Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma

Phase 2

• Conditions: Treatment Response; Feasibility; Adverse Events
• Interventions: Procedure: Photodynamic therapy

• Registration Number: NCT02725073
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-20
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-03-31
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
photodynamic therapy	Photodynamic therapy	Photodynamic therapy with a novel photosensitizer and flexible laser catheter

Primary Outcome Measures

Name	Time	Method
Treatment response using the Response Evaluation Criteria in Solid Tumours (RECIST) criteria	within 1 month	Response Evaluation Criteria in Solid Tumours (RECIST) criteria

Secondary Outcome Measures

Name	Time	Method
Adverse events and overall survival	within 1 week	any procedural adverse events and overall survival

Trial Locations

Locations (2)

Do Hyun Park; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of