Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Photodynamic Therapy Using a Novel Photosensitizer in Locally Advanced Hilar Cholangiocarcinoma

Conditions
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Treatment Response, Adverse Events, Feasibility

Intervention / Treatment
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* Procedure: Photodynamic therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Locally advanced cholangiocarcinoma confirmed to be unsuitable for surgical resection Exhibiting disease progression without distant metastasis after conventional chemoradiation therapy at multidisciplinary team discussion in Asan Medical Center Pathologically proven cholangiocarcinoma have a negative pregnancy test if appropriate ECOG(Eastern Cooperative Oncology Group) Score 0-2 patients to give informed consent and age more than >19 years Exclusion Criteria: age less than 18 years previous history of PDT uncorrectable coagulopathy refuse to participate pregnancy recent participation in another clinical research trial within 30 days presence of porphyria or hypersensitivity to photosensitizer Creatinine clearance < 45ml

Ages Eligible for Study
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Minimum Age: 19 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: photodynamic therapy<br>Photodynamic therapy with a novel photosensitizer and flexible laser catheter | Procedure: Photodynamic therapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response using the Response Evaluation Criteria in Solid Tumours (RECIST) criteria | Response Evaluation Criteria in Solid Tumours (RECIST) criteria | within 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and overall survival | any procedural adverse events and overall survival | within 1 week |