NCT02628665

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The First Affiliated Hospital of Henan University of Science and Technology · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	photosensitizer(photofrin)	photosensitizer(photofrin): 2mg/kg
DEVICE	630 nm laser irradiation (DIOMED)	630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-10-01
• Completion: 2019-12-01
• First posted: 2015-12-11
• Last updated: 2015-12-11

Locations

1 site across 1 country: China