Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma

Feasibility Clinical Trial

— PDT  

Official title:

Photodynamic Therapy Using a Novel Photosensitizer in Locally Advanced Hilar Cholangiocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02725073
• Other study ID #: ERCP-PDT
• 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

Related Conditions & MeSH terms

• Adverse Events
• Cholangiocarcinoma
• Feasibility
• Klatskin's Tumor
• Treatment Response

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