Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma

Overview

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

Full Title of Study: “Photodynamic Therapy Using a Novel Photosensitizer in Locally Advanced Hilar Cholangiocarcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2017

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: photodynamic therapy
    • Photodynamic therapy with a novel photosensitizer and flexible laser catheter

Clinical Trial Outcome Measures

Primary Measures

  • Treatment response using the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
    • Time Frame: within 1 month
    • Response Evaluation Criteria in Solid Tumours (RECIST) criteria

Secondary Measures

  • Adverse events and overall survival
    • Time Frame: within 1 week
    • any procedural adverse events and overall survival

Participating in This Clinical Trial

Inclusion Criteria

1. Locally advanced cholangiocarcinoma confirmed to be unsuitable for surgical resection 2. Exhibiting disease progression without distant metastasis after conventional chemoradiation therapy at multidisciplinary team discussion in Asan Medical Center 3. Pathologically proven cholangiocarcinoma 4. have a negative pregnancy test if appropriate 5. ECOG(Eastern Cooperative Oncology Group) Score 0-2 6. patients to give informed consent and age more than >19 years Exclusion Criteria:

1. age less than 18 years 2. previous history of PDT 3. uncorrectable coagulopathy 4. refuse to participate 5. pregnancy 6. recent participation in another clinical research trial within 30 days 7. presence of porphyria or hypersensitivity to photosensitizer 8. Creatinine clearance < 45ml

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Asan Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Do Hyun Park, Associate Professor – Asan Medical Center
  • Overall Official(s)
    • Do Hyun Park, Md, PhD, Principal Investigator, Asan Medical Center
  • Overall Contact(s)
    • Do Hyun Park, MD, PhD, +82-2-3010-32194, dhpark@amc.seoul.kr

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