Adverse Events, Feasibility, Treatment Response
Conditions
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.
Interventions
PROCEDUREPhotodynamic 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
Sponsors
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment response using the Response Evaluation Criteria in Solid Tumours (RECIST) criteria | within 1 month | Response Evaluation Criteria in Solid Tumours (RECIST) criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events and overall survival | within 1 week | any procedural adverse events and overall survival |
Countries
South Korea
Contacts
Primary ContactDo Hyun Park, MD, PhD
Backup ContactJun Ho Choi, MD
Outcome results
None listed