Esophageal Cancer Clinical Trial
Official title:
Safety Study of Photodynamic Therapy Using Photocyanine Injection in Treating Patients With Malignant Tumors
The purpose of this study is to determine the safety and maximum tolerated dose of
Photocyanine injection in photodynamic therapy of malignant tumor (especially skin cancer
and esophageal cancer).
Projected accrual: A total of 18-24 patients will be accrued for this study.
Photocyanine injection is a type of cyanine compound, which was invented in Fuzhou
university by Professor Chen; it's maximum absorption wave is 670 nm. Patients receive
intravenous injection of Photocyanine injection, and 24 hours later, patients undergo
photodynamic therapy.
Cohorts of 3-6 patients receive escalating doses of Photocyanine Injection and photodynamic
therapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 1 of 3 patients experiences dose-limiting toxicity. Three additional
patients are treated at the MTD.
After completion of study therapy, patients are followed for up to 2 weeks.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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