Stage I Esophageal Adenocarcinoma, Stage I Esophageal Squamous Cell Carcinoma, Stage II Esophageal Adenocarcinoma, Stage II Esophageal Squamous Cell Carcinoma, Stage III Esophageal Adenocarcinoma, Stage III Esophageal Squamous Cell Carcinoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGphotosensitizer(photofrin)
photosensitizer(photofrin): 2mg/kg
DEVICE630 nm laser irradiation (DIOMED)
630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.
Sponsors
The First Affiliated Hospital of Henan University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Partial remission rate | 3 months | Photodynamic therapy for 3 months after the review of gastroscope for pathologic examination, to check the response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The recent incidence of adverse reactions | 7-10 days | Observe 7-10 days postoperatively in patients with the ratio of pain and difficulty swallowing |
Countries
China
Contacts
Primary ContactShegan Gao, Doctor
Backup ContactTanyou Shan, Master
Outcome results
None listed