Clinical trial NCT02725073: Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma
Official title: Photodynamic Therapy Using a Novel Photosensitizer in Locally Advanced Hilar Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Treatment Response
Adverse Events
Feasibility
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 outcomes:
measure: Treatment response using the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
timeFrame: within 1 month
Secondary outcomes:
measure: Adverse events and overall survival
timeFrame: within 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Do Hyun Park
Study officials:
affiliation: Asan Medical Center
name: Do Hyun Park, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References: