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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02725073
Other study ID # ERCP-PDT
Secondary ID
Status Recruiting
Phase Phase 2
First received March 20, 2016
Last updated April 12, 2016
Start date January 2016
Est. completion date December 2017

Study information

Verified date April 2016
Source Asan Medical Center
Contact Do Hyun Park, MD, PhD
Phone +82-2-3010-32194
Email dhpark@amc.seoul.kr
Is FDA regulated No
Health authority Korea: Asan Medical Center
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Do Hyun Park Seoul

Sponsors (1)

Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment response using the Response Evaluation Criteria in Solid Tumours (RECIST) criteria Response Evaluation Criteria in Solid Tumours (RECIST) criteria within 1 month No
Secondary Adverse events and overall survival any procedural adverse events and overall survival within 1 week Yes
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