Two-arm Phase III Trial Comparing Different Time of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Partial remission rate
研究概览
简要总结
The therapy of photofrin PDT was effective in improving life quality of patients with advanced esophageal and/or gastric cardiac cancer and the time optimizing for employing laser irradiation was of great importance.The purpose of this study is to evaluate the clinical efficacy and adverse effects of Photodynamic Therapy (PDT) on esophageal and/or gastric cardiac cancer during different time after inject photofrin.
详细描述
The investigators plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma or gastric cardia adenocarcinoma from the Oct.2015. The patients will be divided into two groups. Group 1: Following intravenous administration of photofrin at dose of 2 mg/kg.b.w. as the photosensitizer, 630 nm laser irradiation (DIOMED) with 400 mW/cm was applied on each part of tumor for 750 seconds through cylinder diffusing quartz fibers localizing in the biopsy channel of a flexible endoscope at 24th. Group 2: Following intravenous administration of photofrin at dose of 2 mg/kg.b.w. as the photosensitizer, 630 nm laser irradiation (DIOMED) with 400 mW/cm was applied on each part of tumor for 750 seconds through cylinder diffusing quartz fibers localizing in the biopsy channel of a flexible endoscope at 48th.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In the esophagus, patients with severe dysplasia and carcinoma in situ
- •The patients have not received the surgery or chemo-radiotherapy.
- •Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L, ALT、AST≤2.5*N,Cr≤1.5*N.
- •Performance status score 0-2
排除标准
- •pregnant, lactating women
- •History of organ transplantation
- •The peripheral nervous system disorders
- •Severe infection
- •Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding
- •Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.
- •Other malignant tumor in recent 5 years.
研究组 & 干预措施
24 to 48 hours group
photosensitizer(photofrin): 2mg/kg, Diomed Surgical Diode Laser:400mv/cm irridiation 750 seconds, 24 to 48 hours: The injection of photosensitizer(photofrin) 24 to 48 hours light irradiation power.
630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.
干预措施: photosensitizer(photofrin) (Drug)
24 to 48 hours group
photosensitizer(photofrin): 2mg/kg, Diomed Surgical Diode Laser:400mv/cm irridiation 750 seconds, 24 to 48 hours: The injection of photosensitizer(photofrin) 24 to 48 hours light irradiation power.
630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.
干预措施: 630 nm laser irradiation (DIOMED) (Device)
48 to 72 hours group
photosensitizer(photofrin): 2mg/kg, Diomed Surgical Diode Laser:400mv/cm irridiation 750 seconds, 48 to 72 hours: The injection of photosensitizer(photofrin) 48 to 72 hours light irradiation power.
630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.
干预措施: photosensitizer(photofrin) (Drug)
48 to 72 hours group
photosensitizer(photofrin): 2mg/kg, Diomed Surgical Diode Laser:400mv/cm irridiation 750 seconds, 48 to 72 hours: The injection of photosensitizer(photofrin) 48 to 72 hours light irradiation power.
630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.
干预措施: 630 nm laser irradiation (DIOMED) (Device)
结局指标
主要结局
Partial remission rate
时间窗: 3 months
Photodynamic therapy for 3 months after the review of gastroscope for pathologic examination, to check the response rate
次要结局
- The recent incidence of adverse reactions(7-10 days)