Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma

NCT ID: NCT02725073

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-12-31

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.

Conditions

Treatment Response; Adverse Events; Feasibility

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

photodynamic therapy

Photodynamic therapy with a novel photosensitizer and flexible laser catheter

Group Type: EXPERIMENTAL

Photodynamic therapy

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Do Hyun Park

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Do Hyun Park, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Do Hyun Park

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Do Hyun Park, MD, PhD

Role: CONTACT

dhpark@amc.seoul.kr

+82-2-3010-32194

Jun Ho Choi, MD

Role: CONTACT

mdcjh78@gmail.com

Facility Contacts

Do Hyun Park, MD, PhD

Role: primary

dhpark@amc.seoul.kr

82230103194

Jun Ho Choi, MD

Role: backup

mdcjh78@gmail.com

Do Hyun Park, MD, PhD

Role: primary

dhpark@amc.seoul.kr

+82-2-3010-3194

Jun Ho Choi, MD

Role: backup

mdcjh78@gmail.com

+82-2-3010-3194

Other Identifiers

ERCP-PDT

Identifier Type: -

Identifier Source: org_study_id