and anti-tumor effects . The complex effects of EGCG may improve esophageal obstruction during the waiting period before antineoplastic therapy. The purpose of this phase I study was to explore the safety, recommended dose and preliminary efficacy of EGCG solution in the treatment of esophageal obstruction.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed pathological esophageal squamous cell carcinoma
- •≥18 years old
- •the Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
- •no previous anti-tumor treatment
- •no esophageal bleeding or fistula
- •adequate hemocyte count, normal hepatic and renal functions
- •Esophageal obstruction classified as grade 2 or grade 3 according to Stooler's dysphagia score
排除标准
- •lactating or pregnant women
- •known hypersensitivity or allergy to any kind green tea extract
- •placement of small intestinal feeding tube or endoscopic stent treatment
- •unable or refusing to take oral liquids
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: baseline and up to 7 days post-treatment
the toxicities will be reported by describing Adverse Events (AE) per CTCAE v5.0, by dose level, and type and grade of toxicity
Recommended phase 2 dose (RP2D)
时间窗: baseline and up to 7 days post-treatment
the toxicities will be reported by describing Adverse Events (AE) per CTCAE v5.0, by dose level, and type and grade of toxicity
Dose limiting toxicity (DLT)
时间窗: baseline and up to 7 days post-treatment
the toxicities will be reported by describing Adverse Events (AE) per CTCAE v5.0, by dose level, and type and grade of toxicity
次要结局
- change in blood biochemical indicators(baseline and up to 8 days post-treatment)
- Imaging objective response rate(Change from Baseline esophageal stenosis size at 7 days)
- Symptom objective response rate(baseline and up to 7 days post-treatment)
研究者
Han Xi Zhao
Principal Investigator
Shandong Cancer Hospital and Institute