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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-12-31

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.

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

photosensitizer(photofrin)

Intervention Type DRUG

photosensitizer(photofrin): 2mg/kg

630 nm laser irradiation (DIOMED)

Intervention Type DEVICE

630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.

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.

Group Type ACTIVE_COMPARATOR

photosensitizer(photofrin)

Intervention Type DRUG

photosensitizer(photofrin): 2mg/kg

630 nm laser irradiation (DIOMED)

Intervention Type DEVICE

630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.

Interventions

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photosensitizer(photofrin)

photosensitizer(photofrin): 2mg/kg

Intervention Type DRUG

630 nm laser irradiation (DIOMED)

630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.

Intervention Type DEVICE

Other Intervention Names

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photofrin DIOMED

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR