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Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma (PDT)

Primary Purpose

Treatment Response, Adverse Events, Feasibility

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Photodynamic therapy
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Response

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical CenterRecruiting
  • Do Hyun ParkRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

photodynamic therapy

Arm Description

Photodynamic therapy with a novel photosensitizer and flexible laser catheter

Outcomes

Primary Outcome Measures

Treatment response using the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
Response Evaluation Criteria in Solid Tumours (RECIST) criteria

Secondary Outcome Measures

Adverse events and overall survival
any procedural adverse events and overall survival

Full Information

First Posted
March 20, 2016
Last Updated
April 12, 2016
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02725073
Brief Title
Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma
Acronym
PDT
Official Title
Photodynamic Therapy Using a Novel Photosensitizer in Locally Advanced Hilar Cholangiocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Response, Adverse Events, Feasibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
photodynamic therapy
Arm Type
Experimental
Arm Description
Photodynamic therapy with a novel photosensitizer and flexible laser catheter
Intervention Type
Procedure
Intervention Name(s)
Photodynamic therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Treatment response using the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
Description
Response Evaluation Criteria in Solid Tumours (RECIST) criteria
Time Frame
within 1 month
Secondary Outcome Measure Information:
Title
Adverse events and overall survival
Description
any procedural adverse events and overall survival
Time Frame
within 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Do Hyun Park, MD, PhD
Phone
+82-2-3010-32194
Email
dhpark@amc.seoul.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Ho Choi, MD
Email
mdcjh78@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Do Hyun Park, Md, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Do Hyun Park, MD, PhD
Phone
82230103194
Email
dhpark@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Jun Ho Choi, MD
Email
mdcjh78@gmail.com
First Name & Middle Initial & Last Name & Degree
Do Hyun Park, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jun Ho Choi, MD
Facility Name
Do Hyun Park
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Do Hyun Park, MD, PhD
Phone
+82-2-3010-3194
Email
dhpark@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Jun Ho Choi, MD
Phone
+82-2-3010-3194
Email
mdcjh78@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma

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