Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma (PDT)

Photodynamic Therapy Using a Novel Photosensitizer in Locally Advanced Hilar Cholangiocarcinoma

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

Study Overview

• Status: Unknown
• Conditions: Feasibility; Adverse Events; Treatment Response
• Intervention / Treatment: Procedure: Photodynamic therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Recruiting
    • Asan Medical Center
    • Contact: Jun Ho Choi, MD; Email: mdcjh78@gmail.com
    • Contact: Do Hyun Park, MD, PhD; Phone Number: 82230103194; Email: dhpark@amc.seoul.kr
    • Principal Investigator: Do Hyun Park, MD, PhD
    • Sub-Investigator: Jun Ho Choi, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Do Hyun Park
    • Contact: Do Hyun Park, MD, PhD; Phone Number: +82-2-3010-3194; Email: dhpark@amc.seoul.kr
    • Contact: Jun Ho Choi, MD; Phone Number: +82-2-3010-3194; Email: mdcjh78@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Do Hyun Park, MD, PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: March 20, 2016
• First Submitted That Met QC Criteria: March 30, 2016
• First Posted (Estimate): March 31, 2016

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 12, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma; Klatskin Tumor
• Other Study ID Numbers: ERCP-PDT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES