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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Two-arm Phase III Trial Comparing Different Time of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer

Conditions
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Stage I Esophageal Adenocarcinoma, Stage II Esophageal Adenocarcinoma, Stage III Esophageal Adenocarcinoma, Stage I Esophageal Squamous Cell Carcinoma, Stage II Esophageal Squamous Cell Carcinoma, Stage III Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: photosensitizer(photofrin)
* Device: 630 nm laser irradiation (DIOMED)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 24 to 48 hours group<br>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. | Drug: photosensitizer(photofrin)<br>* photosensitizer(photofrin): 2mg/kg<br>* Other names: photofrin;Device: 630 nm laser irradiation (DIOMED)<br>* 630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.<br>* Other names: DIOMED;|
| Active Comparator: 48 to 72 hours group<br>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. | Drug: photosensitizer(photofrin)<br>* photosensitizer(photofrin): 2mg/kg<br>* Other names: photofrin;Device: 630 nm laser irradiation (DIOMED)<br>* 630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.<br>* Other names: DIOMED;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial remission rate | Photodynamic therapy for 3 months after the review of gastroscope for pathologic examination, to check the response rate | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The recent incidence of adverse reactions | Observe 7-10 days postoperatively in patients with the ratio of pain and difficulty swallowing | 7-10 days |