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ClinicalTrials.gov ID

NCT02725073

Lead Sponsor

Asan Medical CenterOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 2

Enrollment

32Estimated

Last Update Posted

Apr 14, 2016Estimated

Start Date

Jan 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

Official Title

Photodynamic Therapy Using a Novel Photosensitizer in Locally Advanced Hilar Cholangiocarcinoma

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.

• Treatment Response
• Adverse Events
• Feasibility

• Photodynamic therapy

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Asan Medical CenterOTHER

dhpark@amc.seoul.kr+82-2-3010-3194