Clinical Study of Time Optimizing of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer

The First Affiliated Hospital of Henan University of Science and Technology40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stage I Esophageal Adenocarcinoma

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Partial remission rate

Photodynamic therapy for 3 months after the review of gastroscope for pathologic examination, to check the response rate

Time frame: 3 months

Secondary Outcomes

The recent incidence of adverse reactions

Observe 7-10 days postoperatively in patients with the ratio of pain and difficulty swallowing

Time frame: 7-10 days