NCT02725073

Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma

Photodynamic Therapy Using a Novel Photosensitizer in Locally Advanced Hilar Cholangiocarcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety and efficacy of photodynamic therapy with a novel photosensitizer and a flexible laser probe in locally advanced hilar cholangiocarcinoma.

Detailed description

Photodynamic therapy (PDT) is a way of producing tissue necrosis with light after prior administration of a photosensitizing agent. The most important advantages include the possibility of combining PDT with other target therapies and repeat the process as needed with a favorable outcomes. The combination of diverse therapeutic modalities is one of the new strategies to enhance oncologic treatments for pancreatic cancer. In order to overcome the limitations of each treatment modalities and to prevent the development of resistance, the application of PDT combined with target therapies, without increasing the toxicity for the patient, is being widely investigated. PDT has been only extensively studied for the treatment of various superficial skin cancers in the Europe but not available in the United States and Japan due to the overlapping treatment fields. In Korea, the use of first-generation and second-generation photosensitizers are part of the study of Gastroenterology, Dermatology, Otolaryngology, and Gynecology. Recently, although the investigators have introduced PDT using novel photosensitizers has not yet been used for the treatment of pancreatic cancers. This study aim to determine the safety and efficacy of photodynamic therapy with a novel photosensitizer in locally advanced hilar cholangiocarcinoma.

Conditions

• Treatment Response
• Adverse Events
• Feasibility

Interventions

Type	Name	Description
PROCEDURE	Photodynamic therapy	Photolon (Belmedpreparaty, Minsk, Republic of Belarus), was administered intravenously at a dose of 2.5 mg/kg at 3 hours before illumination. After advancing a catheter (7 F inner sheath of a plastic stent delivery catheter \[MAJ-1419; Olympus America, Center Valley, Pa., USA\]) across the biliary stricture using a 0.035-in guidewire, the cylindrical diffuser is inserted into a catheter at the level of the stricture to be treated. Photoactivation (660 nm with a light dose of 100-150J/cm2, and fluence of 0.8-1W/cm2; UPL- FDT; LEMT Research \& Development Private Unitary Enterprise, Minsk, Republic of Belarus) is performed

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-03-31
• Last updated: 2016-04-14

Locations

2 sites across 1 country: South Korea